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UK announces £4M for 5 COVID-19 projects in vaccine immunity and boosters

Five new UK COVID-19 research projects were announced on Thursday, which will receive a total of over £4 million from UK Research and Innovation, to study the durability of vaccine responses, low responses linked with health conditions, and the effect of booster doses.

The studies will research the strength and durability of the immune response in a wide range of people, including those with conditions that result in a weakened immune system, such as HIV, B cell lymphoma, inflammatory bowel disease and chronic myeloid leukaemia; people who are obese; healthcare workers; and people in the general population who have a weak immune response to vaccination.

The research aims to determine how long immunity from vaccination lasts; identify groups of people at risk from low vaccine responses; and determine if and when vaccine boosters are required for these groups, as well as the wider population.

One of the studies will potentially involve administering booster doses to participants with a low vaccine response and monitoring the effect it has on their immune systems.

Another study, conducted across the UK, South Africa and Brazil, will monitor immunity and vaccine effectiveness to virus variants.

Researchers in another study will monitor the effect the effect of different levels of weight loss on the immune response of 200 people with severe obesity, who are taking part in an existing weight loss study.

Rob Buckle, chief scientist of the Medical Research Council said vaccines have proved to be an invaluable tool in the fight against COVID-19, but there are still questions to be answered. “These studies will help provide guidance to policy makers and clinicians on a range of issues, including when and for whom booster shots are necessary,” Buckle said.

EMA approves new manufacturing site for BioNTech’s COVID-19 vaccines

The European Medicines Agency (EMA) gave approval for a new manufacturing site to start producing the Pfizer/BioNTech COVID-19 vaccine, a move that will increase capacity and supply of COVID-19 in the EU.

The facility in Saint Rémy sur Avre, France, operated by Delpharm and will manufacture finished product and is expected to supply an additional 51 million doses in 2021 alone.

EMA has also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany. That will increase the capacity to manufacture the active substance that forms the basis of the vaccine by approximately 410 million doses in 2021.

In addition, EMA gave its stamp of approval to an additional US manufacturing facility for Moderna’s COVID-19 vaccine, in Bloomington, Indiana.

These recommendations do not require a European Commission decision, which means the sites can produce vaccines for the EU market immediately.

ERC funded research shows mutation rate of Covid-19 virus 50% higher than thought

The SARS-CoV-2 virus that causes Covid-19 mutates almost once a week, significantly more than the rate estimated previously, according to a new European Research Council funded study by scientists at Edinburgh and Bath universities. They say their findings indicate that new variants could emerge more quickly than was thought.

SARS-CoV-2 was thought to mutate about once every two weeks, but this estimate overlooked many mutations that happened but were never sequenced. That is because they were so called negative mutations which don’t survive long enough to be sequenced and so are missing from calculations of the mutation rate.

Allowing for these missing mutations, the researchers estimate the true mutation rate of the virus is at least 50% higher than previously thought.

The researchers say their findings, published in the journal Genome Biology and Evolution, reinforce the need to isolate individuals with weakened immune systems who struggle to contain the virus.

Laurence Hurst, professor of evolutionary genetics at Bath University, said, “With the great number of genomes of SARS-CoV-2 now sequenced, we can say something about both how many and why these mutations are missing, despite the fact that we can’t fully study them directly.”

EU approves €108M aid for Danish vaccines company

The European Commission has approved a €108 million Danish aid measure for coronavirus-related research and development at vaccines specialist Bavarian Nordic, under the state aid temporary framework.

The public support will take the form of a repayable advance to support the development of a coronavirus vaccine in-licensed by Bavarian Nordic from two other Danish biotechs, which is currently in phase II clinical development. The money will fund the phase III trial to confirm safety and demonstrate efficacy, develop manufacturing processes, and work to secure regulatory approvals.

The Commission said the aid is in line with the temporary state aid framework. In particular, it will cover less than 80% of the R&D costs and will be fully recovered if the vaccine is approved.

Pfizer/BioNTech COVID-19 vaccine gets full US approval

German biotech BioNTech said the US Food and Drug Administration has granted a licence to its COVID-19 vaccine Comirnaty, replacing the emergency use authorisation currently in force.

That makes Comirnaty the first vaccine against SARS-Cov-2 to have been given full approval by the FDA.

The vaccine has been available in the US under emergency use authorisation since 11 December 2020, on the basis of initial data from the pivotal phase III clinical trial.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Janet Woodcock. “While millions of people have already safely received COVID-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated,” she said.

For full approval, BioNTech and partner Pfizer submitted longer-term data from the phase III trial, based on the vaccine’s efficacy and safety profile up to six months after the second dose. After submission in May 2021 the file was granted priority review in July.

“Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants,” said Ugur Sahin, CEO and co-founder of BioNTech

Pfizer and BioNTech now plan to seek FDA approval for a third, booster dose, of Comirnaty.

UK orders further 35M doses of Pfizer/BioNTech COVID-19 vaccine

Coinciding with the US Food and Drug Administration announcing full approval of Pfizer/BioNtech’s COVID-19 vaccine, the UK government said it placed an order for 35 million more doses, to be delivered from the second half of next year.

The order was described as part of preparations to futureproof the country from the threat of COVID-19 and its variants.

At present plans are being laid for a booster programme later this year, details of which are due to be announced in September.

The Department of Health said COVID-19 vaccines have saved 95,200 lives in the UK. Vaccination has also prevented 82,100 hospitalisations and 23.9 million infections in England, according to the latest data.

Israeli company gets European approval for COVID-19 severity test

MeMed Ltd has received the CE Mark in Europe for its new diagnostic MeMed COVID-19 Severity, a 15 minute test to assess which patients arriving in accident and emergency with COVID-19 infections are likely to progress to severe disease.

The test measures multiple proteins from a blood sample and applies machine learning to stratify the risk that a patient with COVID-19 disease is likely to experience severe outcomes.

The test is designed to identify patients who will need escalated care and those who may be safely discharged from the hospital and instructed to self-isolate at home.

With the CE mark, Haifa, Israel-based MeMed can now commercialize the test to help identify COVID-19 patients at risk of severe outcomes, and enable clinicians to manage what is increasingly likely to become an endemic situation, said Eran Eden, MeMed’s co-founder and CEO. MeMed COVID-19 Severity is also relevant for authorities looking at preparedness for future pandemics.

“It is another exciting step in the company’s long-term vision of harnessing the power of the host-immune response in order to transform the way infections are detected and managed,” Eran said.

Helping it to reach this point, in 2015 MeMed was awarded a Horizon Europe grant of €3 million.

The company recently published the results from a multinational clinical study, demonstrating the ability of its test to accurately predict severe COVID-19 respiratory failure. MeMed has also completed an additional independent multinational validation study, with the results due to be published in the coming months.

“Highly sensitive and accurate diagnostic and prognostic tests are key tools for clinicians, said Sergey Motov, professor of Emergency Medicine at Maimonides Medical Centre in New York “As an ER doctor myself, I am fascinated by the potential for host immune response technologies to help predict patient outcomes.” With tools like MeMed COVID-19 Severity doctors can assess the likelihood of patients suffering from severe complications, enabling tailored treatments or discharge if the risk of deteriorating is low, Motov said.

New test could be used to self monitor COVID-19 antibodies over time

Researchers at Birmingham University have published an article demonstrating a new spike antibody lateral flow device is able to monitor antibody response following vaccination or natural infection with SARS-CoV-2 over time.

The paper shows differences in strength of antibody response with the Pfizer and AstraZeneca vaccines, and in the natural antibody responses to the original variant of the virus, first identified in Wuhan, China, around which the vaccines are designed.

The research also shows that these antibodies cross-react to the spike protein of different variants, such as the Delta variant that originated in India and which is now responsible for most infections in Europe.

The study was conducted using a lateral flow device called AbC-19TM LFD, developed by UK diagnostics specialist Abingdon Health. Unlike many of the lateral flow tests on the market, the test is designed to identify responses to different COVID-19 variants.

With the successful roll-out of vaccinations, it is now imperative to monitor the neutralising antibody levels in the worldwide population, to maintain the safety of the public and instil confidence in people as they return to normal life, said Chris Yates, CEO of Abingdon Health

“This study demonstrates how AbC-19TM can be used to monitor antibody response alongside vaccines, as well as the neutralising antibody response following natural infection. The AbC-19TM test will allow individuals to know their own status, which is becoming a growing concern, and allow healthcare agencies and healthcare professionals worldwide to manage the continued vaccination roll-out and to develop effective and targeted booster vaccination programmes,” Yates said.

In addition, the study also shows the ability of the company to change the format of the test if other variants of concern emerge that generate a different antibody response.

Next month, Abingdon intends to make a supplementary product available, initially for research use only, which provides a semi-quantitative result, indicating the strength of antibody response and possibly immunity.

Another COVID-19 vaccine on the way

The European Medicines Agency has started a rolling review of Sanofi Pasteur’s COVID-19 vaccine Vidprevtyn.

The decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies against the SARS-CoV-2 virus that causes COVID-19, and may help protect against the disease.

EMA says it will evaluate data as they become available, with the rolling review continuing until enough evidence is available for a formal marketing authorisation application.

The agency said it cannot predict the overall timelines, but should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

Vidprevtyn is a protein-based vaccine that contains a laboratory-grown version of the spike protein found on the surface of SARS-CoV-2. It also contains an adjuvant to help strengthen the immune response to the vaccine.

Trade-related bottlenecks, not IP rights to blame for low access to COVID-19 vaccines in poorer countries

The World Trade Organisation published a list of trade related problems it says are to blame for limited access to COVID-19 vaccines in poorer countries, as it sat down with the World Health Organisation to discuss how to address the problem.

The private discussion, aimed to identify obstacles and propose solutions for increasing vaccine rates and bridging the wide gap in vaccination rates between rich and poor countries.

Participants described current and projected production volumes as well as plans for new investments in production capacity. They shared experiences about specific supply chain bottlenecks they were encountering, from export restrictions and raw material shortages and onerous regulatory processes, and exchanged ideas on how these might be addressed.

They also discussed issues around the transfer of know-how and technology, as well as factors influencing decisions on licensing intellectual property.

While there was broad agreement on the importance of keeping supply chains open and predictable, different perspectives were expressed on the proposed waiver of the WTO's Trade-Related Intellectual Property Rights Agreement in relation to vaccines and other products needed to combat COVID-19.

COVID-19 vaccine inequity to cut $38B from GDP of poorer countries in 2021

Low-income countries would add $38 billion to their GDP forecast for 2021 if they had the same COVID-19 vaccination rates as high-income countries, according to new data released today by the United Nations Development Programme, the World Health Organisation (WHO) and Oxford University.

As a result, global economic recovery is at risk if vaccines are not equitably manufactured, scaled up and distributed, with COVID-19 vaccine inequity having a lasting impact on socio-economic recovery in poorer countries.

The new COVID-19 Vaccine Equity Dashboard, combines the latest information on COVID-19 vaccination with the most recent socio-economic data, to illustrate why accelerating vaccine equity is not only critical to saving lives but also to driving a faster and fairer recovery with benefits for all.

“In some low- and middle-income countries, less than 1% of the population is vaccinated – this is contributing to a two-track recovery from the COVID-19 pandemic”, said Achim Steiner of the UN development programme.

“Vaccine inequity is the world’s biggest obstacle to ending this pandemic and recovering from COVID-19,” said Tedros Adhanom Ghebreyesus, director general of the World Health Organisation.

The Global Dashboard breaks down the impact of accessibility against a target for countries to vaccinate their at-risk populations, first to reduce mortality and protect the health system, and then move on to vaccinating larger shares of the population to reduce disease burden and re-open socio-economic activity.

EU-funded Swiss Zoo in a test tube to help prevent development of COVID-19 variants

Since the beginning of the pandemic, several reports have indicated that SARS-CoV-2 has been transmitted from humans to animals, as evidenced by the transmission of the virus between keepers and tigers and lions in the Bronx Zoo in New York.

However, to date the full range of animal species that are susceptible to the viral infection remains unclear. Conventionally, that would be assessed experimentally by infecting a large variety of animal species with SARS-CoV-2, but researchers at the University of Bern have used their knowledge of in vitro cell culture models of the human respiratory tract to create a large collection of cell models from various domesticated and wild animals.

This will be an important resource in controlling the pandemic. "This will benefit the general public since it will help prevent new SARS-CoV-2 variants from developing in animal reservoirs and potentially being reintroduced into the human population, to which the current vaccines may not be protective," said Ronald Dijkman, from the Institute for Infectious Diseases at the University of Bern.

Currently, Swiss research funding from the EU is under threat. The work on the test tube zoo was supported by the European Commission’s Marie Sklodowska-Curie Innovative Training Network, with the Swiss National Science Foundation, the German Federal Ministry of Education and Research, and the Swiss Federal Food Safety and Veterinary Office.

The team isolated airway epithelial cells from tissue from deceased animals and created a cell biobank from different animal species that can be used to determine whether these animals can be infected with SARS-CoV-2.

No live animal experiments were involved. To date, the cell biobank contains primary cells from a rhesus macaque, cat, ferret, dog, rabbit, pig, cattle, goat, llama, camel, and two bat species.

"Our collection is unique, and thus far we are the first that have used such a large collection of advanced in vitro cell culture models from various domesticated and wildlife animal species to assess their susceptibility to SARS-CoV-2 infection,” Dijkman said.

The researchers found their in vitro results agree well with previously published studies using live animals to assess susceptibility to SARS-CoV-2 infection. For example, the researchers observed that SARS-CoV-2 replicated in the cell models of monkey and cats, without the need for the virus to adapt.

"Our findings, together with the reports from previously documented spillover events, indicate that close surveillance of these animals and other close relatives, whether they live in the wild, captivity or households, is necessary,” said Dijkman.

Anglo-Italian researchers show COVID-19 antibodies persist at least nine months after infection

Testing of an entire Italian town shows antibody levels remain high nine months after SARS-CoV-2 infection, whether symptomatic or asymptomatic, according to researchers from the University of Padua and Imperial College London.

They tested more than 85% of the 3,000 residents of Vo', Italy, in February - March 2020 for infection with SARS-CoV-2, the virus that causes COVID-19, and then tested them again in May and November 2020 for antibodies against the virus.

The team found that 98.8% of people infected in February - March showed detectable levels of antibodies in November. There was no difference between people who had suffered symptoms of COVID-19 and those that had been symptom-free. The results are published in the journal Nature Communications.

Antibody levels were tracked using three assays that each detected different antibodies generated in response to different parts of the virus. While all antibody types showed some decline between May and November, the rate of decay differed.

The team also found cases of antibody levels increasing in some people, suggesting potential re-infections with the virus, providing a boost to the immune system.

Ilaria Dorigatti, from the MRC Centre for Global Infectious Disease Analysis at Imperial College, said, "We found no evidence that antibody levels between symptomatic and asymptomatic infections differ significantly, suggesting that the strength of the immune response does not depend on the symptoms and the severity of the infection.”

However, the study does shows that antibody levels vary. This means that caution is needed when comparing estimates of infection levels in a population obtained in different parts of the world with different tests and at different times.

Testing in May showed 3.5% of the Vo' population had been exposed to the virus, even though not all of these subjects were aware of their exposure, given the large fraction of asymptomatic infections.

The team also investigated the infection status of household members, to estimate how likely an infected member is to pass on the infection within the household. Their modelling suggests that there was a probability of about 1 in 4 that a person infected with SARS-CoV-2 passes the infection to a family member and that 79% of transmission is caused by 20% of infections.

This confirms that there are large differences in the number of secondary cases generated by infected people. The large differences in how one infected person may infect others in the population suggest that behavioural factors are key for epidemic control. Physical distancing, as well as limiting the number of contacts and mask wearing, continue to be important to reduce the risk of transmitting the disease, even in highly vaccinated populations.

Teasing apart the impact of various control measures, the researchers showed that, in the absence of case isolation and short lockdowns, manual contact tracing alone would not have been enough to suppress the epidemic.

Blood test can track the evolution of coronavirus infection

Spanish researchers have shown a blood test that quantifies ACE2, the cellular protein which allows the SARS-CoV-2 virus to enter human cells, and ACE2 fragments produced as a result of interaction with the virus, could be an effective method for monitoring SARS-CoV-2 infection.

In a study carried out during the first wave of the pandemic, patients with COVID-19 who were in the acute phase of infection had significantly reduced blood levels of the full-length ACE2 protein, while levels of an ACE2 fragment, generated as a result of interaction with the virus, increased.

The abnormal levels of ACE2 and truncated ACE2 returned to normal after the patients recovered, suggesting these two forms of ACE2 could be used as a biomarker of the evolution of coronavirus infection. In addition, truncated ACE2 levels made it possible to distinguish between patients infected with SARS-CoV-2 and those with flu, the researchers say.

Threat of Delta variants sparks call to speed up COVID-19 vaccination in Europe

The latest assessment of the COVID-19 situation in the EU by the European Medicines Agency (EMA) and the European Centres for Disease Control (ECDC) shows the Delta variant (B.1.617.2), first identified in India, is spreading fast in Europe and may “seriously hamper” efforts to control the pandemic.

The evidence suggests Delta is 40% to 60% more transmissible than the earlier Alpha (Β.1.1.7) variant first identified in Kent, which drove the second wave of infection from December to May, and which was the first major variant of concern in the EU.

In addition, the Delta variant may be associated with higher risk of hospital admission, EMA and ECDC said in a joint update.

ECDC estimates that by the end of August the Delta variant will represent 90% of all SARS-CoV-2 viruses circulating in the EU.

Taken together, this makes it essential for countries to speed up vaccination programmes, including second doses, to prevent new infections and reduce the possibility of the further emergence of variants, the update says.

The risk of severe disease and mortality caused by COVID-19 is greater for older age groups and those with other underlying conditions. However, there are still 10 EU/EEA countries where nearly 30% or more of individuals older than 80 years have not yet completed the recommended vaccination course, according to ECDC’s Vaccine Tracker.

Further effort is also needed in some countries to increase vaccine uptake among health and social care workers.

The use of two different vaccines may allow populations to be protected more quickly and make better use of available vaccine supplies, but currently EMA and ECDC say they are not in a position to make any definitive recommendations on use of different COVID-19 vaccines for the two doses.

It’s also too early to confirm if and when a booster dose for COVID-19 vaccines will be needed.

Other measures such as mask wearing and social distancing will need to be maintained at a level sufficient to contain community transmission of the Delta variant until more of the populations are fully vaccinated, EMA and ECDC say.

Italian biotech ReiThera announces positive phase II data for its COVID-19 vaccine

ReiThera has published preliminary safety and immunogenicity data from the phase II clinical of GAd-COV2, its novel COVID-19 vaccine, showing it was well tolerated after the first, and even better after the second dose.

Antibody responses against the SARS-CoV-2 spike protein were achieved in over 93% of the volunteers at three weeks after the first dose, reaching 99% after the second dose. Five weeks after the first vaccination, levels of spike-binding and SARS-CoV-2 neutralising antibodies were comparable to that measured in a reference group of patients recovering from COVID-19 infection.

The study, conducted in 24 clinical centres in Italy, enrolled 917 volunteers over the age of 18, of whom 25% were over the age of 65 and/or had conditions associated with an increased risk of severe disease in case of SARS-CoV-2 infection. Volunteers were randomised to receive either a single vaccine dose followed by a placebo dose, or two vaccine doses, or two doses of placebo, with a three week interval between the two administrations.

“We are very excited about the preliminary phase II data,” said Roberto Camerini, Reithera’s medical director. “Our vaccine candidate confirmed its excellent safety and good immunogenicity profile in a large cohort.”

The phase III programme has approval from the European Medicines Agency and other regulatory agencies, and will start as soon as possible, Camerini said.

Commission hosts matchmaking event for COVID-19 therapies

Today and tomorrow, the Commission is hosting a pan-European matchmaking event to accelerate and scale up development and manufacturing of COVID-19 therapeutics in the EU, bringing together over 250 participants from across the value chain in 25 member states and other countries.

The event aims to increase the participation of companies in EU value chains for COVID-19 therapies, speed up connections between organisations and companies, and help in production planning.

It was kicked off by opening speeches by commissioners Thierry Breton and Stella Kyriakides.

“The EU is making good progress on vaccination, with 50% of adults now fully vaccinated. But vaccines are not our only response to COVID-19,” Kyriakides said. With the spread of variants and the resurgence of cases across the EU in recent weeks, the development of therapeutics is more necessary than ever. “I am encouraging companies to step forward and join forces to develop and produce COVID-19 therapeutics in the EU,” said Kyriakides.

The EU therapeutics strategy has identified five COVID-19 treatments and has set the target that three new drugs to treat the infection are approved by October 2021.

Breton, who is responsible for the internal market, said Europe has now produced and delivered enough doses of vaccine to vaccinate 70% of the adult population, becoming the world's biggest producer of mRNA vaccines. “This would not have been possible without new partnerships across the industrial ecosystem. We now want to forge new collaborations to ensure that Europe also leads the way in developing new life-saving COVID-19 treatments,” he said.

UK sets out post-Brexit strategy for life sciences based on success in developing and manufacturing COVID-19 vaccines

The response of the UK life sciences sector to COVID-19 will be used as a blueprint to accelerate development of drugs and devices for other diseases, as part of a ten year life sciences strategy published on Wednesday.

The strategy, co-developed with companies and experts in the field, outlines seven healthcare missions on which the government, industry, the National Health Service, academia and medical research charities will work together.

The missions will focus on preventing, diagnosing, monitoring and treating disease early, using novel clinical trial designs to develop products and treatments quickly, and ensuring rapid adoption of drugs, diagnostics, medical technology and digital tools.

In particular, the strategy looks to emulate the successes of the UK Vaccines Taskforce in harnessing private sector expertise and removing unnecessary bureaucracy so that healthcare challenges set out in the missions can be tackled at speed and at risk.

Amongst other objectives, the missions aim to accelerating the pace of studies into novel dementia treatments; sustain the UK’s position in vaccine discovery, development and manufacturing; promote development of treatments for cardiovascular diseases; reduce mortality and morbidity from respiratory diseases; and address the underlying biology of ageing.

Prime minister Boris Johnson said the seamless collaboration between scientists, industry, regulators and the NHS during the pandemic should become “the norm”.

Business minister Kwasi Kwarteng said the strategy sets out how to replicate the scientific excellence and agility seen in dealing with the pandemic in other health challenges, and “doing with cancer, dementia and obesity what we did with this virus – gaining the upper hand with brilliant science.”

To support the strategy, the government launched a Life Sciences Investment programme, with £200 million for venture capital firms to invest in growth companies. In addition, the government has a commitment from the Abu Dhabi sovereign wealth fund, the Mubadala Investment Company, to invest £800 million in the UK life sciences industry.

New research indicates individual variation in severity of infection needs more attention in COVID-19 clinical trials

A new modeling study suggests that significant variation in virus dynamics from person to person may be contributing to the inconsistent findings of clinical trials of COVID-19 antiviral drugs.

Recruiting trial participants shortly after symptoms begin could reduce the number needed to detect antiviral drug effects, according a study by US and Japanese researchers.

The conclusions are based on a model of the dynamics of the SARS-CoV-2 virus that causes COVID-19, once it has infected an individual. They combined the model with clinical data to examine how viral load in a person’s throat changes over time, and found significant variation in the rate of decline. These differences may contribute to the inconsistent results reported in non-randomised clinical trials so far, they say.

The researchers then simulated potential findings of randomised clinical trials for COVID-19 drugs that successfully interrupt virus replication. They found that, even a drug that that was so effective it reduced viral replication by 95%, a randomised clinical trial would need to enrol more than 26,000 people to detect statistically significant differences in viral load.

But when the researchers adjusted the simulated trials so participants were treated within one day of onset of their symptoms, only 1,200 participants were needed. They say future studies could employ more detailed models of SARS-CoV-2 dynamics, enabling better predictions of how many participants are needed to produce meaningful results.

Dutch researchers find sex and gender variables not accounted for in many COVID-19 clinical studies

Only 4% of studies investigating treatments for COVID-19 registered on the US site ClinicalTrials.gov explicitly report a plan to include sex and/or gender as an analytical variable.

This is despite the fact that sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. According to the researchers, the inclusion of sex as a variable could aid in the identification of effective interventions and provide insights into COVID-19 pathology.

Gender, as a socially constructed variable that can describe identity, norms and relations between individuals, can affect access to testing, diagnosis, medical care and treatments and also influences the availability of social, economic and logistical support.

Excluding sex differences in reporting results of clinical trials could lead to an increase in the risk of side effects for the excluded sex, while not addressing gender as a variable misses an opportunity to address healthcare inequality, say Sabine Oertelt-Prigione and colleagues, in research published in the journal Nature Communications.

They analysed the inclusion of sex and gender in COVID-19 studies registered on ClinicalTrials.gov (which in general includes all trials running in Europe and elsewhere, as well as the US) between 1 January 2020 and 26 January 2021. They identified 237 studies that planned sex-matched or representative samples, or emphasised sex and/or gender reporting, and 178 studies that reported a plan to include sex and/or gender as an analytical variable.

However, that was a drop in the ocean of 4,420 studies registered, the majority of which - 2,496 studies - did not refer to sex or gender, and 935 studies which mentioned sex or gender solely in the context of recruitment.

The researchers argue everyone working in COVID-19 and SARS-CoV-2 research should implement a sex-specific methodology and more comprehensive analysis, addressing gender-related impacts.

Scientists identify 160 drugs that could be repurposed against COVID-19

Cambridge University researchers have identified 200 approved drugs they predict will work against COVID-19, of which only 40 are currently being tested in COVID-19 clinical trials.

Using a combination of computational biology and machine learning, the researchers created a comprehensive map of the proteins that are involved in SARS-CoV-2 infection – ranging from proteins that help the virus enter the host cell, to those generated as a consequence of infection.

By examining this network using artificial intelligence (AI) approaches, they were able to identify key proteins involved in infection, as well as biological pathways that might be targeted by drugs.

Based on this, the team used computer modelling to carry out a virtual screen of almost 2,000 approved drugs and identified 200 approved products that could be effective against COVID-19. Forty of these drugs are in clinical trials, which the researchers argue supports the approach they have taken.

When the researchers tested a subset of those drugs implicated in viral replication, they found that two in particular - an antimalarial drug and a type of medicine used to treat rheumatoid arthritis - were able to inhibit the virus, providing initial validation of the data-driven approach.

Tony Kouzarides who led the study, said, "By looking across the board at the thousands of proteins that play some role in SARS-CoV-2 infection - whether actively or as a consequence of infections - we've been able to create a network uncovering the relationship between these proteins.

"We then used the latest machine learning and computer modelling techniques to identify 200 approved drugs that might help us treat COVID-19. Of these, 160 had not been linked to this infection before."

Of particular note were sulfasalazine, used to treat conditions such as rheumatoid arthritis and Crohn's disease, and proguanil, an antimalarial drug.

The study has provided unexpected information about the mechanisms underlying COVID-19 and pointed at drugs that might be repurposed for either treating or preventing infection. While the researchers took a data-driven approach, allowing AI to interrogate datasets, they validated the findings in the laboratory, confirming the power of this approach.

Large-scale analysis reveals potential new COVID-19 drugs

Researchers at the Francis Crick Institute, London and Dundee University have screened thousands of drugs, identifying a range of compounds with antiviral effects they say could be developed into treatments for COVID-19.

This would fill a big gap in the treatment of COVID-19, with very few drugs that can be used in the community to reduce symptoms and speed up recovery time. Therapies that act directly on the virus are especially needed by groups where the vaccines are less effective, for example, people with impaired immune systems.

In a series of seven papers, published in the Biochemical Journal, the scientists identified 15 compounds which inhibit the growth of SARS-CoV-2 by blocking different enzymes involved in its replication.

The researchers developed and ran tests for around 5,000 molecules to see if any blocked the function of any of seven SARS-CoV-2 enzymes. They then validated potential inhibitors against SARS-CoV-2 in the lab, to see if they slowed viral growth. The team found at least one inhibitor for each of the seven enzymes.

Three of the molecules identified are existing drugs used to treat other diseases. Lomeguatrib is used in melanoma and has few side-effects, suramin is a treatment for African sleeping sickness and river blindness and trifluperidol is used for mania and schizophrenia. As there is existing safety data on these drugs, it may be possible to more quickly develop them into SARS-CoV-2 antivirals.

John Diffley, lead author of the papers and associate research director at the Crick, said, "We've developed a chemical toolbox of information about potential new COVID-19 drugs. We hope this attracts attention from scientists with the drug development and clinical expertise needed to test these further."

The 15 molecules were also tested in combination with remdesivir, an antiviral being used to treat patients with COVID-19. Four of these, all which target the SARS-CoV-2 enzyme Nsp14 mRNA Cap methyltransferase, were found to improve the effectiveness of remdesivir in lab tests.

The scientists now plan to see if any pairs of the 15 molecules they identified inhibit the virus more than when they are used alone.

Targeting enzymes involved in virus replication could also help prepare for future viral pandemics, Diffley said. “Proteins on the outside of viruses evolve rapidly, but within different classes of viruses are well conserved proteins that change very little with time.”

Curevac’s phase III COVID vaccine results equivocal

German biotech announced results from the final analysis of its 40,000 subject international phase III study of its COVID-19 vaccine, CVnCoV, showing it was 48% effective at preventing infections.

That is lower than other vaccines that have been approved, but the company is stressing the trial was conducted in a different context, with 15 viral variants circulating within the study population at the time of final analysis.

In addition, there was a tougher endpoint than for other vaccines, which were assessed mostly on their ability to prevent serious disease and hospitalisation. Curevac on the other hand, assessed the ability of CVnCov to prevent COVID-19 disease of any severity, including single non-respiratory mild symptoms.

Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any severity, and across all 15 identified variants. At the same time, protection against moderate to severe disease was calculated to be 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death.

In participants above 60 years, who represented 9% of the analysed cases, the available data did not enable a statistically significant determination of efficacy. The data confirm the favourable safety profile of CVnCoV in all age groups. The data have been communicated to the European Medicines Agency.

“In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the age group of 18 to 60 against hospitalization or death and 77% against moderate and severe disease – an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic and the dynamic variant spread,” said Franz-Werner Haas, CEO of CureVac.

“In the current context of an increasingly diverse environment of COVID-19 variants, and with very little residual prevalence of the original strain, we are confident that the HERALD study offers clinically relevant data regarding the effect of emerging variants on vaccine efficacy.”

In total, 228 COVID-19 cases, 83 in people who received two doses of vaccines versus 145 in the placebo arm, were assessed in the final analysis. In the 18 to 60 age group vaccine efficacy against different variants ranged from approximately 42% to up to 67%.

COVID-19 infection changes the shape of blood cells in the long run

New research suggests that coronavirus infection alters the biomechanical properties of red and white blood cells, in some cases for months, and that this is a possible explanation for some symptoms of Long-COVID.

Scientists at the Max-Planck-Zentrum für Physik und Medizin in Erlangen were able to show for the first time that COVID-19 significantly changes the size and stiffness of red and white blood cells. They point to the shortness of breath, fatigue and headaches that some patients experience six months or more after being infected and suggest these are all phenomena in which the blood cells and their altered physical properties play a key role.

"We were able to detect clear and long-lasting changes in the cells, both during an acute infection and even afterwards," said co-author of the research, Jochen Guck.

The biophysicists examined more than four million blood cells, from 17 patients who were acutely ill with COVID-19, 14 people who had recovered and 24 healthy people as a control.

They found the size and deformability of red blood cells from patients with the disease were markedly different from those of healthy people. The damage to these cells could explain the increased risk of blood clots in hospitalised COVID-19 patients and long running symptoms afterwards.

Some of the changes observed persisted up to seven months after an acute infection.

Wind instruments less of a COVID-19 threat than singing or talking

The concentration of droplets in aerosols generated by blowing into woodwind and brass instruments was lower than in those produced when speaking and singing, and no different from a person breathing, according to new research by scientists at Bristol University.

The findings could help in developing a roadmap for lifting COVID-19 restrictions in the performing arts, which have been more or less shut down since the start of the pandemic.

The study looked at the amount of aerosols and droplets generated when playing woodwind and brass instruments compared with breathing, and speaking and singing. The work was carried out in an environment with no background aerosol particles to complicate measurement interpretation, with nine musicians playing 13 woodwind and brass instruments.

The research team found aerosols generated while playing the instruments were similar to that produced by breathing, based on several musicians playing the flute and piccolo, and measurements across a range of instruments including clarinet, trumpet, trombone, and tuba. Aerosol concentrations generated while instrument playing were lower than those associated with singing at high volume.

Large droplets were not observed during instrument playing, but were seen during singing and coughing. Together the findings indicate that playing woodwind and brass instruments generates fewer aerosols than vocalising at high volume.

Jonathan Reid, director of the Bristol Aerosol Research Centre, said the study confirms that the risks of transmission of SARS-CoV-2 are likely to be elevated during vocalisation at loud volume in poorly ventilated spaces.” By comparison, playing wind instruments, like breathing, generates fewer particles that could carry the virus than speaking or singing," he said.

Long COVID: Danish research shows reduced sense of taste and smell can last for up to 90 days

As the COVID-19 vaccines rollout in Europe prevents acute cases of infection, reducing hospitalisation and deaths, attention is turning to trying to prepare for the next stage of the pandemic, which will be in understanding and treating Long-COVID symptoms.

New research from Aarhus University, Aarhus University Hospital and Regional Hospital West Jutland, shows that even patients who experienced mild COVID-19 infections may have persistent symptoms.

In particular, 30% of participants in the study experienced a significantly long-lasting reduced sense of taste and smell.

The same was true for long-term shortness of breath, although in the case of this symptom relatively few people were affected.

While the vast majority of people who fall ill with COVID-19 experience mild symptoms and get over the disease in two to three weeks, emerging evidence indicates some symptoms – some of which are serious - may persist.

In the largest study yet, involving more than half a million people in England, 5.8% of participants had one or more symptoms following COVID-19 that persisted for 12 weeks or more. This would translate to two million-plus affected people for the population of England as a whole.

To date, most studies have looked at long term effects in people who were sick enough to be admitted to hospital. Community data are starting to put a new complexion on Long-COVID, both in terms of the disease burden and the stress it will put on health services.

In the Danish study, researchers compared symptoms every day, for up to 90 days, in 210 healthcare workers who had tested positive for COVID-19, and 630 with a negative test. Each day, participants received a questionnaire on whether they had experienced one of the following symptoms within the last 24 hours: coughing, sore throat, headaches, fever, muscle pain, shortness of breath and reduced sense of taste and smell.

"We saw that the prevalence of a longer-lasting reduced taste and smell is significantly increased in patients with mild COVID-19 disease who did not require hospitalisation. This pattern is also seen for shortness of breath, but far fewer people were affected," says Henrik Kolstad, an author of the study.

Thirty per cent of those who had tested positive reported a reduced sense of taste and smell for the full ninety days. At the beginning of the project, shortness of breath was reported by twenty per cent of those who had tested positive. That fell to 5% after thirty days, but did not fall as low as in participants who had tested negative.

Coughing, sore throat, headaches, muscle pain and fever were more common among those who tested positive than those who tested negative over the first few days, but had stopped by day 30.

Worse outcomes observed after heart attacks during pandemic compared to previous year

Heart attacks that occurred during the COVID-19 pandemic were more likely to result in heart failure compared with heart attacks one year earlier, according to research presented this week at the European Society of Cardiology in Sophia Antipolis, France.

"Heart attack patients waited an average of 14 hours to get help during the pandemic, with some delaying for nearly two days. That compares to a delay of six hours in the previous year," said study author Ali Aldujeli of the Lithuanian University of Health Sciences, Kaunas. "This gap may have been one contributor to the higher incidence of subsequent heart failure."

Fast treatment of heart attacks is essential to restore the flow of oxygen-rich blood to the heart muscle. A longer duration of oxygen deprivation is associated with a greater area of damaged muscle and a reduction in pumping function.

The retrospective, multicentre study covered six out of ten regions in Lithuania, with a total of 269 heart attack patients evaluated in the retrospective study. There was a 34.0% decline in heart attack admissions during the early phase of the pandemic compared to the same period in 2019. Patients waited significantly longer before presenting to hospital during the pandemic compared to 2019 (a median of 858 versus 386 minutes, respectively).

Aldujeli said the decline in admissions and delays in seeking treatment may be partly attributed to the extensive media coverage which “amplified patients' fear of contracting COVID-19” and “precluded them from seeking timely medical care.”

Outcomes differed according to type of heart attack, and that may have been influenced by new pandemic-specific protocols that were implemented to prevent spread of the virus, Aldujeli said. "Our findings suggest that all heart attacks during a pandemic should be treated urgently with staff using personal protective equipment. More balanced media coverage is also needed so that patients do not wait to seek help in medical emergencies."

Commission identifies five promising COVID-19 drugs

The EU strategy on COVID-19 therapeutics has delivered its first outcome, with the announcement of the first portfolio of five drugs, which could be made available to treat patients across the EU.

Four of these are monoclonal antibodies currently under rolling review by the European Medicines Agency, the other is an approved immunosuppressant, for which the label could be extended to include treatment of COVID-19 patients.

Commissioner for health Stella Kyriakides, said, “Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. Whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19.”

The five drugs that have been selected are at an advanced stage of development and could be approved by October 2021, the target set under the strategy.

Overall, the Commission will draw up a portfolio of at least 10 potential COVID-19 drugs by October, building on the work of a newly-established expert group on COVID-19 virus variants. The selection process will be objective and science based, with selection criteria agreed with the member states.

Global biotech sector pushes back on COVID-19 vaccines IP

CEOs of global biotechnology companies and associations from across Europe and the US have hit out against the waiver of intellectual property rights proposed in the World Trade Organisation, saying it will be ineffective and counterproductive in addressing the pandemic.

Intellectual property rights are not responsible for the imbalance in COVID vaccine supplies between higher and lower income countries, and the waiver will create a long, contentious global negotiation that will not address the crisis, they say. Rather, it will foster more “vaccine nationalism,” and exacerbate shortages in an already strained global supply chain.

“It would divert limited resources from companies that are focused on maximising current global partnerships, while maintaining quality and patient safety,” the CEOs say.

The waiver would also send a signal to the biotech sector and investors to avoid taking the risks involved in developing vaccines, diagnostics and treatments in future public health emergencies, the CEOs said.

“Intellectual property is the foundation of our sector. It is responsible for creating the global biotech network that responded so quickly to the COVID crisis in the first place. It is what gives investors the confidence to fund companies with long time horizons and high risks.”

Intellectual property rights gave companies the assurance that they could quickly pivot during the early days of the pandemic, and to move into COVID projects.

Based on these efforts, current estimates are that existing global vaccine manufacturers will produce more than 11 billion doses of COVID vaccines in 2021, and significantly more in the first part of 2022. “We are committed to working with other global stakeholders to see that these doses get to those that most need them, wherever they may be,” the CEOs say.

New study shows how to get orchestras playing again

Strategically rearranging the seats of orchestra musicians and altering the airflow in concert venues could dramatically reduce concentrations of COVID-19-spreading aerosols that accumulate on stage during performances, according to a new simulation-based study.

Performing artists’ careers and livelihoods across the piece have been greatly impacted by the pandemic, with many unable to practice their craft. However, few studies have investigated exactly how the virus might be transmitted in this context, including in large spaces such as concert hall stages.

To better understand how wind instruments might contribute to the spread of infectious aerosols during on-stage performances, researchers at the University of Utah used information about the flow rates of different instruments to simulate airflow and the spread of fine aerosols for two Utah concert venues, the Abravanel Hall and Capitol Theatre.

The researchers assessed possible COVID-19 exposure and risk of infection for musicians on stage (not audience members) and simulated how rearranging the players, altering airflow patterns in the venue by opening doors, or adding structural enhancements to redirect airflow, could better protect the performers.

For Abravanel Hall they found emissions accumulation could be reduced by placing non-wind instruments (piano and percussion) at the centre of the stage, situating bassoons, which project aerosols high into the air, near the doors, and arranging other instruments close to air vents.

Since there was little airflow around musicians in the Capitol Theatre and nothing to recirculate air, the researchers modelled the construction of an airflow passageway over the back doors, showing that created stronger airflow behind the performers.

With hayfever season in full swing, researchers show tree pollen carries SARS-CoV-2 aloft, promoting virus spread

A study on the role of microscopic particles in transmitting COVID-19 suggests pollen is nothing to sneeze at, according to researchers who have investigated how pollen facilitates the spread of viruses like SARS-CoV-2.

The study was sparked when the researchers noticed a correlation between COVID-19 infection rates and pollen concentrations on the US National Allergy Map.

They used computational methods for analysing fluid dynamics to mimic pollen movement from a willow tree, showing airborne pollen grains contribute to the spread of airborne viruses, especially in crowded environments.

Trees can release up to 1,500 grains per cubic metre into the air, depending on the time of year and the weather. Each pollen grain can carry hundreds of virus particles at a time.

"To our knowledge, this is the first time we show through modelling and simulation how airborne pollen micrograins are transported in a light breeze, contributing to airborne virus transmission in crowds outdoors," the researchers said.

The researchers started by modelling the pollen production of their computational willow tree. They then simulated outdoor gatherings of 10 or 100 people, some of them shedding COVID-19 particles, and subjected them to 10,000 pollen grains.

Tuning the model to the temperature, wind speed and humidity of a typical spring day in the US, the pollen passed through the crowd in less than one minute. The researchers say that could significantly affect the virus load carried along by the breeze and increase the risk of infection.

Given this, the two metres often cited for COVID-19 social distancing might not be adequate for those at risk for the disease to be protected in crowded areas with high pollen levels.

Study of how SAR-CoV-2 takes human cells hostage leads to potential drugs against COVID-19

Researchers from the German Centre for Infection Research at Charité-Universitätsmedizin Berlin and the University of Bonn who have investigated how SARS-CoV-2 reprogrammes the metabolism of human cells, have identified four substances which inhibit SARS-CoV-2 replication in host cells.

These are: spermine and spermidine, substances naturally found in the body; MK-2206, an experimental cancer drug; and niclosamide, which is used to treat tapeworm.

Charité is now conducting a trial to assess if niclosamide is effective against COVID-19 in humans.

The team of researchers, led by Marcel Müller of Charité's Institute of Virology, and Nils Gassen of the Psychiatry and Psychotherapy Clinic at the University Hospital Bonn, found SARS-CoV-2 slows down the cell's own recycling mechanism, a process known as autophagy, through which cells dispose of damaged materials and waste products, whilst recycling reusable products into new cellular structures.

"In our study, we were able to show that at the same time as using the cell's building blocks for its own benefit, SARS-CoV-2 deceives the cell by simulating a nutrient-rich status, thereby slowing cellular recycling,” Gassen said.

The same reprogramming strategy is also used by the MERS coronavirus, whose autophagy-inhibiting action the researchers elucidated more than a year ago.

When results suggested autophagy pathways might be a potential target for COVID-19 therapies, the researchers tested whether substances which induce cellular recycling also block replication of SARS-CoV-2 inside infected cells.

The four potential drugs they discovered include spermidine, an autophagy-enhancing metabolite which is produced in all human cells and by bacteria in the human gut. It occurs naturally in foods such as wheat germ, soya, mushrooms, and mature cheese. When the researchers added spermidine to cells infected with SARS-CoV-2, there was an 85% reduction in the number of virus particles produced.

Similar results were produced by spermine, which also occurs naturally in the body. This was found to reduce viral replication by more than 90% in human lung cells and in a human gut model.

The third substance to prove effective against SARS-CoV-2, MK-2206, is currently in clinical trials against a range of different cancers. In the COVID-19 study, the drug reduced production of SARS-CoV-2 virus by approximately 90%.

The most pronounced antiviral effect was associated with niclosamide, which reduced production of SARS-CoV-2 particles by more than 99 percent. "Niclosamide showed the strongest effect in our cell culture-based experiments. What is more, it has been licensed for use against tapeworm infections in humans for a very long time and is well tolerated at potentially relevant doses,” said Müller.

"Out of the four new candidate substances, we consider it to be the most promising one. This is why we are now conducting a clinical trial at Charité to test whether niclosamide might also have a positive effect on people with COVID-19,” Muller said. “[This] shows how quickly findings from basic research can reach patients if research and clinical practice are closely interlinked and work together in an efficient manner."

COVID-19 can lead to long term cognitive and behavioural problems

COVID-19 patients are suffering from cognitive and other problems as long as two months after being discharged from hospital, with many experiencing deficits in memory, spatial awareness and information processing, according to a study conducted in Italy.

One in five patients reported post-traumatic stress disorder (PTSD), with 16% having symptoms of depression.

The study involved testing neurocognitive abilities and taking MRI brain scans of patients two months after COVID-19 symptoms had cleared. More than 50% of patients experienced cognitive disturbances; 16% had problems with memory, flexible thinking and information processing; 6% experienced difficulties judging depth and seeing contrast; and 25% manifested a combination of all these symptoms.

Cognitive and psychopathological problems were much worse in younger people, with the majority of patients aged under 50 demonstrating issues with these executive functions.

Across the whole sample, greater severity of COVID-19 acute respiratory symptoms during hospital admission was associated with low executive function performance subsequently.

Ten months post-COVID-19, the cohort showed a reduction of cognitive disturbances, from 53% to 36%, but a PTSD and depressive symptoms persisted.

Massimo Filippi of the Scientific Institute and University Vita-Salute San Raffaele, Milan, who led the research, said, "Our study has confirmed significant cognitive and behavioural problems are associated with COVID-19 and persist several months after remission of the disease. A particularly alarming finding is the changes to executive function we found, which can make it difficult for people to concentrate, plan, think flexibly and remember things. These symptoms affected three in four younger patients who were of a working age."

Larger studies and longer-term follow up are both needed, but this study suggests that COVID-19 is associated with significant cognitive and psychopathological problems. Patients should be followed-up and treated to ensure they are given adequate support to help alleviate these symptoms.

The research was presented at European Academy of Neurology meeting in Vienna on Monday.

Scientists create cellular model of how COVID-19 infects the lungs

A team led by researchers at Newcastle University has successfully derived a model of the cells found in the lungs, which they say can be used to replicate how COVID-19 infects the airways.

This paves the way for broader studies of viral lung infections, using a cost-effective system that can easily be manufactured on a large scale.

The researchers used induced pluripotent stem cells to generate airway epithelial cells, culturing them on a polyester membrane to allow formation of a single layer, and then exposing them to an air/liquid interface that induce the cells to differentiate into a stratified epithelial model.

Irish scientists identify how and why some Covid-19 patients develop life-threatening blood clots

While previous research has shown blood clotting is a significant cause of death in patients with COVID-19, it was not known why this happens.

Now, scientists have analysed blood samples from patients with COVID-19 treated in intensive care at a hospital in Dublin, finding the balance between a molecule that causes clotting, called von Willebrand Factor (VWF), and another molecule, ADAMTS13 that regulates it, are severely disrupted.

The discovery could lead to targeted therapies to prevent this from happening, the researchers say.

When compared to control groups, the blood of COVID-19 patients had higher levels of the pro-clotting VWF and lower levels of the anti-clotting ADAMTS13. Furthermore, the researchers identified other changes in proteins that caused the reduction of ADAMTS13.

"Our research helps provide insights into the mechanisms that cause severe blood clots in patients with COVID-19, which is critical to developing more effective treatments," said one of the researchers, Jamie O'Sullivan, of the Irish Centre for Vascular Biology in Dublin.

"While more research is needed to determine whether targets aimed at correcting the levels of ADAMTS13 and VWF may be a successful therapeutic intervention, it is important that we continue to develop therapies for patients with COVID-19,” O’Sullivan said. “COVID-19 vaccines will continue to be unavailable to many people throughout the world, and it is important that we provide effective treatments to them, and to those with breakthrough infections.”

Curevac’s COVID-19 vaccine fails phase III interim analysis

The COVID-19 vaccine under development by German biotech CureVac is only 47% effective in preventing infections of the SARS-CoV-2 virus, according to an interim analysis of the phase III trial involving 40,000 volunteers.

The company said the failure to meet the pre-specified target for effectiveness was a result of a high number of variants of the virus circulating in the areas where the trial took place. While the vaccine, CVnCoV was designed against the original wild type of the virus that emerged in Wuhan, China, volunteers in the study were infected with a least 13 different variants.

A total of 57% of the infections were caused by the variants of concern, which have also been having an impact on the effectiveness of the approved vaccines.

Curevac said CVnCoV had a good safety profile and the trial will go through to the final analysis.

The interim analysis involved 134 cases of COVID-19 infection. Of these, the DNA of 124 viruses was sequenced and only one case was caused by the original Wuhan strain.

“We will continue the study,” said Franz-Werner Haas, CEO of Curevac. “The final efficacy may change.”

Vaccines are effective against Delta variant of SARS-CoV-2

With the World Health Organisation warning the Delta variant of the Sars-CoV-2 virus first detected in India is poised to take hold in Europe, there is positive news, indicating vaccines remain effective.

A new analysis by Public Health England (PHE) shows two doses of either Pfizer/BioNTech’s or Astrazeneca’s COVID-19 vaccines are preventing people infected with the Delta variant becoming seriously ill and needing to be admitted to hospital.

According to the date the Pfizer/BioNTech vaccine is 96% effective against hospitalisation after two doses, while the AstraZeneca vaccine is 92% effective against hospitalisation after two doses.

These are comparable with vaccine effectiveness against hospitalisation from the Alpha variant that first emerged in Kent in December and rapidly spread around Europe.

Further work remains underway to establish the level of protection the vaccines provide against mortality from the Delta variant.

The analysis included 14,019 cases of the Delta variant, 166 of whom were hospitalised, between 12 April and 4 June, looking at emergency hospital admissions in England.

PHE has previously published analysis showing that one dose is 17% less effective at preventing symptomatic illness from the Delta variant, compared to Alpha, underlining the importance of ensuring people are fully vaccinated.

German researchers find COVID-19 can cause severe inflammation in the brain

A team of researchers at the Freiburg University Medical Centre has shown a severe inflammatory response can develop in the central nervous system of COVID-19 patients, involving different immune cells around the vascular system and in the brain tissue.

“Even though there was already evidence of central nervous system involvement in COVID-19, the extent of inflammation in the brain surprised us," said Henrike Salié co-author of the research published in the journal Immunity.

Notably, the researchers detected structures called microglial nodules that are not found in healthy brains.

Using a novel measurement method, the researchers were able to image different cell types, including virus-infected cells, and to view spatial interactions of cells, in previously unseen detail.

"Until now, the inflammatory pattern in COVID-19 was poorly understood. Even compared to other inflammatory brain diseases, the inflammatory responses triggered by COVID-19 are unique and indicate a severe disturbance of the brain's immune response,” said Marco Prinz, medical director at the Institute of Neuropathology.

“In particular, the essential defence cells of the brain, microglial cells, are [very] strongly activated,” Prinz said. There was also pronounced neuroinflammation in the brain stem.

The immune changes are easiest to pick up in small blood vessels in the brain where the ACE2 receptor by which the virus enters human cells is expressed. Here, the virus was directly detectable. The researchers suggest that the immune system responds to these infected cells, sparking inflammation that then spreads to the nerve tissue, causing symptoms.

It is possible that early immunomodulatory or immunosuppressive treatment could reduce inflammation, they say.

COVID-19 vaccines trials continue to increase, as therapies tail off

After COVID-19 was officially declared a pandemic by the World Health Organisation (WHO), the peak in total number of clinical trials investigating therapies for the virus was 445, in April 2020.

There has since been a steady decrease in new clinical trials in every month, apart from December 2020 and March 2021, according to market research firm GlobalData.

There has been a divergence between therapies and vaccines, with the number of COVID-19 vaccines trials continuing to increase throughout the pandemic. The number peaked in March 2021 at 89 trials.

At the beginning of the pandemic there was a surge in trials of potential therapeutics in the scramble to find treatments for the infection. But once vaccines began to be approved, trials of therapies began to decline.

“The upward trend for vaccine COVID-19 clinical trials is expected to continue due to the same approved vaccines [being] tested against new variants of the virus,” said Scotty Chung-Siu, senior analyst at GlobalData. “On the other hand, the decrease in therapeutic COVID-19 clinical trials may be due to the increase in availability of vaccines, as well as the negative data in clinical trials from some therapeutics.”

COVID-19 vaccines IP ‘has to be protected’ says von der Leyen

The European Commission is making a push to expand access to COVID-19 vaccines in low and middle income incomes countries, whilst resisting the call to over-ride patents other countries, including the US, have called for.

In a speech to the European Parliament, setting out the position she will put to the G7 meeting taking place in the UK this coming weekend, Commission president Ursula von der Leyen said, “I want to be very clear: I think intellectual property has to be protected because it is the idea behind the breakthrough, and it retains the incentives for innovation in research and development.”

Rather than compulsory licensing, as called for by the World Trade Organisation (WTO), von der Leyen said voluntary licences are the most effective way to support local production of vaccines.

But she said, there is a “big however”. In a global emergency like this, “If voluntary licencing fails, compulsory licensing has to be, and is, the legitimate tool to scale up production,” von der Leyen said.

As von der Leyen noted, vaccine production requires not only patents but highly trained staff. “These are very complicated biological processes. They require know-how, they require technology, they require skilled personnel and, of course, infrastructure,” she said.

Simply waiving intellectual property rights will not increase production. “It is actually by collaboration and, if need be, compulsory licensing that you enhance technology transfer,” von der Leyen said.

But patents should not stand in the way, which is why Europe had started an initiative in WTO to simplify compulsory licensing, said von der Leyen.

In addition, the EU has committed €1 billion to help set up vaccine manufacturing hubs in Africa. The G7 meeting will provide a good opportunity to reaffirm the EU’s commitments “and to go even further,” von der Leyen said.

G7 agrees clinical trials charter for pandemic vaccines

G7 health ministers committed to a new international agreement designed to make it easier and quicker to share results from vaccine and therapeutic trials to tackle COVID-19 and prevent future health threats.

The Therapeutics and Vaccines Clinical Trials charter will help deliver high quality, reliable and comparable evidence from international clinical trials, to speed up access to approved treatments and vaccines.

During the COVID-19 pandemic some of the rapidly organised clinical trials played a critical role in informing public health and clinical decisions, but many other studies were inadequate in size, design and how they were conducted, failing to generate reliable evidence.

More effective international collaboration on trials would have made better use of scarce resources and may have saved lives. An assessment by the US Food and Drug Administration suggests only about a quarter of enrolled patients contributed to adequately powered and well controlled trials.

While vaccine development has been faster in the pandemic than ever before, improvements can be made. For example, the use of different laboratory testing methods and reagents meant it was often not possible to compare immune responses directly; a lack of pre-agreed processes was a barrier to the cross-border movement of materials; and there was no overall coordination of trial testing methodology.

The G7 charter pledges to avoid the proliferation of trials that do not contribute valid evidence, prioritising support for randomised controlled trials. This will be taken this forward through national healthcare and research systems, with ministers agreeing to promote communication and coordination between them.

To avoid unnecessary duplication in future the G7 will coordinate emergency and preparedness research agendas, for example, sharing vaccines and therapeutics national research agendas and sharing information on ongoing and planned trials.

Scientists find first evidence of a genetic link to explain why some people who catch COVID-19 don't become sick

A team led by researchers at Newcastle University has demonstrated that the gene HLA-DR1 is found three times more often in people who have a confirmed COVID-19 infection but don’t have any symptoms, suggesting the gene confers some level of protection from severe infection.

HLA-DR1 is known to be involved in the body’s immune response to infections and the researchers believe this is the first clear evidence of inbuilt genetic resistance to the worst effects of COVID-19.

Carlos Echevarria from the Translational and Clinical Research Institute at Newcastle University who is a respiratory consultant at Newcastle Hospital said, "This is an important finding as it may explain why some people catch COVID but don't get sick.”

It could lead to a genetic test to help in prioritising those most at risk when designing vaccination programmes. Knowing who has this natural genetic resistance would also be important for other control measures.

"At a population level, this is important for us to know because when we have lots of people who are resistant, so they catch COVID but don't show symptoms, then they risk spreading the virus while asymptomatic," Echevarria said.

The study used samples from 49 patients with severe COVID-19 who had been hospitalised with respiratory failure, samples from an asymptomatic group of 69 hospital workers who had tested positive, and a historic control group.

Silver lining: research shows the pandemic drastically curbed urban crime

Daily crime counts before and after COVID-19 restrictions were implemented in major metropolitan areas such as Barcelona and London show that while stringency of lockdowns varied considerably from city to city, most types of crime fell significantly.

Overall, stricter lockdowns led to greater declines in crime, but even cities with voluntary "recommendations" instead of restrictions, such as Malmo and Stockholm in Sweden, saw drops in daily rates of theft, according to the study led by researchers at the universities of Cambridge and Utrecht.

Across 27 cities worldwide, daily assaults fell by an average of 35%, robberies involving violence or intimidation almost halved, falling an average of 46%, and other types of theft, from pick pocketing to shoplifting, fell an average of 47%.

Theft of vehicles fell by an average of 39% over the study sites. Researchers found that tougher restrictions on use of buses and trains during lockdowns was linked to greater falls in vehicle theft - suggesting that negotiating cities via public transport is often a prerequisite for stealing a car.

In Barcelona there were massive falls in the number of assaults (84% drop) and robberies (80% drop). Thefts reported to police in the city declined from an average of 385 per day, to just 38 per day under lockdown.

London saw less pronounced, but still significant falls in some crime, with daily robberies dropping by 60%, theft by 44% and burglaries by 29%.

"City living has been dramatically curtailed by COVID-19, and crime is a big part of city life," said Manuel Eisner, director of the Violence Research Centre at Cambridge University, who is senior author of the study published in Nature Human Behaviour.

"No drinkers spilling into the streets after nights out at bars and pubs. No days spent in shops and cafés, or at the racetrack or football match. Some cities even introduced curfews. It choked the opportunism that fuels so much urban crime,” said Eisner.

The one exception was the number of murders committed, with a fall of just 14% on average across all cities in the study. Criminologist Amy Nivette, assistant professor at Utrecht University said, "In many societies, a significant proportion of murders are committed in the home. The restrictions on urban mobility may have little effect on domestic murders.”

Falls in crime resulting from COVID-19 stay-at-home orders tended to be sharp but short-lived, with a maximum drop occurring around two to five weeks after implementation, followed by a gradual return to previous levels.

"The measures taken by governments across the world to control COVID-19 provided a series of natural experiments, with major changes in routines, daily encounters and use of public space over entire populations,” Eisner said. "The pandemic has been devastating, but there are also opportunities to better understand social processes, including those involved in causing city-wide crime levels."

COVID-19 pandemic driving development of antimicrobial resistance

The largest analysis to date shows that unnecessary use of antibiotics to treat patients with serious COVID-19 could be fuelling bacterial resistance.

The research found that antibiotic use was very high in hospitalised COVID-19 patients in the UK during the first wave of the pandemic, despite confirmed bacterial infections being uncommon.

Of 46,000 patients in the study, 85% received one or more antibiotics when in hospital, while 37% of patients were prescribed antibiotics prior to admission. In the event, only 1,017 of the patients had a confirmed bacterial infection.

The researchers believe the high level of antibiotic use in the UK is likely to be replicated elsewhere, meaning the COVID-19 pandemic could undermine international efforts to preserve the effectiveness of antimicrobial drugs.

The overuse of antibiotics during the first wave, in February to May 2020, is attributed to the fact that there was little knowledge of COVID-19 and how to treat it. Other viral respiratory infections, notably influenza, are strongly associated with bacterial co-infections, leading clinicians to treat COVID-19 patients with antibiotics on a just-in-case basis.

Currently, national and international COVID-19 guidelines vary in their recommendations on such empirical antibiotic use. UK guidelines have now been updated to advise against antibiotics in COVID-19, without specific evidence of bacterial infection.

In the UK study, very few patients had bacterial co-infections when first admitted to hospital, and the few infections that did occur began more than 48 hours after admission.

These secondary infections were not specific to COVID-19, but more in keeping with the usual run of hospital-acquired infections, particularly those typically seen in intensive care units.

“Until now, a detailed understanding of the nature of bacterial co-infections identified in patients with COVID-19, and the frequency and types of antibiotics these patients have been prescribed has been lacking,” said Antonia Ho of Glasgow University’s Centre for Virus Research, who led the study.

“This study demonstrates the very high antibiotic use we see in hospitalised COVID-19 patients may not be necessary, indeed it may contribute to antimicrobial resistance,” she said

Some COVID-19 patients will require antibiotics, mostly for secondary infections which develop after admission to hospital, but not all COVID-19 patients should be prescribed antibiotics. “The bugs we identified are similar to those found in patients with hospital-acquired infection, and not specific to COVID-19,” Ho said.

WHO announces simpler names for SARS-CoV-2 variants

The World Health Organisation has come up with a new naming system for key variants of SARS-CoV-2 virus that it says are easier to say and remember.

Rather than a single letter followed by a string of numbers, as in B.1.1.7, also known as the Kent variant; the South African variant B.1.351; the Indian variant, B.1.617; and the Brazil variant P1, WHO recommends using letters of the Greek alphabet.

The Kent variant becomes alpha, South African delta, Brazilian gamma and the Indian variant delta.

These labels were chosen after wide consultation and a review of many potential naming systems. WHO convened partners from around the world including experts who are part of existing naming systems, nomenclature and virus taxonomic experts, researchers and national authorities.

WHO will assign labels for viral variants that are designated as variants of interest or variants of concern, because it is thought they could be more transmissible and/or more virulent.

The labels do not replace the existing scientific names, which convey important scientific information and will continue to be used in research. But while they have their advantages, WHO says these scientific names can be difficult to say and recall, and are prone to misreporting.

As a result, people often resort to calling variants by the places where they are first detected. That is “stigmatising and discriminatory” WHO said. To avoid this and to simplify public communications, WHO encourages adoption of the new labels.

ECDC makes recommendations on COVID-19 vaccination of adolescents

The European Centre for Disease Prevention and Control (ECDC) adopted a technical report on COVID-19 vaccination of adolescents, setting out key elements to take into account when considering whether or not to vaccinate this age group.

This follows a European Medicines Agency decision last week that the Pfizer/BioNTech vaccine is safe for use in 12 – 15 year olds.

ECDC is now following up with “practical evidence based considerations” to support member states that are considering expanding national vaccination programmes to adolescents, said health commissioner Stella Kyriakides.

Such vaccinations should be considered in the broader context of the COVID-19 vaccination strategy for the whole population, ECDC says.

The vaccination of adolescents at high risk of severe COVID-19 should be considered a priority, as with other age groups.

The design and implementation of adolescent vaccination is a national responsibility, and member states are now in a position to start using the vaccine for 12-15 year olds should they decide to do so, the Commission said.

Danish invention preserves muscle mass in COVID-19 patients

Researchers from Aarhus University have developed electronic support stockings and tested them on COVID-19 patients at Copenhagen University Hospitals, showing the stockings significantly counteracted the loss of muscle mass typically seen in people who are confined to bed.

The Aarhus researchers developed a biocompatible electrode for electrical muscle stimulation that was 3D-printed onto the medical support stockings. These were tested on consenting patients who were in hospital with COVID-19 infection in the winter 2020/2021.

The participants , who were hospitalised for five to seven days wore a support stocking on each leg, only one of which had the printed electrodes, meaning patients acted as their own control.

Participants' thigh muscles were electrically stimulated for 30 minutes, twice a day, at an individually adapted intensity.

"The study demonstrated that these patients lost approximately 10% of their muscle mass after just five to six days of hospitalisation,” said Charlotte Suetta, chief physician and lead investigator in the clinical trial. “However, with this new technology we've been able to counteract the loss,” Suetta said.

Muscle loss is a serious problem for hospitalised patients, especially those that need intensive care and are on ventilators for long periods. Recovering from muscle loss after several weeks of total inactivity may take months or years, and some people never recover fully.

While there is nothing new about electrical stimulation of muscles, there are several disadvantages with existing products including difficulties in getting electrodes on and off, and skin irritation in the stimulated areas.

"Our invention is much easier to use because the electrodes are an integral part of the textile," said Shweta Agarwala, an expert in printed electronics.

The electrodes have three ultra-thin, flexible layers, and these can be printed directly onto different types of material, making it possible to stimulate the muscles through the stocking with minimal irritation. “Since the electrodes are an integral part of the stockings, they can also tolerate hospital cleaning processes,” Agarwala said.

To date, Aarhus University has printed almost 600 support stockings for medical use. It is likely the stockings can be used for a far larger group than just COVID-19 patients, including bedridden patients in general, as well as in rehabilitation and for wheelchair users.

Oxford University launches £500M pandemic sciences centre

A new pandemic sciences centre is being set up at Oxford University to build on global research collaborations developed over the past 40 years, with the aim of ensuring that the world is better equipped to prepare for, identify, and counter future pandemic threats.

The university is now looking to raise over £500 million to invest in this centre

The centre, which will include a number of core institutes, will also harness the collaborations that have developed in record time across national borders between academia, industry and public health bodies, during the current coronavirus pandemic.

The pandemic has demonstrated the contributions research universities can make to pandemic preparedness, said Louise Richardson, Oxford’s vice chancellor. “We are building on decades of medical research on infectious disease and data science, we have longstanding international partnerships and we have the ability to act and to adapt quickly.”

Within the university, the centre will draw together academics and experts including from infectious diseases, vaccinology, immunology, structural biology, diagnostics, drug discovery, clinical trials, data science, public health, and social and political sciences.

The inaugural director of the centre will be Peter Horby, professor of emerging infectious diseases, who is leader of the UK-wide Recovery clinical trial, which has tested a number of different drugs in the treatment of COVID-19 infections. The Recovery trial demonstrated the steroid dexamethasone is an effective treatment for severe disease, while showing the malaria drug hydroxychloroquine is not.

“The COVID-19 pandemic has shown us that spectacular advances are possible through an alliance of science, the public sector and industry – creating digital disease control tools, diagnostic tests, and life-saving treatments and vaccines at unprecedented speed,” Horby said. “But it should not take a pandemic to make this happen. This level of innovation and multi-sectoral collaboration must be applied, day in and day out, to prevent another catastrophe like COVID-19.”

GSK secures US emergency approval for anti-COVID-19 antibody

GlaxoSmithKline and its US partner Vir Biotechnology said the US. Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for sotrovimab, an antibody drug for treating mild to moderate COVID-19 in adults and children aged 12 and older, who are at high risk for progression to severe COVID-19, including hospitalisation or death.

The latest analysis of clinical trial data showed sotrovimab resulted in an 85% reduction in all-cause hospitalisations or death, while in vitro studies show it retains activity against all known variants of concern, including the variant of the virus from India

The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the phase III trial in high risk adult outpatients, which was stopped early by an independent data monitoring committee in March 2021 because of the evidence of profound clinical efficacy.

Sotrovimab targets a conserved part of the viral spike protein that is less likely to mutate over time. The EUA submission also included data from in vitro studies, which demonstrated that sotrovimab maintains activity against all known circulating variants of concern, including the variants from Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the UK (B.1.1.7).

On 21 May 2021, the European Medicines Agency issued a positive scientific opinion for sotrovimab, and the agency has started a rolling review of data on the drug that will continue until enough evidence is available to support the filing of a formal marketing authorisation application.

Sanofi and GSK start phase III trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline plc said they started enrolment in a phase III clinical study to assess the safety, efficacy and immunogenicity of their COVID-19 vaccine.

The study will include more than 35,000 volunteers aged 18 and older from several countries, including the US, Asia, Africa and Latin America.

If the phase III is positive, the vaccine could be approved in Q4 2021. Manufacturing will begin in the coming weeks to enable rapid access to the vaccine should regulators approve.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in people who have not previously been exposed to the infection, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection.

In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus that emerged in Wuhan, China, while a second stage will evaluate a second formulation targeting the South African variant. Recent evidence indicates antibodies created against this variant may provide broad cross-protection against other more transmissible variants.

The design of the phase III study also allows evaluation of the efficacy of the vaccine against a variety of circulating variants.

Following encouraging interim results from the recent phase II study, the companies will also begin clinical studies in the coming weeks to assess the ability of their vaccine to generate a strong booster response regardless of the initial vaccine received.

“We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting,” said Thomas Triomphe, head of Sanofi Pasteur. “This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.”

The phase III study follows the interim phase II results which showed that the COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups,

This trial has received funding from the US Biomedical Advanced Research and Development Authority.

EU moves to defuse COVID-19 vaccines patents row

The EU is come forward with a proposal in the World Trade Organisation (WTO) clarifying and facilitating the use of compulsory licencing of vaccines patents in crisis times like the COVID-19 pandemic.

The commitment was made at the global health summit of G20 leaders, co-hosted on 21 May by the European Commission and Italy, and convened to share lessons learned from the COVID-19 pandemic.

Speaking after the meeting, Commission president Ursula von der Leyen said the global community acknowledges intellectual property is an instrument to boost vaccines manufacturing capacity and the G20 is committed to working on this within the existing Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the 2001 Doha declaration, which sets out the terms on which governments can take compulsory licenses.

“Of course, voluntary licensing is the best way to ensure the necessary transfer of technology and know-how together with the IP rights. The existing TRIPS Agreement and the 2001 Doha declaration already today foresee compulsory licensing, as a perfectly legitimate tool for governments to use in a crisis. This has been reconfirmed today by the G20,” von der Leyen said.

However, developing countries are complaining about “how difficult” it is to use these flexibilities, and in response the EU will come forward with a proposal in the WTO “to offer a third way,” said von der Leyen. This will focus on three components, she said. “Trade facilitation and disciplines on export restrictions; support for the expansion of production; on IP, clarifying and simplifying the use of compulsory licenses in crisis times like this pandemic, where necessary.”

Global Pandemic Radar to set up network of hubs to identify emerging COVID-19 variants

The World Health Organisation (WHO) and the UK medical research charity Wellcome Trust are to lead on setting up a Global Pandemic Radar to identify emerging COVID-19 variants and track new diseases around the world.

The aim of the pathogen surveillance network is to spot emerging COVID-19 variants and other infectious diseases before they cause pandemics and enable the rapid development of vaccines, treatments and diagnostics.

WHO will lead an implementation group, supported by the Wellcome Trust, to launch this new international partnership to identify, track and share data on new coronavirus variants and monitor vaccine resistance in populations.

Tedros Adhanom Ghebreyesus, director general of WHO said, “The COVID-19 pandemic underscores the vital need for a robust, modern system to keep the world ahead of emerging diseases through active monitoring at the community level, swift and accurate sequencing of new pathogens, and data-sharing across the globe.”

The pandemic radar will build on existing surveillance mechanisms and data sharing agreements for HIV, TB and malaria. “This pandemic has provided a stark wake-up call to the threat posed by a fast-moving infectious disease,” said Jeremy Farrar, director of the Wellcome Trust. “We are long overdue the essential reinforcement of our local, national and international disease surveillance networks.”

Change in storage conditions set to ease distribution of Pfizer/BioNTech vaccine

The European Medicines Agency has approved a change to the storage conditions for the Pfizer/BioNTech COVID-19 vaccine that is at the centre of the EU’s vaccination rollout, making the product easier to distribute and administer.

Currently, the vaccine must be kept at ultra-low temperatures, which requires specialised fridges. Once thawed it can be kept for five days in a conventional fridge. The change means it will now be possible to store the thawed, undiluted COVID-19 vaccine at fridge temperatures of 2°C to 8°C, for 31 days.

Within the 31 days, transport of the thawed, undiluted vials is permitted for a maximum of 12 hours in total. The shelf life of the vaccine once it is diluted for administration has not changed. It is stable for six hours at 2-30°C from the point of dilution and must be administered within this time.

The extended storage period is effective immediately and accounts for all currently available and future batches.

The change in the storage conditions is based on new data from stability studies that confirmed product quality for 31 days. The formulation of the vaccine remains unchanged.

Pfizer and BioNTech have submitted a request for the same change to the US Food and Drug Administration and plan to submit to other regulators.

BerGenBio’s repurposed cancer drug effective in severe COVID-19

Norwegian biotech BerGenBio said the phase II trial of its cancer drug bemcentinib in the treatment of COVID-19 infections showed it increased the rate of ventilator-free survival in the 50%-plus of hospitalised patients who had the most severe infections.

In total, 90% of this sub group of bemcentinib treated patients survived without the need for mechanical ventilation, versus 72% of patients who received standard of care.

The trial was conducted from October 2020 across multiple sites in South Africa and India, with 115 patients enrolled at the end of March 2021. The data from this phase II builds on two other studies conducted in the UK.

Patients treated with bemcentinib appeared to be protected from an early deterioration at day 2 or 3, compared to patients treated with standard of care, which included steroids and in some cases the antiviral drug remdesivir. This effect was maintained through to 29 days.

The primary endpoint of time to improvement by two grades from baseline, or time to discharge or fitness for discharge, marginally favoured bemcentinib treatment over standard of care, but the difference was not statistically significant.

In the two UK studies, combining the data showed overall survival to day 29 was 96.5% (83 of 86 evaluable patients) in the bemcentinib arm versus 91% (81 of 89) treated with standard of care alone.

BerGenBio said taken overall, the data clearly points to a benefit in treating a substantial subset of hospitalised COVID-19 patients. Bemcentinib has the advantage over other cancer drugs that are being repurposed for treating COVID-19 that it is administered as a one per day tablet.

The data will support ongoing engagement with regulatory agencies, governments and industry on how to take bemcentinib development forward, the company said.

Stener Kvinnsland, director of BerGenBio said, “The greatest challenge faced by hospitals worldwide is an unmanageable demand for [intensive care unit] capacity and ventilator support for COVID-19 patients. For the foreseeable future, in spite of recent progress with vaccinations, there remains a substantial global need for effective treatments for COVID-19 patients that offers survival benefit and relief for intensive care demand on hospitals.”

Sanofi/GSK COVID-19 vaccine now due by end of 2021

Partners Sanofi and GlaxoSmithKline say they are on track to get approval of their COVID-19 vaccine before the end of the year, after reporting positive results from a phase II trial.

The vaccine was initially expected to be approved in the first half of 2021, but the companies had to go back to the drawing board after an earlier phase II that reported last December found there was an insufficient immune response in people aged 50 and over.

In the latest trial, involving 722 volunteers, the product achieved strong rates of neutralising antibody responses after two doses, in line with those measured in people who have recovered from COVID-19. A phase III study is expected to start in the coming weeks.

After a single injection, high neutralising antibody levels were generated in those volunteers who had recovered from a natural SARS-CoV-2 infection, suggesting there is potential to develop the vaccine for use as an immune booster.

"Our phase II data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge, and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” said Thomas Triomphe, head of Sanofi Pasteur. “We are set to progress to a global phase III efficacy study.”

The phase III trial is expected to enrol more than 35,000 participants in a number of countries and will assess the efficacy of two formulations, against the original virus that emerged in China and the B.1.351 South African variant that has shown some resistance to first generation COVID-19 vaccines.

In parallel, the companies intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine received.

The clinical studies to date have been financed by the US Biomedical Advanced Research and Development Authority.

EU agrees list of mutually approved rapid tests for COVID-19

The EU Health Security Committee (HSC) has agreed to update the common list of COVID-19 rapid antigen tests, easing the way for the EU’s single digital vaccine certificate to allow foreign travel.

Following the update, 83 tests are now included in the common list, of which the results of 35 tests are mutually recognised by all member states.

Commissioner for health, Stella Kyriakides, said, “Rapid antigen tests play a crucial role to slow down the spread of COVID-19. Having a wider list of recognised rapid antigen tests will make it easier for citizens to benefit from digital green certificates and to facilitate safe free movement inside the EU in the coming months.”

In addition, the Commission and the Joint Research Centre have agreed a new procedure for updating the list of common and mutually recognised tests in the future. In future, there will be a common procedure for carrying out independent validation studies to assess the clinical performance of rapid tests.

Commission launches COVID-19 therapeutics strategy

The European Commission launched a strategy to support development of, and access to, COVID-19 therapies, including for the treatment of people who have recovered from the acute phase of infection but are now suffering from long COVID.

The strategy, intended to parallel the EU’s efforts in COVID-19 vaccines, is targeting approval of three new treatments for COVID-19 by October 2021, and possibly two more by end of the year. On the back of this, the Commission says it will launch new contracts for the purchase of authorised drugs by the end of the year.

A total of €90 million will be invested in population studies and clinical trials to look for links between risk factors and health outcomes, to further inform public health policy and clinical management, including for long COVID patients.

By July, the Commission will set up a therapies innovation ‘booster’ to support the most promising products through from preclinical research to market authorisation. This will build on current initiatives and investments in drug development, working in a close cooperation with the new European Health Emergency Preparedness and Response Authority, to ensure the coordination of all research projects on COVID-19 therapies.

A further €5 million is to be invested under the EU4Health programme to generate better safety data in clinical trials, to help produce robust results in a timely manner.

EU member states will be eligible for €2 million under EU4Health in 2021, to carry out expedited and coordinated assessments of applications to conduct clinical trials.

In addition, there will be a horizon scanning programme, with €5 million to map therapies and diagnostics and analyse what phase of development they are at, and the production capacities and supply chains. That will inform the establishment of a broader portfolio of ten potential COVID-19 therapies, with the five most promising identified by June 2021.

The Commission is keen not to make the same mistake in therapeutics as it did in vaccines, where despite large advance purchase agreements, there was no support for manufacturing. In this case, it is putting in €40 million to support flexible manufacturing and access to COVID-19 drugs.

EMA starts rolling review of antibody against COVID-19

The European Medicines Agency said it started a rolling review of a monoclonal antibody developed by GlaxoSmithKline and US biotech Vir Biotechnology for the treatment of COVID-19.

The decision to conduct the accelerated review is based on preliminary results from an ongoing study looking at the ability of the drug, sotrovimab, to prevent hospitalisation or death in patients with COVID-19 being treated in the community.

That would fill a gap in the care pathway, because currently there are no therapies specifically approved for patients at high risk of developing severe COVID-19 who are being treated at home.

Rolling reviews involve looking at data as they become available from ongoing studies, before a formal application is submitted. EMA said while the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation.

A separate EMA review of sotrovimab is underway to provide EU-wide recommendations to support national authorities in case they want to use the drug prior to marketing authorisation.

Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19, reducing the ability of the virus to enter the body’s cells. Preclinical data suggest it has the potential to both block viral entry into healthy cells and to clear infected cells.

The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the phase III study, which is evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

In March, the independent safety board monitoring the trial recommended it should stop enrolling more patients because there was already evidence of efficacy. Enrolled patients continue to be followed up.

Von der Leyen says EU will discuss IPR waiver on COVID-19 vaccines

European Commission president Ursula von der Leyen said EU is ready to discuss any proposal that addresses the pandemic crisis in an effective and pragmatic manner, including over-riding patents. “That is why we are ready to discuss how the US proposal for a waiver on intellectual property protection for COVID-19 vaccines could help achieve that objective,” she said in a speech this morning to the State of the Union conference at the European University Institute.

That follows a decision by the US to support the waiver, with US trade commissioner Katherine Tai saying on Wednesday, “The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in [World Trade Organisation] negotiations to make that happen.”

Von der Leyen’s change in tone is at odds with the European Parliament, which voted against the waiver on 29 April 2021.

European pharma companies joined counterparts elsewhere in the world in condemning the move, with Nathalie Moll, director general of the industry body EFPIA saying, “This short-sighted and ineffectual decision by the Biden administration puts the hard-won progress in fighting this terrible disease in jeopardy. While we wholeheartedly agree with the goal of protecting citizens around the world through vaccines, waiving patents will make winning the fight against the coronavirus even harder.”

Moll said increasing capacity to deliver doses to citizens around the world requires the skills and technical know-how of the vaccine developer to bring on-board partner manufacturing organisations. “You simply cannot achieve this kind of capacity expansion by waiving patents and hoping that hitherto unknown factories around the world will turn their hand to the complex process of vaccine manufacture,” she said.

A waiver also risks diverting raw materials and supplies away from well established supply chains to less efficient manufacturing sites and opens the door to counterfeit vaccines entering the supply chain around the world, Moll said.

Pharma hits out at US move to override COVID-19 vaccines patents

The decision of the US administration to support a patent waiver for COVID-19 vaccines is “disappointing”, according to a statement from pharma companies.

“We are fully aligned with the goal to ensure COVID-19 vaccines are quickly and equitably shared around the world. But, as we have consistently stated, a waiver is the simple - but the wrong answer - to what is a complex problem,” the statement says.

Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle the global health crisis. On the contrary, it is likely to lead to disruption, while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally, the industry says.

Pharma companies hit back after the general council of the World Trade Organisation (WTO) agreed to allow the Council for Trade-Related Aspects of Intellectual Property Rights to continue consideration of the proposal first put forward by India and South Africa for a temporary waiver of certain intellectual property obligations in response to COVID-19.

The waiver had the support of 60 WTO members, but the one that is likely to swing things is the US. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines,” said US trade representative Katherine Tai in a statement announcing the US had changed its position.

The industry squarely aims at trade barriers it says are holding up supply chains. Another problem that would not be solved by waiving intellectual property rights is shortages of raw materials and other essential items, such as glass vials and filters used in bioprocess of bulk materials.

Demand continues to outstrip supply, but the industry says there should be “willingness” by rich countries to start sharing doses with poor countries.

“We will continue to leave no stone unturned to further scale up manufacturing of COVID-19 vaccines, as no one is safe until everyone is safe,” the statement says.

Companies have voluntarily agreed more than 200 technology transfer agreements to expand delivery of COVID-19 vaccines based on “unprecedented” partnerships, companies say.

Israel national study shows Pfizer/BioNTech COVID-19 vaccine gives high level protection in real world

Two doses of the Pfizer/BioNTech COVID-19 vaccine provide more than 95% protection against infection, hospitalisation, severe illness, and death, including among the elderly, according to the first national real world assessment of its effectiveness, carried out in Israel,

The study, published in The Lancet, unpicks for the first time the public health benefits of a national vaccination programme. Vaccination was found to be the key driver of a decline in COVID-19 infections in Israel.

The findings are encouraging, but unknowns, notably the duration of immunity to COVID-19 remain. It is also possible that new, vaccine resistant variants could emerge in the future, the authors say.

Lead author, Sharon Alroy-Preis, of the Israel Ministry of Health, said that as the country with the highest proportion of its population vaccinated against COVID-19, Israel provides a unique real-world opportunity to determine the effectiveness of the vaccine. “Until this point, no country in the world had described the national public health impact of a nationwide COVID-19 vaccination campaign. These insights are hugely important because, while there are still some considerable challenges to overcome, they offer real hope that COVID-19 vaccination will eventually enable us to control the pandemic.”

Vaccination with the Pfizer/BioNTech vaccine began amid a surge of infections that led to a national lockdown in Israel on 27th December 2020. Daily infections peaked at 10,213 cases on 20 January 2021, and lockdown was lifted on 7 March 2021.

By 3 April 2021, 72% or 4,714,932 people over 16 years, and 90%, or 1,015,620, of those over 65 years, had received two doses of the Pfizer/BioNTech vaccine.

During the analysis period, there were 232,268 confirmed COVID-19 infections in the country. The most prevalent strain was B.1.1.7, first detected in the UK, which accounted for 94.5% (8,006 of 8,472) of samples tested through Israel’s PCR testing service.

The Pfizer/BioNTech vaccine was highly effective against COVID-19 for all people over the age of 16 years, providing 95.3% protection against infection and 96∙7% protection against death seven days after the second dose. The vaccine is also highly effective in preventing hospitalisation.

Assessing efficacy after one dose of Pfizer/BioNTech vaccine demonstrated the importance of fully vaccinating adults. Protection was considerably lower between seven and 14 days after receiving the first dose, compared to two doses.

Clinical trials are resuming but pandemic still impacting enrollment

The surge in new variants of COVID-19 and an increase in subsequent cases is continuing to have an impact on clinical trials, even though studies are resuming. The total number of disrupted trials has levelled off and the number of clinical trials that have restarted continues to rise, but at a somewhat slower rate than the initial rise.

This implies that sponsors and contract service providers have begun to adjust clinical trial design strategies and are adapting to the new post-COVID-19 environment, according to GlobalData, a data and analytics company.

“Since June 2020, the number of total disrupted trials has been falling slowly; however, this levelled off in October 2020. The majority of current trial disruptions are due to trials impacted by slow enrollment, said Brooke Wilson, associate director, trials intelligence at GlobalData.

Trials that started enrolling before the pandemic, with sites and investigators chosen, but then were suspended due to COVID-19, are “having more success picking up where they left off,” Wilson said.

But overall, the number of trials being impacted by slow enrollment continues to increase.

Methods that could help start or sustain research include virtual visits, phone interviews, self-administration, and remote monitoring. These suggestions could help trials that are being hampered by quarantines, travel limitations, clinical site closures, and interrupted supply chains, especially trials that delayed initiation and trials that are experiencing slow enrollment.

Study of global response to COVID-19 sets out plan to overhaul vaccines R&D

A new report uses lessons learned from the rapid development of COVID-19 vaccines to explore opportunities to overhaul R&D in the field, saying nothing in recent times has underlined the value of investing in basic research as much as the speedy development of effective vaccines.

COVID-19 vaccines are also a testament to the power of partnerships to break down institutional and competitive barriers to scientific collaboration, says the report by the high level Sabin-Aspen vaccine science & policy group. Such success can only become routine if there is a specific effort to bring people together across disciplines, to drive novel research.

To promote this convergence there should be support for a research infrastructure that creates opportunities for novel approaches and risk taking and leverages lessons from adjacent scientific areas, ranging from the chemistry and physics of vaccine formulation, to the immunological basis of protection.

In addition, clinical design is ripe for more efficient and nimbler approaches. Bringing together large datasets and analyses of clinical and laboratory information on infected and vaccinated individuals may make it possible to identify what level of immune response is needed to confer protection, allowing regulatory approval to be based on smaller and faster trials. The use of master protocols could accelerate trials and make it easier to compare the results of one study with those of another, the report says.

The effort to improve vaccine discovery and development and must be accompanied by updated regulatory science and processes, with streamlined preclinical testing, faster, nimbler and more cost-effective trials, and enhanced product scale-up and manufacturing, the group says.

Denmark bans J&J single dose COVID-19 vaccine, putting back vaccination rollout by 4 weeks

The Danish Health Authority (DHA) said it would not use Johnson & Johnson’s single dose COVID-19 vaccine, following an evaluation by the European Medicines Agency which concluded there is a possible link between rare but severe cases of blood clots and the vaccine.

DHA said the COVID-19 epidemic in Denmark is currently under control and the vaccination rollout is progressing satisfactorily using other vaccines. As a result, it has decided the benefits of using the Johnson & Johnson vaccine do not outweigh the risk of causing serious blood clots.

The decision does mean there will be a four week delay in vaccinating people aged 20 – 39.

“In the midst of an epidemic, this has been a difficult decision to make, especially since we have also had to discontinue using the COVID-19 vaccine from AstraZeneca,” said DHA deputy director general, Helene Probst.

“Taking the present situation in Denmark into account, what we are currently losing in our effort to prevent severe illness from COVID-19 cannot outweigh the risk of causing possible side effects in the form of severe blood clots in those we vaccinate,” Probst said.

Denmark’s national vaccination rollout began more than four months ago and almost everyone in the most vulnerable group of people aged over 65 has been invited, has booked, or has begun the vaccination process.

The decision to continue the rollout without the COVID-19 vaccine from Johnson & Johnson will affect those between 20 and 39 years old, who are facing a delay of up to four weeks.

“Age is the main risk factor for severe illness from COVID-19, and these are younger citizens who are not at risk of becoming seriously ill," said Probst.

EMA assessing use of Pfizer/BioNTechCOVID-19 vaccine in adolescents

The European Medicines Agency said it has started evaluating an application to extend the use of the Pfizer/BioNtech COVID-19 vaccine to include young people aged 12 to 15.

The agency will carry out an accelerated assessment, including results from a large ongoing clinical study involving adolescents from 12 years of age. The evaluation is expected to be completed in June.

Separately, EMA announced it has begun a rolling review of a COVID-19 vaccine developed by the Chinese pharma company, Sinovac Life Sciences. The vaccine contains inactivated SARS-CoV-2 virus, plus an adjuvant that is intended to strengthen the immune response.

The vaccine has been evaluated in four clinical trials conducted in China and overseas, involving 14,572 participants.

New research shows how the pandemic hit entrepreneurs and what policies are needed to support recovery

An EU-funded study of how entrepreneurs have survived the COVID-19 pandemic, shows most faced significant challenges that threatened the survival of their businesses, but there was resilience in how they navigated the crisis, by being agile, adaptive, exploring new opportunities and using government support.

The study, carried out by researchers at King’s College London, involved surveying over 5,000 entrepreneurs in 23 countries that represent 75% of the world’s economic output. The findings paint a picture of opportunities, but also vulnerabilities of these SME entrepreneurs in the COVID-19 pandemic.

While entrepreneurs were in general optimistic and could see an upside to the pandemic, including long-term positive impacts on their businesses and job creation, it was also clear that many face real challenges to sustain their businesses going forward and that the pandemic is taking a toll on their mental health.

Building on the insights from the survey, the researchers identify five trends and highlight policy actions to support SMEs and entrepreneurs for a thriving post-COVID economy. During the pandemic, most governments were focussed on relief measures, including financial support. This was taken up by SMEs and entrepreneurs when available.

With vaccine programmes being rolled out, policy focus should now shift to how the economic recovery can be aided, the researchers say.

Preprints are speeding up dissemination of COVID-19 research and the process of science

A new piece of research shows that during the pandemic scientists have made increasing the use of preprints to publish their research and these papers are being read more frequently.

This has prompted a cultural shift in how preprints are used and viewed, with the media and the public taking far more interest, according to Jonathon Alexis Coates of Queen Mary University of London, a co author of the paper.

Preprints are free to read, often updated, and most importantly, enable researchers to share their research when it is complete, rather than having to submit to a journal and await acceptance – or rejection – and peer review.

Apart from open access, a benefit is that the process of science is speeding up. Preprints are typically posted within two days of being submitted to a server, in contrast to the months or years that it can take for research to go through peer review, Coates says.

Although many journal publishers have prioritised COVID-19 research and taken down paywalls, on average it still takes 34 times longer for a paper to be published in a journal rather than posting it on a preprint server, which takes 24 - 48 hours).

According to the research, during the first ten months of the pandemic, more than 25% of COVID-19 publications, or 30,260 papers, first appeared as preprints. (That includes this particular paper, which has now appeared in a peer review journal, after earlier being published as a preprint).

COVID-19 preprints were viewed 18.2 times and downloaded 27.1 times more than non-COVID preprints posted during the same ten-months.

COVID-19 preprints are also being used to directly influence policymaking decisions. The World Health Organisation and the European Centre for Disease Control have cited preprints in policy documents during the pandemic. Coates says that in similar policy documents from before COVID-19, preprints don’t appear to have been widely referred to before.

Danish researchers find recipe for success in lockdown home working

COVID-19 broke the mould of the 9 – 5 day in the office overnight. There have since been many analyses of people’s experiences when they were forced to work from home during lockdown, and now researchers in Denmark have drawn on this to devise a tool that can be used to systematically identify pros and cons when drawing up home working policies.

The researchers, at DTU Management in Lyngby, Denmark, identified six areas they say managers should focus on when developing strategies for remote work in future.

“We’ve examined the pros and cons of working from home among managers and employees in knowledge jobs in eight European countries,” said Christine Ipsen, associate professor at DTU (Technical University of Denmark), who is one of the researchers behind the study.

The tool is based on answers to questionnaires in the eight European countries, completed by people who worked from home during the lockdown from mid-March to mid-May 2020.

“Most people felt that working from home provided benefits in terms of better work/life balance, increased efficiency, and more control over their own work. These three advantages outweighed the three main disadvantages: the inevitable shortcomings of the home office, the greater uncertainty when you don’t meet physically with your boss and colleagues, and finally the reduced access to necessary work tools that are normally available in the office,” Ipsen said.

But it’s not a given that everyone feels positive about working from home. “By analysing employees’ experiences based on the six factors we identified, management can get an overview of what to keep in mind, and when to take action in relation to different employee groups,” said Ipsen.

The researchers found that young people aged 18 to 30 scored higher when it came to work/life balance than employees over the age of 31. On the other hand, young people had more problems with uncertainty about the work compared to older generations, who perceived inadequate tools as a bigger problem.

“It’s about minimising the disadvantages, because the trend we’re seeing shows that people will work more from home in the future, even when [COVID-19] no longer dominates society,” Ipsen said.

Experiences of remote work may change in the future, Ipsen noted. “More studies are needed to look at the six factors over time and in more industries,” she said.

Europe to improve monitoring of COVID-19 vaccines

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) kicked off a new initiative aimed at strengthening monitoring of the safety, effectiveness and impact of COVID-19 vaccines.

With the ongoing authorisation and rollout of several COVID-19 vaccines in the EU, jointly coordinated, large-scale, EU-wide effectiveness and safety studies are an essential tool to see how novel vaccines perform in real life, according to the two agencies. These studies will generate evidence to support continuous assessment of the benefits and risks of the vaccines and inform decision making on their use in national or regional vaccination strategies.

The move comes after EMA was criticised by member states for not providing explicit advice on the use of AstraZeneca’s and Johnson & Johnson’s vaccines, following its review of rare cases of unusual blood clots. EMA concluded the clots are a rare side effect of the vaccines, but said it was up to national governments to decide how to shape vaccines rollout in response to this finding.

EMA and ECDC will jointly coordinate and oversee a number of observational studies funded from the EU budget and conducted in several European countries. EMA will lead on monitoring safety and ECDC on the effectiveness of vaccines.

This work will be supported by a joint advisory board (JAB) to the two agencies.

“Observational research is an important pillar in the post-marketing surveillance of COVID-19 vaccines and increased EU level collaboration is needed so that member states can join forces and organise large studies that meet the needs of both medicines regulators and national institutes for public health and vaccination,” said Emer Cooke, EMA’s executive director.

“This new model of collaboration brings medicine regulators and public health authorities closer together and establishes processes towards a more permanent, sustainable collaboration platform for monitoring vaccine safety and effectiveness,” said Andrea Ammon, ECDC director.

Europe takes another step towards COVID-19 vaccine tech sovereignty and self sufficiency

Pharmaceuticals ingredient manufacturer Evonik said it has delivered the first lipids from its facility in Hanau, Germany, to BioNTech, for the manufacture of the Pfizer/BioNTech COVID-19 vaccine.

The delivery is months earlier than planned, with specialists at the Hanau site setting up the lipid production in just eight weeks. Initially, delivery was scheduled to start in the middle of the year.

"Setting up production at this speed is a great achievement," said Christian Kullmann, chair of Evonik. "Increasing lipid production in Germany will also allow us to further accelerate the manufacturing of larger quantities of the vaccine."

Initial manufacture of the Pfizer/BioNTech vaccine at Pfizer’s plant in Belgium relied on imports of lipids from a manufacturer in the UK, and the head of the EU’s vaccines taskforce Thierry Breton, competition commissioner, has been working to increase EU autonomy and end-to-end control of vaccines supply chains.

As part of its strategic partnership with BioNTech, Evonik produces two different lipids for the Pfizer-BioNTech COVID-19 vaccine. Together with other lipids, they encapsulate to form a lipid nanoparticle, which works as a protective shell around the messenger RNA that carries the genetic code for the spike protein of the virus. Once injected, the mRNA is released to allow the vaccine to take effect.

"This is a complex production process that only a few in the world master," said Thomas Riermeier, head of Evonik's health care business.

EMA beats US counterpart in review of rare blood clots seen with Johnson & Johnson COVID-19 vaccine

The European Medicines Agency (EMA) has concluded there is a possible link between Johnson & Johnson’s single dose COVID-19 vaccine and eight cases of unusual blood clots seen in people who received the vaccine in the US, but said the benefits of vaccination outweigh the risks.

A warning about the rare clots will be added to the label and listed as a very rare side effect of the vaccine.

EMA looked at all the currently available evidence, which consisted of eight reports of the clots occurring among over seven million people who had received Johnson & Johnson’s vaccine in the US, as of 13 April.

Following the reports, use of the vaccine was put on hold in the US and Johnson & Johnson said it would be delaying rollout in Europe, telling member state governments to put supplies into storage.

Following a meeting on 14 April the US Food and Drug Administration and the Centers for Disease Control, jointly decided they needed more time to deliberate and extended the hold. They are expected to announce a decision on Friday (23 April).

EMA said it was able to conclude its review sooner because of its experience in looking at similar rare clots that have been seen in people who received the AstraZeneca vaccine.

It is possible to treat the rare clots, EMA said. Now the warning is on the label and healthcare providers and the public have been alerted to the symptoms, it will be up to member states to decide on the rollout of the Johnson & Johnson vaccine. That decision should be based on the level of infection, the number of people in hospital and intensive care, and the availability of other vaccines, EMA said.

“EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual member states,” the agency said.

UK government launches partnership to prevent another global pandemic

The UK government has set up a pandemic preparedness partnership to advise the G7 group of nations on how to harness international collaboration to intensify research and development, modernise clinical trials and improve vaccines manufacturing and supply chains.

The partnership, meeting formally for the first time today, will be backed by £16 million in additional funding from the UK government to support the work of the Coalition for Epidemic Preparedness Innovations (CEPI) on global vaccine supply.

The public private partnership, chaired by UK government chief scientific adviser Patrick Vallance, brings together industry, international organisations and leading experts. It will provide recommendations for delivering on targets to more quickly develop vaccines, therapeutics and diagnostics, through greater global cooperation on research and development, manufacturing, clinical trials and data sharing.

The partnership will report to leaders at the G7 summit, to be held in Cornwall in June, which the UK is hosting as current president of the G7.

The £16 million investment in CEPI will fund global vaccine manufacturing capacity and R&D to rapidly respond to the threat of new variants of SARS-Cov-2, supporting the development of variant-specific vaccines.

The aim is to have millions of doses of a vaccine available for emergency use by 100 days after a variant of concern is identified.

“COVID-19 has shown us that it’s possible to develop and deploy high quality vaccines much faster than previously imagined,” Vallance said. “We have brought together the pandemic preparedness partnership to see whether this can be accelerated even further and applied to the development of medicines and diagnostic tests.

German researchers show COVID-19 mutation from mink reduces effect of antibodies in humans

SARS-CoV-2, the virus that causes COVID-19, can mutate in mink in a way that reduces immune control by antibodies, according to new research carried out at the German Primate Centre at the Leibniz Institute for Primate Research in Göttingen.

The research shows that an antibody used in an approved COVID-19 therapy is unable to effectively inhibit SARS-CoV-2 harbouring a spike mutation acquired in mink and that the mutation also reduces the effect of neutralising antibodies produced in people following infection with SARS-CoV-2.

It has been known for about a year that mink can become infected with SARS-CoV-2 and that the virus had been transmitted from humans to farmed mink and has mutated in infected animals.

Mutations were acquired in the spike protein, via which the virus enters human cells, with these SARS-CoV-2 variants then being transmitted back to humans, raising concerns that mink could be a continuing source of infection of humans.

As a result, in June 2020 the Danish government ordered a mass cull of 15 million farmed mink to prevent the transmission of new viral variants to humans. Other European governments have also ordered control measures.

Researchers at the German Primate Centre looked at a number of mutations found in the spike protein in farmed mink, including Y453F. “Our results show that one of two antibodies from an antibody cocktail used for COVID-19 therapy no longer efficiently inhibits the viral variant with the Y453F mutation,” said researcher Markus Hoffman.

“Furthermore, our study demonstrates that the Y453F mutation reduces inhibition of the virus by antibodies produced by COVID-19 patients. This means that people who were infected with SARS-CoV-2 may have reduced protection against mink variants of the virus", Hoffman said.

Risk of rare blood clots higher after COVID-19 infection, than after COVID-19 vaccination

Researchers at Oxford University have reported the risk of rare blood clots (cerebral venous thrombosis, CVT) following COVID-19 infection is around 100 times greater than normal and several times higher than the risk after vaccination, or following a bout of influenza.

Paul Harrison, professor of psychiatry at Oxford University, who led the research, said, “There are concerns about possible associations between vaccines and CVT, causing governments and regulators to restrict the use of certain vaccines. Yet, one key question remained unknown: ‘What is the risk of CVT following a diagnosis of COVID-19?’”

“We’ve reached two important conclusions. Firstly, COVID-19 markedly increases the risk of CVT, adding to the list of blood clotting problems this infection causes. Secondly, the COVID-19 risk is higher than seen with the current vaccines, even for those under 30; something that should be taken into account when considering the balances between risks and benefits for vaccination,” Harrison said.

The researchers counted CVT cases diagnosed in the two weeks following diagnosis of COVID-19, or after the first dose of a COVID-19 vaccine. They then compared these to the incidence of CVT following influenza, and to the background level in the general population.

They found CVT is more common after COVID-19 than in any of the comparison groups, and that 30% of these cases occurred in people under 30 years of age. The risk compared to current COVID-19 vaccines is between 8-10 times higher, and compared to the normal background level, approximately 100 times higher.

In the study of over 500,000 COVID-19 patients, CVT occurred in 39 in one million patients.
In over 480,000 people who received a COVID-19 mRNA vaccine (Pfizer or Moderna), CVT occurred in 4 in one million.
CVT has been reported to occur in about 5 in one million people after first dose of the AstraZeneca COVID-19 vaccine.
Compared to the mRNA vaccines, the risk of a CVT from COVID-19 is about 10 times greater.
Compared to the AstraZeneca, the risk of a CVT from COVID-19 is about 8 times greater.

However, all comparisons must be interpreted cautiously since data are still accruing.

Commission begins negotiation for further 1.8B doses of Pfizer/Biontech vaccine

Negotiations have begun on a third advance purchase agreement for 1.8 billion doses of the Pfizer/BioNTech COVID-19 vaccine, with the European Commission stipulating that manufacturing of the product and all the components that go into it must be based in the EU.

The doses will be delivered from 2021 to 2023. Commission president Ursula von der Leyen announced the negotiations as the EU reached the milestone of administering 100 million vaccinations. Of these, more than a quarter were second doses.

To date, member states have received a total of 126 million doses of vaccine, and after a stuttering start, vaccination rates are picking up. But another delay is looming, with rollout of Johnson & Johnson’s vaccine now on hold pending investigation into unusual blood clots in six people who received the product in the US.

This comes on top of holds in a number of member states on using AstraZeneca’s vaccine, also put in place as a result of concerns about of blood clots that the European Medicines Agency said is a rare side effect.

“As we can see with the announcement by Johnson & Johnson yesterday, there are still many factors that can disrupt the planned delivery schedule of vaccines,” von der Leyen said.

To try and fill this gap, the Commission has also agreed with Pfizer/BioNTech that 50 million doses that were due in the third quarter of 2021 will now be delivered in Q2. This will bring the total doses delivered by Pfizer to 250 million doses in the second quarter. These will be distributed pro-rata to the population, among all the member states.

US pauses use of Johnson & Johnson COVID-19 vaccine after reports of blood clots

The US Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have called a temporary halt to the use of Johnson & Johnson’s COVID-19 vaccine while they conduct a review, following six reports of rare blood clots.

CDC said it will convene a meeting of its Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance, with FDA subsequently reviewing that analysis.

As of April 12, more than 6.8 million doses of the single shot Johnson & Johnson vaccine have been administered in the US.

The six blood clots are similar to those seen with AstraZeneca’s vaccine in Europe. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the joint CDC/FDA statement said.

EMA starts two further investigations into COVID-19 vaccines safety

After concluding that very rare blood clotting events are linked to the AstraZeneca COVID-19 vaccine, the EMA safety committee has now started a review of reports of blood clots in people who have received the Johnson & Johnson vaccine.

Four serious cases of unusual blood clots with low blood platelets have been reported following vaccination with Johnson & Johnson’s product, one in a clinical trial and three cases occurring in the vaccine rollout in the US. One of them was fatal.

The Johnson & Johnson vaccine is currently only available in the US, but was authorised in the EU on 11 March 2021. Vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.

EMA said the reports of blood clots – which have the same unusual presentation as those seen with the AstraZeneca vaccine - point to a “safety signal” but it is currently not clear whether there is a causal association.

The agency also announced its started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated the AstraZeneca vaccines. There have been five cases of the very rare disorder, which is characterised by leakage of fluid from blood vessels, causing tissue swelling and a drop in blood pressure.

EMA says rare blood clots are side effect of AstraZeneca COVID-19 vaccine

The European Medicines Agency’s safety committee has concluded that unusual blood clots are a very rare side effect of AstraZeneca’s COVID-19 vaccine, but said the benefits of using it still far outweigh the risks.

It is not recommending any restrictions on who should receive the vaccine, saying there is no evidence of any specific risk factors, including any greater risk for women, or for younger age groups.

The safety committee carried out a review of 62 cases of blood clots in the brain and 24 cases of clots in the abdomen, reported in the EU drug safety database, as of 22 March 2021. Of these, 18 cases were fatal. Around 25 million people had received the AstraZeneca vaccine at this point.

There is now more data to review, with a total of 169 cases of brain clots and 53 cases of abdominal clots reported up to 4 April. Around 34 million people had been vaccinated in Europe (including the UK) by this date. EMA said the more recent data do not change the recommendations.

EMA is sending out a message to healthcare professionals and people receiving the vaccine to be aware of the possibility of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination, setting down the symptoms and the particular features of the clots. The agency said the condition can be treated if the signs are recognised and appropriate drugs are given.

“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” EMA said.

It will be up to member states to decide what action to take, depending on the pandemic situation and vaccine availability. Denmark, Netherlands and Latvia have stopped using the AstraZeneca vaccine, while others including France, Spain and Germany, are restricting its use to older people.

EMA has commissioned new studies and amendments to ongoing research to try and undercover the mechanisms behind the blood clots.

The UK’s Medicines and Healthcare products Agency stopped short of saying there is a causal link in its review of 79 cases of rare blood clots that have caused 19 deaths in the country. The link is stronger than seen previously, but not proven, and more research is needed, MHRA said.

MHRA is also updating its guidance to healthcare professionals to make them aware of the rare adverse events, but maintains the benefits are greater than the risks.

However, the Joint Committee on Vaccination and Immunisation (JVCI), which advises the UK government on the COVID-19 vaccines programme, said the risk/benefit profile for younger people has shifted as a result of the review. It changed its recommendations to say healthy people aged 18 – 29 should be offered an alternative to the AstraZeneca vaccine.

French biotech Valneva announces positive results in COVID-19 vaccine trial

The French biotech company Valneva has announced positive data for the first part of the phase I/II clinical trial of its COVID-19 vaccine and said it plans to commence a phase III trial by the end of this month.

The phase I/II study, funded by the UK government, tested three different doses of the vaccine, which consists of whole, inactivated SARS-CoV-2 virus and an adjuvant to boost the immune response. Based on the data, Valneva has decided to advance the high dose into the phase III clinical trial.

The vaccine was generally safe and well tolerated across all doses, with no safety concerns identified by an independent safety monitoring board. More than 90% of all study participants developed significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested and the vaccine also induced broad T-cell responses.

The aim is to complete phase III and apply to the UK regulator, the Medicines and Healthcare products Regulatory Agency, for approval of the vaccine in the autumn 2021. Valneva said discussions with other regulatory bodies are ongoing.

Thomas Lingelbach, CEO of Valneva, said, “Given the potential advantages often associated with inactivated whole virus vaccines, we believe that [our vaccine] has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process.”

In addition to funding the clinical trial, the UK government has invested money in Valneva’s manufacturing facility in Livingston, Scotland, where the inactivated virus is produced. The manufacturing process has already been upscaled to final industrial scale. From Scotland, the bulk material will go to the company’s plant in Solna, Sweden, where it will be put into vials.

In September 2020, Valneva struck a deal with the UK government to supply 60 million doses at a cost of €470 million. They were due to be delivered this year, but announcing the phase I/II results Valneva said the timeline for delivery will now extend into 2022.

Last month the UK government announced it would begin a revaccination campaign in the autumn, in an attempt to ensure protection from COVID-19 infection conferred by the current vaccination programme is maintained. Valneva said continues to work closely with the government to review plans, including meeting the UK’s booster campaign requirements, and on the potential development of a vaccine that is effective against emerging variants of the SARS-CoV-2 virus that threaten to undermine the effectiveness of existing vaccines.

Pfizer/BioNTech COVID 19 vaccine works in adolescents

Pfizer and BioNTech announced that their COVID-19 vaccine showed 100% efficacy and robust antibody responses in a phase III trial in adolescents 12 to 15 years of age. The results exceed those recorded earlier in participants aged 16 to 25 years old.

These are the topline results from a phase III trial involving 2,260 adolescents, who had not previously been infected with SARS-CoV-2.

“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, CEO of Pfizer. The data will be submitted to regulators in the coming weeks, “With the hope of starting to vaccinate this age group before the start of the next school year,” Bourla said.

The trial enrolled 2,260 adolescents 12 to 15 years of age in the US. There were 18 cases of COVID-19 in the placebo group and none in the vaccinated group. Vaccination elicited SARS-CoV-2–neutralizing antibody, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well with the response seen in participants aged 16 to 25 years old. The vaccine was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.

The companies plan to submit the data to the FDA and EMA to request an amendment to the current approvals.

Last week, the first children were vaccinated in a global phase I/II/III seamless study to assess the safety, tolerability, and immunogenicity of the vaccine in children aged 6 months to 11 years of age.

Glaxo to fill vials for US biotech Novavax COVID-19 vaccine, for use in UK

GlaxoSmithKline (GSK) announced it will carry out fill and finish of up to 60 million doses of the COVID-19 vaccine developed by the US biotech Novavax that have been ordered by the UK government.

GSK will provide capacity at its facility in Barnard Castle in north east England, from May 2021, with rapid technology transfer between the two companies beginning immediately, the pharma company said on Monday.

The raw material for the Novavax vaccine is also produced in the region, by Novavax manufacturing partner, Fujifilm Diosynth Biotechnologies, at its site in Billingham.

The UK government has ordered 60 million doses of the vaccine under an advance purchase agreement with Novavax.

The UK Vaccine Taskforce has played a key role in enabling production of the Novavax vaccine in Europe, supporting clinical trials and manufacturing, and now arranging for GSK to do fill and finish.

Health minister Matt Hancock said, “We've all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK’s vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine.”

The Novavax product has shown strong potential efficacy in phase III clinical trials, including against the B.1.1.7 variant of concern that is driving a third wave of infections in Europe.

It is expected Novavax will apply for approval from the UK Medicines and Healthcare products Agency during the next three months.

Full results from AstraZeneca US trial show COVID-19 vaccine has 76% efficacy

Following unprecedented public criticism from the US National Institute of Allergy and Infectious Diseases that the interim results of the US phase III trial of its COVID-19 vaccine published on Monday, were “outdated” AstraZeneca has rushed to complete the full primary analysis.

The results, published this morning show the vaccine has 76% efficacy in preventing symptomatic COVID-19 infections.

That is 3% lower than in the interim analysis, but is consistent with the interim result, given the range of possible values (confidence interval) of 68% to 82%.

AstraZeneca said the results have been presented to independent experts monitoring the trial who raised the concern that the data presented on Monday were incomplete. The primary analysis is pre-specified in the trial protocol and will be the basis for the company to apply for US Food and Drug Administration approval in the coming weeks, the company said.

Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca said, "The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for emergency use authorisation in the US and preparing for the rollout of millions of doses across America."

US phase III results underline safety and efficacy of AstraZeneca’s COVID-19 vaccine

Results of the AstraZeneca US phase III trial of AZD1222, released this morning, show statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 infections and 100% efficacy at preventing severe disease and hospitalisation.

The interim safety and efficacy analysis is based on 32,449 participants, in whom there were 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board did not identify any safety concerns related to the vaccine. This included a specific review of blood clots and the more serious cerebral venous sinus thrombosis, which caused use of the vaccine to be suspended in Europe earlier this month.

Ann Falsey, professor of medicine at University of Rochester School of Medicine, who is co-lead principal investigator for the trial, said the findings reconfirm previous results. “This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca said the results add to the growing body of evidence showing the vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. “We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US emergency use authorisation,” he said.

Benefits of AstraZeneca COVID-19 vaccine outweigh the risks, despite link to rare blood clots not being ruled out

The safety committee of the European Medicines Agency said the benefits of AstraZeneca’s vaccine in combating the still widespread threat of COVID-19 infection continue to outweigh the risk of side effects.

The vaccine is not associated with an increase in the overall risk of blood clots (venous thrombosis), while COVID-19 infection itself results in clotting problems that may be fatal. Overall, the number of thromboembolic events reported after vaccination, both in clinical trials before approval and after rollout of vaccination campaigns, was lower than that expected in the general population, EMA said.

There is also no evidence of a problem related to specific batches of the vaccine, or to particular manufacturing sites.

However, there remains a question over whether the vaccine may be associated with some very rare cases of specific types of thromboses. While around 20 million people in the EU and UK had received the AstraZeneca vaccine as of March 16, EMA has received reports of 25 such cases. The safety committee said a causal link with the vaccine is not proven, but on the basis of available evidence could not rule out a connection, and it will now carry out further analyses.

A warning about the possibility of rare clotting disorders will be added to the label on the vaccine and the patient information leaflet, but the safety committee said the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of serious thromboses.

Germany, France, Italy and other EU countries that stopped using the AstraZeneca vaccine pending the safety review said they would resume its use.

Commission tells member states to set up systems to monitor COVID-19 in sewage

Sewage monitoring needs to be included in national testing programmes for tracking SARS-CoV-2, as part of an update of testing strategies to detect mutated variants of the virus that may be more transmissible and/or cause more serious disease.

EU funding will be made available to support deployment, the analysis samples for the presence of variants and for the exchange of data, to inform preparedness and response measures.

The monitoring systems, to be in place no later than October 2021, should include all towns and cities with populations greater than 150,000, with minimum sampling frequencies of twice a week. The initiative is part of a common path to safe and sustained ending of lockdown measures published by the Commission on Wednesday.

After vaccines, Commission to turn its attention to drugs

The Commission is to set out a common EU strategy on COVID-19 therapeutics in mid-April, to parallel the approach it used to promote vaccines research and procurement.

The move was announced as part of a common path to safe and sustained lifting of COVID-19 lockdown measures across the EU, published on Wednesday.

Currently, a number of instruments including joint procurement, are being used to secure access for member states to the limited number of drugs that are available to treat COVID-19 infections. But the Commission says, “More and faster action is needed.” The aim of the strategy will be to speed up research and manufacturing.

There will also be more flexibility around drug regulation to enable rapid supply at large scale during the pandemic.

Commission to spend €12M on disinfection robots

As part of its support for member states in the fight against COVID-19, the European Commission is purchasing 200 ultraviolet light disinfecting robots, for delivery to hospitals around Europe during 2021.

The robots can disinfect a standard size patient room in as little as 10 minutes and can clean more than 18 rooms on one charge. This will help ensure a sterile environment in hospitals, without exposing staff to unnecessary risk.

The €12 million programme got underway following a study by researchers from the European Society of Clinical Microbiology and Infectious Diseases looking at the feasibility of deploying the robots, which was published last month.

This concluded disinfection robots have already been shown to be a promising tool for surface decontamination in hospitals, with even greater potential to come. Adjustments to both hospitals and devices are needed to allow the free movement of robots. More research is required to define effective wavelengths and exposure times, to allow sufficient energy to be applied to each surface, as a function of which pathogen is to be inactivated.

EMA meets to review AstraZeneca vaccine safety, while Commission agrees extra BioNTech doses

The European Medicines Agency’s safety committee is meeting on Tuesday to review data on AstraZeneca’s COVID-19 vaccine after several member states suspended its use following reports of blood clots in people who received the vaccine.

EMA said it is working with the company, experts in blood disorders and other health authorities. These include the UK Medicines and Healthcare products Agency, cut out of EMA as a result of Brexit, but now sitting on a large safety database, with around 11 million doses of the vaccine administered in the UK to date, and few reports of serious adverse events.

Meanwhile, in an attempt to fill the gap, Pfizer and BioNTech have agreed with the European Commission to accelerate delivery of ten million doses of their vaccine between April and June.

Commission President Ursula von der Leyen said, “These accelerated ten million doses will bring the total doses of Pfizer/BioNTech in quarter two up to over 200 million.” This gives member states room to manoeuvre, she said.

These doses will be drawn forward from the 100 million doses that were due to be delivered in Q3 and Q4 of 2021.

EMA said its experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the AstraZeneca vaccine might have contributed, or if blood clots could have been due to other causes. After reviewing the data today, EMA has called a meeting on Thursday to decide on any further action.

While it investigates, EMA said it currently remains of the view that, “The benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.”

Artificial intelligence not clever enough for COVID-19 diagnosis

More than 300 COVID-19 machine learning models were described in papers published in 2020 but none is suitable for detecting or diagnosing COVID-19 from standard medical imaging, due to biases, methodological flaws, lack of reproducibility, and inappropriate datasets, according to a systematic review.

Researchers led by Cambridge University reviewed 2,212 studies published between 1 January and 3 October 2020, describing machine learning models that claimed to be able to diagnose or predict the severity of COVID-19 from chest Xrays or computed tomography images.

After quality screening, 62 studies were included in the systematic review. None of the 62 models was of potential clinical use, according to results reported in Nature Machine Intelligence.

“Any machine learning algorithm is only as good as the data it's trained on,” said first author Michael Roberts from the department of applied mathematics at Cambridge University. "Especially for a brand-new disease like COVID-19, it's vital that the training data [are] as diverse as possible because, as we've seen throughout this pandemic, there are many different factors that affect what the disease looks like and how it behaves."

EMA recommends fourth COVID-19 vaccine for approval

The European Medicines Agency has recommended approval of Johnson & Johnson’s single dose COVID-19 vaccine.

“With this latest positive opinion, authorities across the EU will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director. “This is the first vaccine which can be used as a single dose.”

Results from a clinical trial involving 44,000 people in the US, South Africa and Latin American countries found there was a 67% reduction in the number of symptomatic COVID-19 cases after two weeks in people who received the vaccine (116 cases out of 19,630 people), compared with people given placebo (348 of 19,691 people).

The vaccine is already approved in the US.

GSK says its monoclonal antibody drug is 85% effective

GlaxoSmithKline and its US partner Vir Biotechnology said the independent data monitoring committee has recommended the phase III trial evaluating their antibody drug VIR-7831 in the treatment of mild to moderate COVID-19 in adults at high risk of progressing to a serious infection should be stopped, after an interim analysis found it is highly effective.

The recommendation was based on an analysis of data from 583 patients, which demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831, compared to placebo.

Based on these results, Vir and GSK plan to submit an application for an emergency use authorisation in the US and other countries.

The companies also announced the results of a new study demonstrating VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data.

George Scangos, CEO of Vir said, “The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics.”

VIR-7831 promises to be important in preventing people with COVID-19 who are treated at home progressing to more serious infection. Currently, the drug does have to be administered intravenously, but the two partners are also running a trial to see if it can be administered by a single intramuscular injection.

Real world evidence show Pfizer/BioNTech vaccine works

Pfizer and BioNTech have announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with their COVID-19 vaccine.

These new data build upon and confirm previously released data from the rollout of the vaccine in Israel, demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, hospital admissions, severe and critical cases and deaths.

This latest analysis shows that two weeks after the second dose, protection is even stronger, with vaccine effectiveness of at least 97% in the prevention of symptomatic infections, severe/critical disease and death.

The findings are based on surveillance data collected between 17 January and 6 March 6, when the Pfizer/BioNTech vaccine was the only vaccine available in the country, and when the more transmissible B.1.1.7 variant of SARS-CoV-2 first detected in the UK, was the dominant variant.

The analysis also found the vaccine is 94% effective against asymptomatic SARS-CoV-2 infections. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose.

The findings, which suggest the vaccine may also provide protection against asymptomatic SARS-CoV-2 infections are “particularly meaningful as we look to disrupt the spread of the virus around the globe,” said Luis Jodar, chief medical officer of Pfizer Vaccines.

Finnish researchers get ready to start human trials of nasal spray COVID-19 vaccine

A new academic spin-out, Rokote Laboratories is preparing the ground for clinical trials of a nasally administered COVID-19 vaccine, after the spray performed well in animal studies.

The vaccine, based on research carried out at the University of Helsinki and the University of Eastern Finland, uses a non-replicating adenoviral vector to deliver the genetic code for a SARS-CoV-2 protein, causing nasopharyngeal cells to generate the protein and spark an immune response.

The researchers chose nasal delivery because the virus is also naturally transmitted through the airways. It is expected nasal administration will induce a wider immune response than the intramuscular injections used for existing COVID-19 vaccines.

The vaccine is also designed to be effective against emerging variants of SARS-CoV-2. “Our vaccine already takes into account the most important variants, that is, the South African, Brazilian and the UK one. There will certainly be a demand for this type of vaccine," said Kalle Saksela, professor of virology at the University of Helsinki.

There is manufacturing in place to produce the vaccine in Kuopio and Rokote will carry out the first clinical trials in Finland. The company is now seeking funding for the further development of the vaccine.

French biotech Abivax halts late stage clinical trial of COVID-19 drug

Abivax said it was stopping the phase IIb/III clinical trial of its combined antiviral/anti-inflammatory drug, ABX-464, in high-risk COVID-19 patients, after the independent data safety and monitoring board said there was a lack of efficacy.

The multinational trial, which had recruited 500 high-risk COVID-19 patients out of a planned 1,034, was declared a ‘National Research Priority’ by the French government in December 2020.

The study was a randomised, double-blind and placebo-controlled design to test whether ABX-464 could prevent the development of severe COVID-19 disease in the participants. The recommendation to stop the trial was based on a planned, interim analysis evaluating data from 305 patients who completed the study. The comparison of the data generated in the patient group treated with ABX-464, versus the placebo group who received standard of care, did not show a difference in the rate of severe disease.

Jorge Kalil, head of clinical immunology and allergy at the University Hospital Centre in São Paulo and national coordinator of the study in Brazil, said, “As an immunologist, I am puzzled by the outcome of the interim analysis, as ABX-464 addresses both the viral and inflammatory aspects of the disease. However, we recognise that COVID-19 is a novel, hyper-acute and complex disease that involves various viral and inflammatory pathways, plus the coagulation system, which are still not fully understood.”

EMA starts rolling review of Russia’s Sputnik V COVID-19 vaccine

The European Medicines Agency said it has begun a rolling review of Sputnik V, the COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The application for EMA approval has been made by the contract manufacturer R-Pharm Germany GmbH.

Rolling review is a way of speeding up the approvals process by assessing data from clinical trials as soon as it is available, rather than waiting until the full data package is complete. The decision to start the rolling review is based on results from laboratory studies and clinical trials indicating Sputnik V triggers an immune response against SARS-CoV-2 coronavirus that could protect against the infection.

Sputnik V is similar to the AstraZeneca COVID-19 vaccine in using adenovirus vectors to deliver the genetic code for the SARS-CoV-2 spike protein by which the virus enters human cells.

However, while AstraZeneca’s vaccine uses the same vector for each dose, Sputnik V uses two different viruses. The aim is to avoid a possible neutralising effect, making for a more effective defence against COVID-19 than using the same vector for both doses.

Sputnik V received validation from the western science establishment in February when the medical journal The Lancet published results of the phase III trial in a peer reviewed paper. The results showed the vaccine is 91% effective.

Germany changes policy on AstraZeneca COVID-19 vaccine

Germany’s health minister Jens Spahn followed France in reversing the decision not to administer AstraZeneca’s COVID-19 vaccine to people over 65 years of age.

Spahn also said the German government will adopt the policy used in the UK, of maximising the public health benefits of limited vaccine supplies, by giving as many people as possible their first dose. Second doses will be administered 12 weeks later, rather than after four weeks, as prescribed on the label.

The change follows publication of three real world studies carried out in the UK, showing a single dose of either AstraZeneca or Pfizer/BioNTech’s COVID-19 vaccine is having a dramatic effect in reducing the number of people over 70 years of age who are admitted to hospital.

The most recent study by researchers at Bristol University published on Wednesday, showed Pfizer/BioNTech was 79.3% effective and AstraZeneca 80.4% effective, in reducing the chances of the most elderly and frail people over the age of 80 being admitted to hospital as a result of serious infection.

Adam Finn, professor of paediatrics at Bristol University and chief investigator on the study, noted the findings are relevant for countries in Europe, which decided not to administer the AstraZeneca vaccine to people over 65, despite the European Medicines Agency approving it for use in this age group.

Finn, who is chair of the World Health Organisation’s European expert technical advisory group on immunisation, which advises on vaccination programmes, told a press briefing, “There are lots of doses of AstraZeneca vaccine available in European countries and they are not being given to people over the age of 65; in some cases over the age of 55, for lack of data.”

“Well here are the data. There are data from Public Health England and Public Health Scotland, and now from us, showing that you can save lives in elderly people by giving them a dose of vaccine,” Finn said.

On Tuesday, France’s regulator Haute Autorité de santé reversed its position that AstraZeneca’s vaccine should only be administered to people under 65, citing the study carried out by Public Health Scotland.

Global carbon emissions fell by 7% due to COVID-19 restrictions

Global CO2 emissions declined by around 7% in 2020 compared to 2019 levels, as a result of the lockdown policies implemented around the world to slow the spread of COVID-19.

The data, published in Nature Climate Change, highlight the scale of action and international adherence needed to sustain such reductions post-COVID-19.

Building on their previous work, Corinne Le Quéré and colleagues at the University of East Anglia in the UK report an annual summary of global CO2 emissions for 2020, assessing the impact of COVID-19 restrictions on emissions throughout the year.

They find that global CO2 emissions fell by around 2.6 gigatonnes in 2020, the largest decrease observed to date, to approximately 34 gigatonnes of CO2. This represents a decrease of around 7% over the course of the year compared to 2019 levels.

In contrast, emissions trends in different countries since the adoption of the Paris climate agreement in 2015, show that in high-income countries, emissions had declined by 0.8% per year on average since the Paris agreement, with a further decrease of 9% in 2020 due to COVID-19.

In upper-middle-income countries, growth in emissions had slowed by 0.8% per year since 2015 and declined by 5% in 2020, while in lower income countries, emissions had been increasing by 4.5% per year since 2015, and decreased by 9% in 2020.

The researchers say that decreases in emissions owing to temporary COVID-19 restrictions alone will not result in long-term reductions. In order to sustain decreases in global emissions while supporting economic recovery, large scale deployment of renewable energy and disinvestment in fossil-fuel infrastructure worldwide will be necessary.

France changes policy on AstraZeneca COVID-19 vaccine

People over 65 years of age in France will now have access to AstraZeneca’s COVID-19 vaccine, after the regulator Haute Autorité de santé announced a change in policy.

That followed publication of more real world data from the UK vaccination programme, showing this vaccine is equally as effective as that manufactured by Pfizer/BioNTech in preventing serious disease and hospitalisation in people aged over 70.

The research also shows that on top of the protection against symptomatic disease, people vaccinated with one dose of the Pfizer/Biontech product had a lower risk of death. There is not yet enough data to assess the effect of the AstraZeneca vaccine on mortality due to its later rollout.

Combined with the effect against symptomatic disease, this indicates that a single dose of either vaccine is approximately 80% effective at preventing hospitalisation, and a single dose of Pfizer/BioNTech is 85% effective at preventing death from COVID-19.

Taken overall, the data from Public Health England show a single dose of either vaccine was associated with a significant reduction in symptomatic SARS-CoV-2 positive cases in older adults, with even greater protection against severe disease. Both vaccines show similar effects and protection was maintained for the duration of follow-up of six weeks.

Also of note, both vaccines remain effective against the B 1.1.7 variant of concern that was first identified in the UK, and has been reported across Europe and elsewhere.

Commission approves €40M state aid for Italian biotech’s COVID-19 vaccine

The European Commission has approved €40 million in Italian government grant funding to support biotech ReiThera’s development of its COVID-19 vaccine.

Last November Rome-based ReiThera announced the phase I clinical trial was advancing on schedule and that preliminary results in 45 volunteers, aged 18 – 55 years showed its vaccine was well-tolerated and generated antibodies and T-cell responses at all three doses tested.

The ReiThera vaccine is similar to that made by AstraZeneca, in using a replication defective ape adenovirus as the vector to deliver the genetic code for the spike protein by which COVID-19 enters human cells. In the case of ReiThera, the vector is derived from a gorilla; AstraZeneca’s vaccine uses a chimpanzee-derived vector.

Development of the ReiThera vaccine is a three-pronged, multinational effort, with German biotech Leukocare working on a stable formulation and Univercells in Brussels handling scale-up and manufacturing.

The €40 million grant, approved under the EU’s state aid temporary framework, will fund the phase II/III trial to confirm safety and demonstrate efficacy of the vaccine.

Pfizer and BioNTech to test effects of third dose of vaccine against variants of SARS-CoV-2

Pfizer and BioNTech have begun testing the safety and immunogenicity of a third dose of their COVID-19 vaccine to assess the effect of a booster on immunity against infection by circulating and potential newly emerging SARS-CoV-2 variants.

The study will draw upon participants from the phase I study in the US, who will be offered the opportunity to receive a booster of the current vaccine 6 to 12 months after receiving their initial two doses.

Separately, Pfizer and BioNTech are talking to the US Food and Drug Administration and the European Medicines Agency about a trial of a variant-specific vaccine targeted against the B.1.351 variant, first identified in South Africa. This could position the companies to update the current vaccine quickly if the need arises.

Both FDA and EMA have said they will regulate updated versions of COVID-19 vaccines in the same way as the approval process currently in place for annual updates of flu vaccines.

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and immunity against circulating strains,” said Albert Bourla, CEO of Pfizer. “At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorisation for an updated mRNA vaccine or booster if needed.”

Ugur Sahin, CEO of BioNTech, said, “The flexibility of our proprietary mRNA vaccine platform allows us to technically develop booster vaccines within weeks, if needed. This regulatory pathway is already established for other infectious diseases like influenza. We take these steps in order to ensure a long-term immunity against the virus and its variants.”

The study will evaluate up to 144 phase I participants in two age cohorts, 18-55 and 65-85 years of age. It will include trial participants who received the two doses in the phase I study 6 to 12 months ago in order to assess if a third dose protects against variants.

Participants will be assessed at the time they receive the third dose, then one week and one month after, to see if blood samples neutralise SARS-CoV-2 variants of concern. The participants will continue being followed in the study for up to two years, as originally planned.

Moderna completes initial production of vaccine against variant first found in South Africa

US biotech Moderna announced it has completed manufacturing of clinical trial material of a vaccine designed to protect against the SARS-CoV-2 variant known as B.1.351, which was first identified in South Africa, and has shipped doses to the US National Institutes of Health (NIH) for a phase I clinical trial, to be led and funded by NIH.

While initial data confirms the approved Moderna COVID-19 vaccine works against B.1.351, the company is evaluating using booster doses of vaccine to increase neutralising immunity against this and other variants of concern.

“We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration,” said Stéphane Bancel, CEO of Moderna. “Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control.”

At the same time, Moderna said it is making new capital investments to increase manufacturing capacity at its own and partner’s facilities. This will increase 2022 manufacturing capacity to approximately 1.4 billion doses. Given the six to nine months needed to add capacity and further time to get regulatory approval, it is estimated it will be 12 months before the additional production is available.

“We are investing in this additional capacity to help us increase production and allow for flexibility in manufacturing potential vaccine boosters to address emerging variants of the virus,” said Bancel.

Moderna is also increasing its base plan for 2021 manufacturing from 600 million doses to 700 million doses, and is exploring other approaches to potentially improve throughput, working to further optimise operations to potentially deliver up to one billion doses in 2021.

To date, the company has shipped approximately 60 million doses globally including approximately 55 million doses shipped to the US government and four million doses from its ex-US supply chain.

More than 87,000 scientific papers published on coronavirus since pandemic began

Scientists from around the world published more than 87,000 papers about the SARS-CoV-2 coronavirus between the start of the COVID-19 pandemic and October 2020, a new analysis shows.

Even given the context of the pandemic, researchers were surprised by the huge number of studies produced on the subject in such a short time.

"It is an astonishing number of publications, it may be unprecedented in the history of science," said Caroline Wagner, associate professor at Ohio State University, who is co-author the research, published in Scientometrics.

The analysis, carried out with Xiaojing Cai at Zhejiang University in China, and Caroline Fry at the University of Hawaii, found 4,875 COVID-19 related articles were published between January and mid-April 2020. That rose to 44,013 by mid-July and 87,515 by the start of October.

Wagner compared the amount of journal papers on the coronavirus to the attention given to nanotechnology, which was one of the hottest areas in science during the 1990s. It took more than 19 years to go from 4,000 to 90,000 scientific articles on that topic. "Coronavirus research reached that level in about five months," she said.

This new study was an update of an earlier one published in July 2020, which found that China and the US led the world in coronavirus research during the early months of the pandemic.

The new study shows China's contributions dropped off significantly after infection rates in the country fell. From Jan. 1 to April 8, Chinese scientists were involved in 47% of all worldwide publications on the coronavirus. That dropped to only 16% from July 13 to October 5.

Similar results were found in other countries when infection levels dropped among their populations.

"At the beginning of the pandemic, governments flooded scientists with funding for COVID research, probably because they wanted to look like they were responding," Wagner said. "It may be that when the threat went down, so did the funding."

In China, the work was also slowed by a government requirement that officials approve all articles related to COVID-19, according to Wagner.

The rate of international collaborations also continued to drop, the study found. Part of the reason was the practical barrier that travel bans made it impossible for researchers to meet.

But there may have also been a political component, Wagner said, particularly in US-China collaborations. The Chinese government's requirement of study review is one factor, but in addition, the US government has been putting Chinese researchers in the US under scrutiny, which may have led some scientists to forgo partnerships.

"We need to figure out a way to restart these collaborations as we move into the post-COVID period," Wagner said. "International cooperation is crucial for the scientific enterprise."

Real world data from Scotland show COVID-19 vaccines prevent serious illness

COVID-19 vaccination has been linked to a substantial reduction in the risk of being admitted to hospital with COVID-19, according to the first population-level study of a live vaccination programme.

The data cover 1.1 million of 5.4 million people in Scotland to have received the first dose of either the Pfizer/BioNTech or AstraZeneca vaccines, confirming previous results about vaccine efficacy from clinical trials.

By the fourth week after receiving the initial dose, the Pfizer/BioNTech reduced hospitalisation by 85% and AstraZeneca by 94%, respectively.

The finding is significant because there were not many older people in the AstraZeneca phase III clinical trial. That led Germany to say this vaccine should not be given to the over 65s, but now the data indicate AstraZeneca may be more protective than the Pfizer/BioNTech vaccine in the older age groups.

Among those aged 80 years and over - one of the highest risk groups - vaccination was associated with an 81 per cent reduction in hospital admissions in the fourth week, when the results for both vaccines were combined.

The level of protection seen after a single dose is also an important corroboration of the UK’s controversial policy of maximising population level protection by giving as many first doses to as many people as possible. That is at odds with what it says on the labels of the vaccines, which is that the second dose should be three weeks after the first for Pfizer/BioNTech and four weeks for AstraZeneca

As part of the EAVE II project, which uses patient data to track the pandemic and the vaccine roll out in real time, researchers from the universities of Edinburgh, Strathclyde, Aberdeen, Glasgow and St Andrew’s and Public Health Scotland analysed a dataset covering the entire Scottish population of 5.4 million.

Data on vaccine effect was gathered between 8 December and 15 February. During this period, 1.14 million vaccines were administered and 21% of the Scottish population had received a first dose.

The Pfizer/BioNTech vaccine had been received by some 650,000 people and 490,000 had had the AstraZeneca vaccine.

Researchers analysed data for every week during this period, including GP records on vaccination, hospital admissions, death registrations and laboratory test results, and compared the outcomes of those who had received their first dose with those who had not.

Modelling how virus changes shape to enter human cells provides new drug targets

Dynamic modelling of the movements of the proteins in the spike structure via which SARS-CoV-2 enters and infects human cells, has led to the identification of a 'hinge' mechanism, that gives the spike of the virus purchase to hook onto the cell.

The modelling also pinpointed changes in the shape of the virus that then enable it to fuse with the host cell membrane and enter the hooked cell.

The research, led by Warwick University as part of Eutopia, an alliance of six universities funded by the EU Erasmus+ programme, involved simulating movements in the structure of 287 proteins of the Covid-19 virus, in an effort to identify drug targets.

In a paper published in Scientific Reports, the team of physicists and life scientists have made their data, movies and structural information, detailing how the proteins move and how they deform, publicly accessible.

“Knowing how this mechanism works is one way in which you can stop the virus, and in our study we are the first to see the detailed movement of opening,” said lead author, Rudolf Roemer, professor in the department of physics at Warwick University, who did the work while on a sabbatical at CY Cergy-Paris Université. “Now that you know what the range of this movement is, you can figure out what can block it,” he said.

South African variant reduces level of protection, but Pfizer/BioNTech vaccine remains effective

Pfizer and BioNTech announced results from a laboratory study that provides additional data on the capability of blood samples from individuals immunised with their COVID-19 vaccine to neutralise variants of the SARS-CoV-2 that have the South African mutations in the spike protein.

This study, which builds on previous work, was conducted by Pfizer and the University of Texas Medical Branch and investigated the full set of South African variant (also known as B.1.351) spike mutations.

Three genetically engineered recombinant viruses were produced, one with the full set of spike mutations found in the South African variant and the other two with subsets of these mutations. These viruses were tested against blood from 15 participants who were immunized in the previously reported phase II trial.

Although the results indicated a reduction in neutralisation of virus with all the South African variant spike glycoprotein mutations, all the blood samples neutralised all the viruses tested.

The two companies said there is also no clinical evidence to date that the South African variant virus escapes the protection provided by their vaccine. However, Pfizer and BioNTech are taking steps and making investments to be in a position to develop and seek authorisation for an updated mRNA vaccine or booster once a variant that significantly reduces the protection from the vaccine is identified.

Commission sets out plan to deal with variants of SARS-CoV-2

The Commission has announced a European bio-defence preparedness plan against COVID-19 variants, which will bring together researchers, biotech companies, manufacturers and public authorities in the EU and globally, to detect new variants of SARS-CoV-2 that could reduce the efficacy of vaccines.

There will be incentives to develop new and adapted vaccines, speed up regulatory approval and support scale up of manufacturing capacities.

Key actions will include developing tests for new variants; supporting viral genome sequencing in member states with at least €75 million in EU funding to reach the target of sequencing 5% of viral samples from positive tests to help identify variants, monitor their spread and assess their impact on transmissibility; and speeding up research and data exchange on variants with €150 million funding.

Commission buys 150M more doses of Moderna COVID-19 vaccine

US biotech Moderna said the European Commission is buying an additional 150 million doses of its COVID-19 vaccine, bring confirmed orders to 310 million doses for delivery in 2021. The latest doses are scheduled to be delivered in the third and fourth quarter of the year.

Under the terms of the agreement, the Commission has an option to purchase an additional 150 million doses for delivery in 2022.

Stéphane Bancel, CEO of Moderna, said, “The European Commission is in discussions with us on how to prepare for 2022, including addressing potential variants [of the virus].”

Pfizer/BioNTech to supply more vaccine doses to EU

Pfizer and BioNTech have announced an agreement with the European Commission to supply an additional 200 million doses of their COVID-19 vaccine Comirnaty, to the EU.

This new agreement is in addition to the 300 million doses that have already been committed to the EU in 2021 under the first supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.

The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on an option granted in the new agreement.

Albert Bourla, CEO of Pfizer said, “With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.”

“We have taken additional steps to expand our manufacturing capacity to two billion doses in 2021,” said Ugur Sahin CEO of BioNTech. “We will initiate production at our Marburg facility this month.”

UK government funds phase I clinical trials to fast-track new treatments for COVID-19

The UK government has awarded funding to extend its support for COVID-19 clinical trials to the earliest phase I studies, making it possible to rapidly progress new therapies through all stages of development in the country.

Four therapies have so far been selected for phase I development. Future treatments will be selected by the UK COVID-19 therapeutics advisory panel, which is open to receiving proposals from academic groups and companies.

Currently, the government is funding phase II and III studies, including the large scale Recovery trial, which is testing existing drugs in hospitalised COVID-19 patients. The randomised study, which recruited its 36,000 patient last week, has found two therapies, dexamethasone and tocilizumab, that are effective, and shown that four suggested treatments are not.

Phase I trials are the essential first step that ensures treatments are safe. The government backing is for Agile, a phase I/IIa clinical trial platform run in a collaboration between Liverpool, Lancaster and Southampton universities, and other external partners

The design of the platform means that multiple potential treatments can be evaluated in parallel and testing can be completed in months rather than years.

Patients in the early stages of COVID-19 infection will be recruited to Agile from the community, in addition to patients who have been hospitalised with COVID-19. Drugs that show a signal of benefit in Agile will be considered for advancement into later phase clinical trials.

COVID-19 demonstrates importance of public funding in driving innovation

Policymakers should learn lessons from the success of research and development (R&D) in responding to COVID-19, to rethink approaches to tackling healthcare and environmental challenges, according to a new study.

Economists from Bath University and the International Monetary Fund examined the drivers of innovation in global pharmaceutical R&D, finding research carried out by the industry typically follows a law of diminishing effort. This means that while the global death burden of a disease doubles, the intensity of research effort rises by only 50%.

However, the scientific response to COVID-19 is a major exception, with seven to twenty times more COVID-19 clinical trials than this historical relationship would imply.

During the pandemic, global pharmaceutical R&D, as measured by the number of clinical trials, has scaled up by 38%, with only a modest reduction of research on other diseases.

But much of this response occurred via public research institutions, which account for 70% of all COVID-19 trials globally.

The researchers say their findings suggest global pharmaceutical innovation has room to grow, but that government incentives and support from public research institutions should play a crucial role in supplementing the private research.

Patrick Gaule, senior lecturer in economics at Bath University and co-author of the study said, “The rate and direction of innovation is shaped by incentives and government policy actions. Traditionally, economists have emphasised the market size as an important driver for innovation - the greater the private demand for an innovation, the more innovation we should expect in that domain.”

"However, this may not be sufficient by itself to encourage innovation to address the deadliest diseases - from coronary heart disease to lung cancer, or indeed other major challenges facing humanity, namely climate change.”

Instead, the response to COVID-19 suggests that scaling up global innovation in the future may require moves to complement the market size effect with early-stage incentives that harness the power of public research institutions and non-monetary incentives, for example altruism, Gaule said.

EMA preparing guidance to tackle COVID-19 variants

The European Medicines Agency said it is developing guidance for manufacturers planning changes to existing COVID-19 vaccines, to tackle emerging new virus variants.

The agency has asked all vaccine developers to investigate if their vaccine offers protection against new variants, such as those first identified in the UK, South Africa and Brazil, and submit relevant data.

EMA will then publish guidance on what data and studies are needed to support modifications of existing vaccines to current or future mutations of SARS-CoV-2 in the EU.

Questions that will be addressed include: what are the options for introducing a new variant into an existing approved vaccine?; what will be required to demonstrate quality, safety and efficacy of modified vaccines?; which bridging studies will be required to provide adequate reassurance of a vaccine’s efficacy against a new variant, either as first vaccination or as booster?

EMA has authorised three vaccines for use in the EU and there are concerns that some mutations could impact to different degrees the ability of the vaccines to protect against infection and disease.

A reduction in protection from mild disease does not necessarily translate into a reduction in protection from serious disease, but more evidence is needed.

Variants of SAR-CoV-2 have been present since March 2020, spreading even before the start of vaccination campaigns.

EMA is working with other regulators in the International Coalition of Medicines Regulatory Authorities to determine possible changes to the composition of COVID-19 vaccines and to align global strategy.

BioNTech starts COVID-19 vaccine production at new Marburg facility, first deliveries due in April

BioNTech has started manufacturing at its new Marburg facility, making the first batch of mRNA for its COVID-19 vaccine. The batch will produce enough active ingredient for eight million doses of the vaccine, the company said.

After initial production, the raw material will be purified and concentrated, before being encapsulated in lipid nanoparticles that both protect the mRNA and deliver it to the target lymphoid cells, generating an immune response.

Before the vaccine can be shipped the European Medicines Agency will review quality and validation data from the first production batches. This will take place in February and March. Based on approval by the EMA, the initial batches of the vaccine will be delivered to other sites to be put into vials.

BioNTech said it is working with co-developer Pfizer to respond to global demand, increasing manufacturing capacity to up to two billion doses of vaccine in 2021. However, that assumes continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers.

It also depends on updating the label on the vials, to allow six doses per vial, rather than five, as envisaged in EMA’s original approval.

Last week, Pfizer announced the modification of production processes at its facility in Puurs, Belgium, which has held up supplies, has been successfully completed. That has put the company back on track to meet the original schedule of vaccine deliveries to the EU in the first quarter, and supply up to an additional 75 million doses to the EU in the second quarter of 2021.

The initial EU order for 300 million doses in 2021 was subsequently increased to 500 million when the contract was amended in January.

The new BioNTech site in Marburg will become one of the largest mRNA manufacturing sites in Europe with an annual production capacity of up to 750 million doses, once fully operational.

BioNTech plans to produce up to 250 million doses at the facility in the first half of 2021, with the first vaccines manufactured at the Marburg site scheduled for distribution in early April.

Pandemic is accelerating the end of fossil power generation

COVID-19 has reduced the share of electricity generated by burning coal - a trend that could outlast the pandemic, according to a new German study. Researchers in Potsdam and Berlin found a window of opportunity has opened to make the current fall in coal use irreversible and say that supported by the right climate policy measures, power sector emissions could decline more rapidly than previously thought.

"Coal has been hit harder by the corona crisis than other power sources,” said Christoph Bertram from the Potsdam Institute for Climate Impact Research, lead author of a paper in Nature Climate Science. "If demand for electricity drops, coal plants are usually switched off first. This is because the process of burning fuels constantly runs up costs. The plant operators have to pay for each single ton of coal. In contrast, renewable power sources such as wind and solar plants, once built, have significantly lower running costs and keep on operating even if the demand is reduced."

In 2020 overall global CO2 emissions from the power sector decreased around 7%. In India, the US, and European countries, where monthly electricity demand declined by up to 20% compared to 2019, the fall was more marked, with monthly CO2 emissions down by up to 50%.

As long as clean electricity generation growth exceeds increases in electricity demand, CO2 emissions from the power sector will decline, because the pandemic has weakened the market position of coal-fired power generation and illustrated its vulnerability, the researchers say.

Co-author Ottmar Edenhofer, director of the Potsdam Institute and the Mercator Research Institute on Global Commons and Climate Change said, "In the end, it will certainly take carbon pricing to cut emissions at the required pace and stabilise our climate. Yet the impacts of the corona crisis on the power generation sector have put political leaders in a unique position. Along with additional policies such as eliminating subsidies for fossil fuels and increasing investments in wind and solar power, it is now easier than ever before to put an end to high-carbon electricity."

UK to start world-first study of alternating different COVID-19 vaccines

A clinical trial looking into alternating COVID-19 vaccines launching in the UK today will examine whether different vaccines can safely be used for a single person.

The study, backed by £7 million of government funding, will be the first in the world to assess the effects of using different vaccines for the first and second dose, for example, Oxford University/AstraZeneca’s vaccine for the first dose, followed by Pfizer/BioNTech’s vaccine for the second, and vice versa.

It will also gather evidence on whether different intervals between the first and second dose have an impact on the immune response.

The trial will recruit 820 volunteers over the next 2 – 3 weeks, at eight sites across the UK. It is not studying efficacy, but rather assessing the immune response to mixed vaccination. Initial results are expected in June.

As they are approved and become available, other vaccines will be added to the study.

Matthew Snape, principal investigator, said if mixed schedules are as good as two doses of the same vaccine, it will provide more flexibility with vaccines rollout and help deal with any disruption to supplies.

Deputy chief medical officer Jonathan Van-Tam said, “Given the inevitable challenges of immunising large numbers of the population against COVID-19 and potential global supply constraints, there are definite advantages to having data that could support a more flexible immunisation programme.”

It is also possible that by combining vaccines the immune response could be enhanced. “Unless this is evaluated in a clinical trial we just won’t know,” Van-Tam said.

GSK and CureVac to develop next generation mRNA COVID-19 vaccines

UK pharma company GlaxoSmithKline and German biotech CureVac announced a new €150 million collaboration to jointly develop next generation mRNA vaccines for COVID-19, aiming to provide protection again multiple variants of the SARS-CoV-2 virus that are emerging in a single vaccine.

GSK will also use its manufacturing facilities in Belgium in support of the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine CVnCoV in 2021, which is in a phase IIb/III trial.

In the co-development agreement, GSK and CureVac will share resources and expertise to develop a vaccine offering broader protection against different SARS-CoV2 variants, and to enable a quick response to new variants that emerge in the future. The development programme begins immediately, with the target of introducing a vaccine in 2022, subject to regulatory approval.

GSK will make an upfront payment to CureVac of €75m and a further payment of €75m, conditional on the achievement of specific milestones.

The vision is that next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time.

UK government increases its order for Valneva COVID-19 vaccine to potential £1.4B

French biotech Valneva reported the UK government has exercised an option to order 40 million more doses of its COVID-19 vaccine for supply in 2022. This brings the total volume ordered by the UK to 100 million doses, with the UK government also holding options over a further 90 million doses for supply between 2023 and 2025.

The Nantes-based company is in advanced discussions with the European Commission for the supply of up to 60 million doses, but has yet to sign a formal advance purchase agreement to supply vaccine to the EU.

The total value of the 190 million UK doses, if all options are exercised, is up to €1.4 billion. Valneva announced last week that it has commenced production at its facility in near Edinburgh, in parallel with ongoing clinical trials, in order to optimise the timeline for potential deliveries of the vaccine. The phase I/II clinical study is now fully enrolled and is expected to read out within the next three months.

Thomas Lingelbach, CEO of Valneva said, “We are very pleased to extend our supply commitment to the UK. Assuming success, we believe that our vaccine, which has commenced commercial production at our site in Scotland, can make a major contribution to the UK’s vaccination efforts later this year as well as in 2022. This new development in our partnership underlines the need for our inactivated vaccine approach and we will continue to work closely with the Vaccines Task Force on execution.”

AstraZeneca/Oxford COVID-19 vaccine finally authorised for use in the EU

In the midst of acrimony over supplies to the EU, the European Medicines Agency has now granted a conditional marketing authorisation for the COVID-19 vaccine developed jointly by AstraZeneca and Oxford University.

EMA based its opinion on data from a rolling review of trial data from the primary analysis of the phase III clinical development programme led by Oxford University, which included 23,745 volunteers aged 18 years and older. Additional safety and efficacy data from ongoing clinical trials is expected to be published in the coming weeks.

AstraZeneca said it is working with the EU for vaccinations to begin across member states. Problems in scaling up the manufacturing process at facilities in Belgium and the Netherlands mean the company will deliver only 40 million of an expected 80 million doses by the end of March. The EU has ordered 300 million doses of the vaccine in total.

It is hard to get to the bottom of the legal position. The contract with AstraZeneca has been published by the European Commission, but it is redacted to the extent it is impossible to interpret key aspects.

Professor Andrew Pollard, director of the Oxford vaccine group and chief investigator on the Oxford vaccine trials, said, “The approval by the European Commission is an important milestone in extending access to the Oxford/AstraZeneca vaccine in our region.”

AstraZeneca is now seeking emergency use listing from the World Health Organisation for an accelerated pathway to make the vaccine available in low income countries. The company has said it will supply the vaccine at cost in all markets during the pandemic.

The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings.

European Commission restricts exports of COVID-19 vaccines

The European Commission has put in place what it calls a targeted “transparency and authorisation mechanism”, under which individual member states could stop COVID-19 vaccines being exported outside the EU.

The Commission said the move is an effort “to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU.”

President of the European Commission Ursula von der Leyen said, “This transparency and authorisation mechanism is temporary, and we will of course continue to uphold our commitments towards low and middle income countries.”

The measure is limited to vaccines for which the EU has agreed advance purchase agreements, said executive vice president and Commissioner for trade Valdis Dombrovskis. “The aim is to provide greater clarity on vaccine production in the EU and their exports – this transparency has been lacking and is vital at this time.”

The Commission worked “for the best part of the last year” to get advance purchase agreements with vaccine producers, said Commissioner for health Stella Kyriakides. “We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised. We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens.”

The restriction on export of COVID-19 vaccines outside the EU applies until the end of March 2021.

Sanofi to lend a hand with Pfizer/BioNTech COVID-19 vaccine

After delaying its COVID-19 vaccine development plan at the end of last year, French pharma Sanofi is now stepping in to help increase supplies of the Pfizer/BioNTech product that is currently the only vaccine available for use in the EU.

Sanofi will provide BioNTech access to its production infrastructure and from summer 2021 will do late stage manufacturing at its facility in Frankfurt to supply over 125 million doses of COVID-19 vaccine for the EU.

British national Paul Hudson, CEO of Sanofi said, “Although vaccination campaigns have started around the world, the ability to get shots into arms is being limited by lower than expected supplies and delayed approval timelines owing to production shortages. We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so.”

Sanofi will continue to develop its COVID-19 vaccine, after phase I/II study showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

It plans to initiate a new phase II study in February, with support from the US Biomedical Advanced Research and Development Authority, to evaluate an improved antigen formulation in order to achieve high-level immune response across all age groups.

French biotech announces production of its COVID-19 vaccine has started in Scotland

French biotech Valneva said it has commenced production of its COVID-19 vaccine candidate in Scotland, after signing a deal with the UK government in September last year.

Production has begun in parallel with the ongoing clinical trials, in order to speed the product to market, if the vaccine is found to be safe and effective.

In September 2020, Nantes-based Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its COVID-19 vaccine. If vaccine development is successful, Valneva will supply the UK with 60 million doses in the second half of 2021.

The company announced in January 2021 that it is in advanced discussions with the European Commission for the supply of up to 60 million doses but has yet to sign a formal advance purchase agreement.

The phase I/II clinical study is now fully enrolled and is expected to report initial results in April 2021.

Thomas Lingelbach, CEO of Valneva, said, “Our team in Scotland have done an amazing job to get manufacturing started so quickly. I would like to thank the UK Vaccines Taskforce and the National Institute for Health Research who have played vital roles in the rapid recruitment and enrollment of the volunteers for the clinical study.”

UK to help rest of world find SARS-CoV-2 variants

The UK is offering its genomics resources to help countries that lack their own capabilities track variants of the SARS-CoV-2 virus that causes COVID-19.

The New Variant Assessment Platform is intended to provide an early warning of mutations that could increase the virulence of the virus, or reduce the efficacy of vaccines and therapeutics.

Countries will be able to access the platform via the World Health Organisation.

The UK has led the world in tracking the evolution of the SARS-CoV-2 genome in real time through sequencing the virus from COVID-19 patients. It currently sequences samples from 5% of patients, and has contributed half of the sequences in the global database.

The initiative will give an early warning of new variants of concern, said Isabel Oliver, director of Public Health England’s national infection service. “We know that the virus will evolve over time,” she said.

A key example is the B 1.1.7 variant, first identified in the UK in December, which is known to be more transmissible, and which initial data indicate is 30 – 40% more lethal. It has since been picked up in more than 60 countries. Other variants of concern have been identified in South Africa and Brazil.

EU proposes export controls for COVID vaccines, as row with AstraZeneca deepens

The EU is threatening to introduce export controls for COVID-19 vaccines in response to a row with AstraZeneca over supplies of its vaccine, following reports that the company is unable to meet previous commitments on deliveries. That is said to be as a result of problems at one of the manufacturing facilities.

As a result, deliveries of the AstraZeneca/Oxford University COVID-19 vaccine to the EU are expected to be 60% less than promised during the first quarter of the year.

“In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” EU health commissioner Stella Kyriakides said on Monday.

The proposal follows frustration in Brussels over an agreement with AstraZeneca to deliver around 80 million of the 300 million doses the Commission has ordered by the end of March. According to the company, it now expects that amount to be cut to 31 million doses due to "production problems" at a manufacturing site in the European supply chain.

In a statement on Monday, Kyriakides said the company’s explanations for the delay “have not been satisfactory”. A call with AstraZeneca CEO Pascal Soriot was scheduled for Monday evening.

“This new schedule is not acceptable to the EU,” Kyriakides said. “We want clarity and full transparency. The EU has pre-refinanced the development and production of the vaccine and wants to see the return. The EU wants to know exactly which doses have been produced, where, by AstraZeneca so far, and if or to whom they have been delivered.”

On 8 December, the UK Vaccine Taskforce, set up to procure COVID-19 vaccines, said rather than domestic production, the initial doses of the AstraZeneca vaccine were to be imported into the UK from mainland Europe, to get the vaccination programme off the ground as soon as the vaccine was approved by the UK regulator. That happened on 30 December.

The vaccine is not yet approved by the European Medicines Agency, but its decision is expected before Friday.

Frustration with AstraZeneca is heightened by the EU's slow vaccine rollout. Cheaper and easier to distribute compared to the approved vaccines from Pfizer/BioNtech and Moderna, officials had hoped the AstraZeneca vaccine would give the European rollout a big push.

Merck pulls the plug on Franco-Austrian COVID-19 vaccine

A COVID-19 vaccine based on technology originally developed by the Pasteur Institute in Paris and taken forward by Vienna-based Themis Bioscience, has been dropped by Merck & Co. Inc.

The US pharma company said the vaccine has failed to demonstrate good enough immune responses in phase I studies in healthy volunteers.

Merck said it is also dropping a second programme it was developing in collaboration with the non-profit organisation, AIDS Vaccine Initiative Inc (IAVI), to develop a COVID-19 vaccine based on the same technology as Merck used in its approved vaccine against Ebola virus.

According to the company, the immune responses to both vaccine candidates were inferior to those seen following natural infection and those reported for other COVID-19 vaccines.

This is a double blow, given Merck’s vaccines development and manufacturing capacity.

Merck announced it was acquiring Themis in May 2020, taking on development of the COVID-19 vaccine, which had previously received funding from CEPI, the Coalition for Epidemic Preparedness Initiative.

US to join in global fight against COVID-19

As the US re-engages with the World Health Organisation (WHO), it will also be joining WHO’s COVAX and ACT-Accelerator initiatives, set up to spur the development of vaccines and therapies, and to ensure their distribution in poorer countries.

“I am pleased to announce today that the US plans to work multilaterally to respond to and recover from the COVID-19 pandemic,” Anthony Fauci, the new US chief medical officer told a meeting of executive board of WHO this morning.

“President Biden will issue a directive later today which will include the intent of the US to join COVAX and support the ACT-Accelerator to advance multilateral efforts for COVID-19 vaccine, therapeutic, and diagnostic distribution, equitable access, and research and development,” Fauci said.

Fauci also thanked WHO for the way it has responded to the pandemic. “Under trying circumstances, this organisation has rallied the scientific and research and development community to accelerate vaccines, therapies and diagnostics; conducted regular, streamed press briefings that authoritatively track global developments; provided millions of vital supplies from lab reagents to protective gear to health care workers in dozens of countries; and relentlessly worked with nations in their fight against COVID-19,” he said.

COVID-19 research papers most captured the public’s imagination in 2020

The annual Altmetric Top 100, highlighting research and academic commentary published in 2020 that generated significant international online attention and discussion, found – unsurprisingly – that Covid-19 research accounted for roughly 30% of the top 100 papers.

These were spread across many disciplines including biomedicine, built environment and design, and economics.

Virus transmission and face mask protection were among the most heavily discussed topics in the analysis of 87.7 million mentions of 3.4 million papers.

The top articles on Covid-19 include:

Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers
Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1
It Is Time to Address Airborne Transmission of Coronavirus Disease 2019 (COVID-19)?
Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro
A modelling framework to assess the likely effectiveness of facemasks in combination with "lock-down" in managing the COVID-19 pandemic

Pfizer/BioNTech COVID-19 vaccine remains effective against virus variant

A laboratory study to test if the Pfizer/BioNTech COVID-19 vaccine is capable of protecting against a variant of SARS-CoV-2 first detected in the UK, has found that blood samples from vaccinated people neutralise the virus.

The variant, called B.1.1.7, has ten mutations located in the spike protein against which most COVID-19 vaccines are designed. To test the impact on the effectiveness of their vaccine, researchers at Pfizer/BioNTech genetically engineered a replication-deficient virus with the full set of spike mutations. Sera from blood samples of 16 people who took part in a clinical trial of the vaccine inhibited this pseudovirus in a range said to be biologically equivalent to the effect on the original virus that emerged in Wuhan, China.

BioNTech and Pfizer previously published data from a study that evaluated N501Y, one of the key mutations in the B.1.1.7 variant, which is shared by the South African variant that is also causing concern. That study showed efficient neutralisation of the N501Y mutated virus by sera of individuals who had received the Pfizer/BioNTech COVID-19 vaccine.

The two companies said further studies are needed to monitor their vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. It has not been established what reduction in neutralisation might indicate the need to modify a vaccine, but the underlying technology would enable such adjustment.

EU put in €547M to fund research in response to COVID-19 during first six months of 2020

Health may be a member state competence and an area where the European Commission has very limited powers and influence, but a review of the EU’s initial contribution to the public health response by the European Court of Auditors shows it diverted €547 million to research on COVID-19 between January and June 2020.

The Commission first committed €10 million Horizon 2020 funding for research on COVID-19 on 31 January 2020, using the provision in its work programme that had already committed this amount in case of a public health emergency.

This funding was increased to €48 million by the end of March to support 18 projects (out of 89 eligible applications) developing vaccines, diagnostics, new treatments and monitoring systems.

The Commission then launched a further call for funding applications in May 2020, with a total budget of €130 million, to support 23 projects.

The Innovative Medicines Initiative, the public private partnership between the Commission and the pharmaceutical industry, also launched a call for funding applications in March. It selected eight projects focusing on diagnostics and treatment development, which will receive in total €117 million, €72 million of which is in grants from the European budget.

Then, in April, the Commission committed another €166 million of funding in April 2020 via the EU business accelerator programme, the European Innovation Council, to 72 companies working on innovative projects related to COVID-19.

WHO says COVID-19 vaccines could become ‘another brick in the wall’ of inequality between the world’s haves and have nots

The head of the World Health Organisation Tedros Adhanom Ghebreyesus, has hit out at the disparity in access to COVID-19 vaccines, saying, “It’s right that all governments want to prioritise vaccinating their own health workers and older people first. But it’s not right that younger, healthier adults in rich countries are vaccinated before health workers and older people in poorer countries.”

There will be enough vaccine for everyone, Ghebreyesus said. “But right now, we must work together as one global family to prioritise those most at risk of severe disease and death, in all countries.”

Over the past nine months, WHO has been working through the ACT Accelerator and the COVAX vaccines programme to lay the ground for the equitable distribution and deployment of vaccines. It has secured two billion doses of vaccines from five producers, with options on more than one billion more doses. The aim is to start deliveries in February.

But several WHO member states have questioned whether COVAX will get the vaccines it needs, and whether high income countries will keep the promises they have made to donate vaccines.

“The promise of equitable access is at serious risk,” Ghebreyesus said. More than 39 million doses of vaccine have now been administered in at least 49 higher income countries. Just 25 doses have been given in one lowest income country.

“I need to be blunt: the world is on the brink of a catastrophic moral failure,” said Ghebreyesus. “Even as they speak the language of equitable access, some countries and companies continue to prioritise bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue.”

The situation is compounded by the fact that most manufacturers have prioritised getting regulatory approval in rich countries where the profits are highest, rather than submitting full dossiers to WHO, according to Ghebreyesus. “It’s not too late. I call on all countries to work together in solidarity to ensure that within the first 100 days of this year, vaccination of health workers and older people is underway in all countries,” he said.

EMA starts rolling review of J&J COVID-19 vaccine

The European Medicines Agency said it has begun the rolling review of Johnson & Johnson’s single dose COVID-19 vaccine, weighing up the evidence that is available currently, in advance of a formal application for marketing approval from the company.

The European Commission has agreed to buy 200 million doses, with the option to secure up to 200 million additional doses.

Johnson & Johnson announced last month that it has completed recruitment to the phase III trial of the vaccine, enrolling approximately 45,000 participants. There is a high level of COVID-19 infection in the countries where the trial is being conducted and the company expects there will be enough cases to show if the vaccine is effective by the end of January.

If so, Johnson & Johnson said it expects to apply for emergency use approval from the US FDA in February, with applications to other regulators made in parallel.

The latest data from the phase I/IIa trial published this week in the New England Journal of Medicine, show the vaccine prompted an immune response that lasted for at least 71 days, in participants aged 18-55 years. After a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Swiss regulator approves Moderna COVID-19 vaccine

The Swiss federal government has secured 7.5 million doses of Moderna’s COVID-19 vaccine following approval by the regulator Swissmedic, with first deliveries to the country expected to begin next week.

The authorisation is based on a rolling submission of data, including an analysis from the phase III clinical study published on 30 November.

The Moderna vaccine is also approved in the US, EU, Canada, Israel and the UK and is under review in other countries and by the World Health Organisation.

Commission on verge of signing contract for 7th COVID-19 vaccine

As it defends itself against criticisms of the slowness of the centralised procurement of COVID-19 vaccines, the European Commission said it concluded exploratory talks with French biotech Valneva to buy its potential vaccine. The contract involves an initial 30 million doses with an option for up to 30 million more.

This is in addition to contracts already signed with AstraZeneca, Sanofi/GlaxoSmithKline, Janssen, Pfizer/BioNtech, CureVac, and Moderna. The Commission has also had talks with US biotech Novavax.

The agreement with Valneva further complements the EU vaccines portfolio, said Commission president, Ursula von der Leyen. “The continuing COVID-19 pandemic in Europe and around the globe makes it more important than ever that all member states have access to the broadest possible portfolio of vaccines,” she said.

EMA to consider approval of AstraZeneca/Oxford COVID-19 vaccine on 29 January

The European Medicines Agency said it has received an application for approval of the COVID-19 vaccine developed by AstraZeneca and Oxford University and will decide on the application on 29 January, during the monthly meeting of its scientific committee for human medicines (CHMP).

The agency said such a short timeframe for evaluation is only possible because it has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed preclinical data, data on quality its ingredients and the way it is manufactured and also considered some evidence on safety and efficacy from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa.

Deliveries of Moderna COVID-19 vaccine begin today

US biotech Moderna said EU deliveries of its COVID-19 vaccine will begin on Monday, 11 January from its central hub in Europe, after the European Commission granted a conditional marketing authorisation for the product on 6 January. Vaccine shipments will be delivered to one pre-agreed central location within each member state, from where each country will coordinate national distribution.

Manufacturing of the vaccine drug substance is carried out by bioprocess specialist Lonza at its site in Switzerland, with filling of vials and packaging done by ROVI in Spain. Further fill and finish capacity will be provided by Recipharm in France in the first half of 2021.

On 18 December last year the Commission exercised an option to order an additional 80 million doses of Moderna’s vaccine against COVID-19, bringing order commitment for 2021 to 160 million doses.

The product has also been authorised for use in the US, Canada, Israel and the UK.

CureVac gets access to Bayer’s pharma expertise for COVID-19 vaccine

German biotech CureVac has secured the heft of German pharma Bayer, as it steers its COVID-19 vaccine through the final stages of clinical testing and onto the market.

Under the terms of the agreement, Bayer will support the further development, supply and key operations around CureVac´s COVID-19 vaccine, contributing expertise and established infrastructure in areas including clinical operations, regulatory affairs, pharmacovigilance, supply chain and support in selected countries.

Stefan Oelrich, president of the Bayer’s pharmaceuticals division said, “We are highly committed to making our capabilities and networks available to help end this pandemic.”

“We are very happy to join forces with Bayer, whose expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible,” said Franz-Werner Haas, CEO of CureVac. “We now also have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals.”

The companies said they plan to combine their strengths to supply hundreds of millions of CVnCoV doses around the world, once approvals are granted.

The European Commission has pre-ordered 225 million doses, and has options to buy 180 million more.

Second COVID-19 vaccine approved by EMA

The European Medicines Agency has recommended approval for US biotech Moderna’s COVID-19 vaccine, which becomes the second vaccine to be approved in the EU.

The European Commission has pre-ordered 160 million doses of the Moderna vaccine, for distribution across the EU.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director of EMA. “As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public.”

The decision is based on a phase III placebo controlled trial involving around 30,000 people.

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine, with 11 of 14,134 vaccinated people contracting symptomatic COVID-19 infections, compared to 185 infections in 14,073 people in the placebo arm. That translates to 94.1% efficacy.

The vaccine also showed 90.9% efficacy in participants at risk of severe COVID-19 infections, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. The high efficacy was also maintained across genders, racial and ethnic groups.

Israel becomes first country outside north America to approve Moderna COVID-19 vaccine

US biotech Moderna said Israel’s Ministry of Health has given its COVID-19 vaccine emergency authorisation and the first of six million doses are expected to be delivered to the country shortly.

This is the third regulatory authorisation for Moderna’s vaccine, and its first outside north America.

Earlier approvals were granted in the US on 18 December and Canada on 23 December. The vaccine is currently under review by the European Medicines Agency and regulators in Singapore, Switzerland and the UK.

At present Moderna has manufacturing capacity in place to produce 600 million doses in 2021, but said it is working to increase this to one billion doses.

EMA experts need more time to decide on Moderna COVID-19 vaccine

A meeting of the European Medicines Agency (EMA) expert committee on human medicines held on Monday failed to conclude its deliberations on whether or not to approve US biotech Moderna’s COVID-19 vaccine. The agency did not issue a formal statement, but said on Twitter that the meeting will continue on Wednesday 6 January.

That follows a defensive statement put out after office hours on 30 December, in which EMA said it needed more data in order to approve the AstraZeneca/Oxford University COVID-19 vaccine, which was approved by the UK Medicines and Healthcare products Agency earlier on the same day.

“Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company,” EMA said.

On 21 December EMA issued a positive opinion, recommending member states approve the Pfizer/Biontech COVID-19 vaccine. At a press briefing called to discuss that decision the new head of EMA, Emer Cooke, said the conditional marketing approval from EMA required greater oversight than emergency authorisations to use the Pfizer/BioNTech vaccine granted elsewhere. It “creates additional obligations for us as a regulatory authority,” she said.

Pfizer and BioNTech will have to conduct post market studies, looking at how long protection lasts, how good the vaccine is at preventing severe COVID-19 disease, and how well it protects people with weakened immune systems, children and pregnant women.

All of EU to get BioNTech vaccine in next five days

German biotech BioNTech said all countries across the European Union that have ordered doses of its COVID-19 vaccine will receive them in the next five days.

In Germany, for example, the company will deliver to 25 distribution centres run by federal states, from where the vaccine will distributed to 294 districts and on to 450 vaccination centres. There will also be 100 mobile vaccination units.

BioNTech also said it expects the vaccine it co-developed with Pfizer to remain effective against the new variant of the SARS-CoV-2 virus that was originally detected in the UK, and which other EU countries with viral genome sequencing programmes, including Denmark and the Netherlands, have since picked up.

The variant is causing concern because it has 23 mutations, including 17 that affect which amino acids the virus produces, and which therefore could have an impact on its behaviour.

An exhaustive programme of research carried out in the UK since the nature of the new variant was confirmed on December 11 show it is more transmissible than other variants that are circulating. However, there is no evidence as yet that it causes more severe disease or that the mutations will prevent vaccines from working.

Research is in progress in the UK to see if plasma from people that have been vaccinated still responds to the new SARS-CoV-2 variant. BioNTech said it is doing similar experiments and expects the results in a couple of weeks, but because its vaccine prompts a very broad immune response it does not expect efficacy to be compromised.

In phase III clinical trials involving 44,000 participants, the vaccine was 95% effective in all subjects and 94% effective in people over the age of 65.

Von der Leyen says immunisation starts next week, after EMA approves Pfizer/BioNTech vaccine

The Pfizer/BioNTech COVID-19 vaccine, approved by the European Medicines Agency on Monday, “Will be available for all EU countries, at the same time, on the same conditions,” said Commission president Ursula von der Leyen, welcoming the approval.

The first batches of vaccine will be shipped from Pfizer's manufacturing site in Belgium within the next few days.

“I have always said, during this pandemic, that we are in this together. So vaccination can start at the same time, during the EU vaccination days, on 27, 28 and 29 December,” von der Leyen said. “This is a very good way to end this difficult year, and to finally start turning the page on COVID-19.”

The first COVID-19 vaccine available in Europe is “a true product of European innovation,” von der Leyen said. BioNTech has received more than €9 million of EU research funding over the past decade and secured a €100 million loan from the European Investment Bank, backed by the EU, in June.

“This helped expand its manufacturing capacities and supply the vaccine quickly worldwide,” said von der Leyen. “This is a true European success story.”

More vaccines will be approved soon, with EMA due to issue its opinion on a second vaccine, developed by US biotech Moderna, on 6 January, von der Leyen promised.

Commission to spend €100M emergency fund money on rapid COVID-19 tests

The Commission has signed a framework contract with Abbott and Roche for the purchase of over 20 million rapid antigen tests for up to €100 million, financed by the emergency support instrument.

These tests will be made available to member states from early 2021, as part of an EU-wide strategy on COVID-19 testing, agreed last week.

Rapid antigen tests offer speed, reliability and quick responses to isolate COVID cases, said health commissioner Stella Kyriakides. “This is crucial to slow down the spread of the pandemic. Testing will remain fundamental in the coming months, even as we aim to start rolling out our vaccines in the EU from 27 December,” she said.

The most reliable method for COVID-19 testing remains the RT-PCR test, but due to increased use, and resulting shortages, and to the relatively high cost and length of time required to produce a result, use of rapid antigen tests in specific settings is increasingly seen as advisable.

Member states are being advised to use rapid antigen tests to further strengthen overall testing capacity, ensuring the tests are conducted by trained healthcare personnel or other trained operators.

EMA brings forward meeting to assess Moderna’s COVID-19 vaccine

The European Medicines Agency said it has scheduled an extraordinary meeting on 6 January 2021 to conclude its assessment of Moderna’s COVID-19 vaccine, if possible. That is a week earlier than expected and followed the submission, ahead of schedule, of the last outstanding package of data needed for the assessment of the application. This contains information specific to manufacturing of the vaccine for the EU market.

“We have been able to revise the timetables for the evaluation of the COVID-19 vaccines due to the incredible efforts of everybody involved in these assessments: the chairs of the scientific committees, the rapporteurs and their assessment teams, scientific experts in all EU member states and my staff at EMA,” said Emer Cooke, EMA’s new executive director.

“The number of infections is increasing across Europe and we are aware of the huge responsibility we have to get a vaccine to the market as quickly as is feasible, whilst maintaining the robustness of our scientific review,” Cooke said.

Earlier this week a US FDA expert committee recommended approval of the Moderna vaccine, making it highly unlikely that EMA will hold back.

The European Commission has signed an advance purchase agreement for 80 million doses of the Moderna vaccine, with an option for a further 80 million doses of the product, which was 94.4% effective in the phase III clinical trial. Moderna is working with Lonza of Switzerland and ROVI of Spain, for manufacturing and fill and finish for Europe.

EMA has also brought forward the meeting of its expert committee to assess the Pfizer/BioNTech COVID-19 vaccine, from 29 December to 21 December.

Commission poised to buy 100M doses of COVID-19 vaccine from US biotech Novavax

The European Commission said it concluded exploratory talks with US company Novavax on purchasing 100 million doses of its COVID-19 vaccine on behalf of member states, with the option to purchase up to 100 million more doses.

President of the European Commission, Ursula von der Leyen, said, “Today's step toward reaching an agreement with Novavax demonstrates the Commission's commitment to ensure all possible options are explored to access vaccines against COVID-19.”

This is the seventh COVID-19 vaccine the Commission has agreed to buy on behalf of member states. Stella Kyriakides, Commissioner for Health said, “All member states must now ensure that they are ready to start deploying some of them as from early 2021, once proven to be safe and effective.”

A phase III trial of the Novavax vaccine being carried out in the UK completed enrollment of 15,000 participants at the end of November. Interim data, expected as soon as early first quarter 2021, are expected to serve as the basis to apply for marketing approval in the UK and the EU.

More than 25% of volunteers in the trial are over the age of 65 and a large proportion have underlying comorbidities.

BioNTech to supply 100M doses of COVID-19 vaccine to China, with first supplies coming from Germany

BioNTech announced an agreement with its Chinese development and commercialisation partner Shanghai Fosun Pharmaceutical, to supply mainland China with an initial 100 million doses of its COVID-19 vaccine in 2021. The first shipments will come from BioNTech’s production facilities in Germany.

“This joint development effort with Fosun Pharma is a testament to the importance of global cooperation and reflects our strategy to supply our vaccine globally,” said Ugur Sahin, CEO and co-founder of BioNTech. “This agreement is an important step toward our shared goal of bringing a safe and efficacious vaccine to people worldwide.”

The COVID-19 vaccine is a successful model of international R&D collaboration, said Wu Yifang, chair and CEO of Fosun Pharma. “We are pleased to reach the supply agreement with BioNTech, which is an important step in Fosun Pharma and BioNTech's efforts to achieve vaccine accessibility and affordability in China.”

The BioNTech vaccine has received emergency use approval from scientifically respected regulators in the UK and the US, where rollout has started, but it is yet to be approved by the European Medicines Agency. Yesterday, the agency said it is bringing forward the meeting of its medicines expert group to decide on approval, from 29 December, to 21 December.

Assuming EMA recommends approval, the European Commission will then fast track its decision-making process (which normally takes 67 days) with a view to granting a marketing authorisation within days.

BioNTech and Fosun Pharma announced their plan to work jointly on the development and commercialisation in China of a COVID-19 vaccine based on BioNTech’s mRNA technology platform earlier this year.

On November 24 the companies started a phase II clinical trial in Jiangsu Province, China, recruiting 960 healthy participants between 18 to 85 years old, to assess the safety and immunogenicity.

French company Valneva starts its first human trial of COVID-19 vaccine in the UK

French biotech Valneva announced the start of the phase I/II clinical study of its COVID-19 vaccine VLA2001, in which the safety and immunogenicity of three dose levels will be assessed in approximately 150 healthy adults.

The trial, to be conducted at sites across the UK, will readout early next year. Subject to analysis of this data, further trials are expected to start immediately thereafter.

Valneva currently plans to include more than 4,000 participants in the additional trials, which it believes could support an initial approval towards the end of 2021.

The UK has a registry where members of the public can volunteer to take part in COVID-19 vaccines trials, to which more than 315,000 people have signed up, meaning studies conducted in the UK have recruited very quickly.

In September 2020, Valneva announced a COVID-19 vaccine partnership with the UK government to provide 60 million doses of VLA2001, which is being manufactured in Scotland. However, VLA2001 is not included in the six vaccines that the European Commission has made advance purchase agreements to buy on behalf of member states.

UK government is investing up front in the scale up and development of Valneva’s vaccine, with the investment being recouped against the vaccine supply.

Thomas Lingelbach, CEO of Valneva said, “While conducting our first clinical trials, we are already ramping up our manufacturing capacities and commencing production at full scale so that we can make the vaccine widely available across the world, assuming the vaccine is safe and effective.”

VLA2001 consists of whole SARS-CoV-2 viruses that have been inactivated, in combination with two adjuvants that boost the immune response. The technology is based on Valneva’s approved vaccine against Japanese encephalitis.

First known case of COVID-19 in a wild animal reported in Utah

The US Department of Agriculture National Veterinary Services Laboratories has reported the presence of SARS-CoV-2, the virus that causes COVID-19, in a free-ranging, wild mink sampled in Utah.

“To our knowledge, this is the first free-ranging, native wild animal confirmed with SARS-CoV-2,” USDA said.

The case has been notified to the World Organisation for Animal Health (OIE). The detection of SARS-CoV-2 in a wild mink was part of the epidemiological study in the area surrounding an infected mink farm.

The USDA Animal and Plant Health Inspection Service conducted wildlife surveillance for SARS-CoV-2 in wild animals around infected mink farms in Utah, Michigan, and Wisconsin, between 24 Aug and 30 Oct 2020.

There is currently no evidence that SARS-CoV-2 is circulating or has been established in wild populations surrounding the infected mink farms. Several animals from different wildlife species were sampled, but all others tested negative.

The sequence of the viral genome obtained from the wild mink was indistinguishable from those obtained from the farmed mink.

The high susceptibility of mink to SARS-CoV-2 has become apparent in countries where they are farmed, with outbreaks reported in Denmark, Netherlands, and the US. This susceptibility has also been demonstrated experimentally.

Delay to GSK/Sanofi COVID-19 vaccine

Sanofi and GlaxoSmithKline announced a delay in their adjuvanted recombinant antigen-based COVID-19 vaccine programme, in order to improve the immune response seen in older adults. This follows phase I/II clinical trial results which showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults, thought to be due to the test vaccine having an insufficient concentration of the antigen.

The companies have updated the European Commission and governments that have contracted to purchase the vaccine, about the delay.

The companies are now planning a phase IIb study that is expected to start in February 2021, which will include a comparison with an authorised COVID-19 vaccine. If data are positive, a phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, delaying the vaccine's potential availability from mid-2021 to Q4 2021.

"We are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine [through to approval]. Following these results and the latest encouraging new preclinical data, we will now work to further optimise our candidate to achieve this goal," said Thomas Triomphe, executive vice president and head of Sanofi Pasteur.

EMA cyberattack exposes Pfizer/BioNTech COVID-19 vaccine data

Pfizer and German biotech BioNTech said they have been informed by the European Medicines Agency (EMA) that the agency has been subject to a cyberattack and that some documents relating to the regulatory submission for the companies’ COVID-19 vaccine BNT162b2, stored on an EMA server, had been unlawfully accessed.

No BioNTech or Pfizer systems were breached in connection with the incident, and the companies said they are not aware that any study participants have been identified through the data being accessed. “At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyberattack will have no impact on the timeline for its review,” the companies said.

EMA published a statement saying it had been the subject of a cyberattack and has launched a full investigation, in close cooperation with law enforcement and other entities. The agency said it cannot provide additional details whilst the investigation is ongoing, and further information will be made available in due course.

Canada becomes third country to approve BioNTech/Pfizer COVID-19 vaccine for emergency use

Pfizer and BioNTech announced the medicines regulator Health Canada has granted authorisation under interim order for the emergency use, of their COVID-19 vaccine, BNT162b2. The companies will supply the Canadian government with a minimum of 20 million doses - and up to 76 million doses - of the vaccine in 2021.

The distribution of the vaccine in Canada will be prioritised according to guidance from the National Advisory Committee on Immunisations. BioNTech will hold the regulatory approval in Canada, while Pfizer will have commercialisation rights.

“Today’s decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada. I’d like to acknowledge the tremendous efforts of Pfizer and BioNTech colleagues around the world who have contributed to the development of this vaccine,” said Cole Pinnow, president, Pfizer Canada.

“It is encouraging to see that our mRNA vaccine is now authorised in Canada. Following UK and Bahrain, it is the third country to approve use of our vaccine within a week,” said Sean Marett, BioNTech’s chief commercial officer. “We are ready to ship the vaccines to Canada as soon as we receive the green light from the regulatory authority to start with the distribution.”

Health Canada’s decision is based on data that was filed through rolling submission and includes data from the phase II/III clinical trial, which began recruiting in late July 2020, enrolling approximately 44,000 people across 150 sites in multiple countries.

JRC releases reference materials to guarantee accuracy of COVID-19 antibody tests

The European Commission's Joint Research Centre (JRC) has released two new reference materials it has developed as quality assurance tools for COVID-19 antibody tests that are used to see if an individual has previously been infected by the virus.

The reference materials enable laboratories to check that antibody tests are functioning correctly. If a test is able to measure the antibodies against COVID-19 present in the reference material, it can also measure the antibodies formed against the virus in human blood. The materials are also a first step in ensuring that the results obtained with different tests are comparable and can support research on immunity against the virus and to help monitor the efficiency of COVID-19 vaccines.

Research commissioner Mariya Gabriel said, “The correct functioning of antibody tests is particularly important in epidemiological investigations to describe the prevalence of the infection and in research on immunity against COVID-19. The reference material developed by the JRC is another piece of the puzzle that can support these efforts.”

Cancer Research UK says research spending slashed in half by pandemic

The charity Cancer Research UK has announced further big cuts, slashing £45 million from its research budget, leaving dozens of projects and hundreds of world-class scientists unfunded.

This is on top of the £44 million cut made to current grants at the start of the pandemic. The new cuts have led to 24 fewer research programmes, 68 fewer projects and 12 fewer fellowships. Cancer Research UK, the biggest funder of cancer research in Europe, says there will be around 328 fewer researchers working on its research.

The axe has fallen on longer-term multi-million-pound research programmes, specific research projects, and fellowships that support scientists at all career stages.

The new cuts are the first phase of the dramatic reduction in research spend the charity previously warned may be necessary. Similar reductions are going to be made at the next funding round in the spring unless the charity’s income gaps are plugged by government support or more charitable giving. If nothing changes, Cancer Research UK could be spending £150 million less per year by 2024, as it faces a potential £300 million decline in fundraising income over the next three years.

Researchers at KU Leuven ready to advance one-dose COVID-19 vaccine into the clinic

Scientists at the Rega Institute at KU Leuven have developed a COVID-19 vaccine, RegaVax that requires only one dose and can be stored in normal fridges. That offers potential advantages over the COVID-19 vaccines arriving on the market first, which each require two doses - weeks apart - and some of which need to be stored in ultra-low temperature fridges.

RegaVax is based on an existing yellow fever vaccine that has been engineered to deliver the genetic code for the spike protein by which the SARS-CoV-2 invades human cells. The same vaccine has been used by the group at as the basis for vaccines against Zika virus, Ebola and rabies.

Preclinical results published this week in the science journal Nature show RegaVax protects hamsters from infection with SARS-CoV-2 after a single dose, and is also effective in monkeys.

"An inexpensive, single-dose vaccine that rapidly protects against infection, that can be stored and transported at fridge temperature, and that may, like the yellow fever vaccine on which it is based, result in long-lasting immunity, provides an important and much-needed diversification of the COVID-19 vaccine landscape," said Johan Neyts, who led the research.

The team is currently preparing for clinical trials and has formed a partnership with a manufacturer to produce the vaccine for these studies.

UK approves Pfizer/BioNTech COVID-19 vaccine

The UK health minister Matt Hancock said he expects the first batch of 800,000 doses of Pfizer/BioNTech’s COVID-19 vaccine to arrive in the country from Belgium in the next few days, after the UK Medicines & Healthcare products Regulatory Agency (MHRA) granted a temporary authorisation for its emergency use. This is the first emergency use authorisation anywhere, following a worldwide phase III trial of the vaccine.

Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days, with the European Medicines Agency having said its scientific committee for human medicines will conclude its assessment during an extraordinary meeting scheduled for 29 December at the latest. The European Commission will then fast track its decision making process with a view to granting a conditional marketing authorisation valid in all EU and EEA member states within days.

“We applaud the MHRA for [its] ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Albert Bourla, CEO of Pfizer. “As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high quality vaccine around the world.”

The MHRA’s decision is based on a rolling submission, including data from the phase III clinical study, which demonstrated a vaccine efficacy rate of 95 per cent from 7 days after the second dose.

In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorised for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021.

Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply and the company will increase its manufacturing capacity in 2021, once a third site in Germany starts up.

The vaccine needs to be stored at minus 80 degrees centigrade and Pfizer has established cold chain infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. Frozen vials will be quickly shipped to designated points of vaccination, minimising the need for long term storage anywhere, and it is not expected the product will need to be stored at any location for more than 30 days.

BioNTech COVID-19 vaccine could be available in Europe before the end of 2020

German biotech BioNTech and partner Pfizer have submitted a formal application for conditional approval of their COVID-19 vaccine to the European Medicines Agency, completing the rolling review process initiated on 6 October. The companies said that if approved the vaccine will be available for use in Europe before the end of 2020.

The submitted data from the phase III trial demonstrated a vaccine efficacy rate of 95 per cent, from seven days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94 per cent. The vaccine, BNT162b2, also showed good tolerability with no safety concerns.

“We stand ready to ship COVID-19 vaccine doses as soon as potential authorisations will allow us,” said Pfizer CEO Albert Bourla.

In addition to submission to EMA, the US FDA and the UK Medicines and Healthcare products Regulatory Agency, the companies have initiated rolling submissions in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies.

Novavax completes enrollment of UK phase III COVID-19 vaccine trial

US biotech Novavax gave an update on its COVID-19 vaccine, NVX‑CoV2373, saying it completed enrollment of 15,000 participants in a pivotal phase III clinical trial being conducted in the UK.

Interim data are now expected as soon as early first quarter 2021, although the timing depends on the overall level of COVID-19 infections. In the week to 29 November, there was an average of 15,222 confirmed cases per day in the UK, though the level of infection is declining due to a four week lockdown, which comes to an end on 4 December.

Novavax said the phase III data are expected to form the basis to file for approval in the UK, EU and other countries. More than 25 percent of volunteers in the trial are over the age of 65, and a large proportion had underlying medical conditions.

Meanwhile, a phase IIb trial taking place in South Africa is also now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 people who are HIV-positive.

Novavax also expects to start a phase III clinical trial in the US and Mexico in the coming weeks and says more than 100 trial sites have been selected.

Vaccine material produced at commercial scale will be used in this study. Novavax was awarded $1.6 billion in funding from the US government’s Operation Warp Speed programme and the money is funding the US and Mexico phase III trial and manufacturing scale-up.

US biotech Moderna submits COVID-19 vaccine for EMA approval

Moderna said it is today submitting its COVID-19 vaccine to the European Medicines Agency for conditional approval, after announcing new data from the phase III study of mRNA-1273.

The second analysis, conducted after 196 volunteers in the trial contracted COVID-19, confirms the efficacy observed at the first interim analysis and indicates vaccine efficacy of 94.1 per cent.

The company also announced it is asking for emergency use authorisation from the US Food and Drug Administration.

The phase III study enrolled more than 30,000 participants in the US. The primary endpoint is based on the number of confirmed COVID-19 cases, starting two weeks after the second dose of vaccine. Of the 196 cases in the latest analysis, 185 were in the placebo group, versus 11 cases in the mRNA-1273 group. A secondary endpoint looked at severe cases of COVID-19, of which all 30 cases occurred in the placebo group. There was one COVID-19-related death, which occurred in the placebo group.

Moderna said efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults, aged 65+, and 42 participants identifying as being from diverse communities. No new serious safety concerns have been identified.

EU and Australia commit to work together to fight pandemic

EU leaders held a virtual meeting with Australian prime minister Scott Morrison today, in which they reconfirmed their resolve to work together to fight COVID-19, agreeing to strengthen bilateral research and innovation cooperation, and to share research data to combat the pandemic.

They also agreed to work together to ensure universal, equitable and early access to safe, effective and affordable COVID-19 vaccines, diagnostics and therapeutics. The EU and Australia have both committed funding to the almost €16 billion raised through the EU-led coronavirus global response pledging marathon.

Charles Michel, president of the European Council, the president of the European Commission, Ursula von der Leyen and Morrison, between them stressed the importance of continued international support for the Access to COVID-19 tools accelerator and the COVAX facility, which will make COVID-19 vaccines available to low income countries.

The leaders also agreed the EU and Australia will continue to work together to strengthen the World Health Organisation, and to improve global preparedness and response to health emergencies.

Commission signs deal for 80M doses of Moderna COVID-19 vaccine

US biotech Moderna announced the European Commission has approved an agreement to secure 80 million doses of its COVID-19 vaccine mRNA-1273.

Under the terms of the agreement, the commission has the option to increase its purchase from 80 million doses to a total of up to 160 million doses. The value of the contract was not disclosed.

The agreement will be finalised following a review by member states. Delivery of the vaccine could begin by the first quarter 2021 if it is approved for use by the European Medicines Agency, which started a rolling review of mRNA-1273 on November 17.

In Europe, Moderna is working with partners Lonza of Switzerland and ROVI of Spain, for manufacturing and fill and finish outside the US. This is a dedicated supply chain to support Europe and countries other than the US. The company says it is on track to manufacture 500 million to 1 billion doses globally in 2021.

On November 16, Moderna announced that the independent data safety monitoring board for the phase III study said the trial had met the pre-specified statistical criteria and mRNA-1273 has efficacy of 94.5 per cent.

Russia’s Sputnik COVID-19 vaccine more than 90% effective, according to new phase III analysis

The second interim analysis of the phase III clinical trial data of the Russian COVID-19 vaccine Sputnik V, showed it is 91.4 per cent effective.

The calculation was based on the analysis of data on 18,794 volunteers who received both the first and second doses of the Sputnik V (the V stands for vaccine) or placebo, at the second control point, of 39 confirmed cases of COVID-19 infection as of November 23, 2020.

That analysis was made seven days after volunteers received the second dose of the vaccine. Preliminary data from volunteers 21 days after the second dose indicates efficacy is above 95 per cent.

The Russian Direct Investment Fund, the sovereign wealth fund that is funding development of the vaccine, said the cost in international markets will be less than US$10 per dose for the two dose vaccine. The fund currently has agreements in place with foreign pharmaceutical companies to manufacture 1 billion doses and is assessing other applications to further increase production capacity. The vaccine will be free for Russian citizens.

Currently, 40,000 volunteers are taking part in the phase III double-blind, randomised, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia. There were no unexpected adverse events and monitoring of the participants is ongoing.

Sputnik V is based on a human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades. More than 100,000 people have received approved and registered drugs that use inactivated human adenoviruses, which cause the common cold, as the therapeutic delivery vehicle.

AstraZeneca/Oxford University COVID-19 turns in positive phase III results

The interim analysis of the phase III interim trial of AstraZeneca/Oxford University’s COVID-19 vaccine, conducted after 131 people in the trial contracted the infection, shows it is 70.4 per cent effective when combining data from two dosing regimens. In the two different regimens vaccine efficacy was 90 per cent in one, when the immune system was primed with a half dose, followed by a full dose, compared to 62 per cent in those receiving two full doses.

There early signs that the vaccine could reduce virus transmission and serious disease, with no hospitalised or severe cases in anyone who received the vaccine.

AstraZeneca and the researchers at Oxford University are stressing a critical attribute of their vaccine, which is that it can be easily administered in existing healthcare systems, being stored at fridge temperature of 2-8 °C and distributed using existing logistics.

Large scale manufacturing is ongoing in over 10 countries to support equitable global access, and AstraZeneca said the safety and efficacy data will now be submitted to the European Medicines Agency, the UK Medicines and Healthcare products Agency and other regulators for approval.

Andrew Pollard, director of the Oxford vaccine group and chief investigator of the Oxford trial, said, “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90 per cent effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”

Phase II data from AstraZeneca/Oxford University COVID-19 vaccine shows it stimulates strong immune response in the elderly

The AstraZeneca/Oxford University COVID-19 vaccine shows similar safety and strength of immune response in people aged 56 years and over to that seen in adults aged 18-55 years, according to phase II results published today in The Lancet.

The phase II trial found the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups and at low and standard dose, provoking a T cell response within 14 days of the first dose and an antibody response within 28 days of the booster dose of vaccination. Phase III trials are ongoing to confirm these results - as well as how effective the vaccine is in protecting against COVID-19 infection – in a broader range of people, including older adults with underlying health conditions.

The study is the fifth published clinical trial of a vaccine against COVID-19 tested in an older adult population. One study has shown similar immune responses in young and old adults (Moderna mRNA vaccine), while other trials have suggested lower responses in older adults, compared to younger adults receiving the same vaccine (CanSino single dose adenovirus-vector vaccine; Pfizer/BioNTech mRNA vaccine; and SinoPharm/Beijing Institute of Biological Products inactivated viral vaccine).

First COVID-19 vaccine to finish phase III trial is 95% effective

German biotech BioNTech and partner Pfizer announced that after conducting the final efficacy analysis in the phase III study, their COVID-19 vaccine, BNT162b2, met all of the study’s primary efficacy endpoints, with an efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection. The analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent.

There were ten severe cases of COVID-19, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. The vaccine was well tolerated, with most adverse events resolving shortly after vaccination.

The safety milestone required by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved and Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA. The data will also be submitted to other regulatory agencies around the world.

The phase III clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42 per cent of global participants and 30 per of US participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of US participants are 56-85 years of age. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer said it is confident its existing cold chain infrastructure will be fit for distributing the vaccine, which needs to be keep at minus 70 degrees centigrade. The companies have developed specially designed temperature-controlled thermal shippers using dry ice to maintain temperature control. The shippers can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer review in a scientific journal once analysis of the data is completed.

EMA starts rolling review of Moderna’s COVID-19 vaccine

Moderna announced that the European Medicines Agency (EMA) has started a rolling review of mRNA-1273, its vaccine against COVID-19, after confirmation the product was eligible to be submitted for approval on 14 October. The rolling review was accepted by EMA based on preclinical, clinical and manufacturing data available to date.

That followed the announcement on Monday that the independent, data safety monitoring board for the phase III study of mRNA-1273 had informed Moderna the vaccine shows efficacy of 94.5 per cent.

Moderna said it is now scaling up global manufacturing with Lonza of Switzerland and ROVI of Spain to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.

Commission announces deal for 405M doses of Curevac’s COVID-19 vaccine

The European Commission has signed an advance purchase agreement on behalf of member states to buy up to 405 million doses of the COVID-19 vaccine being developed by German biotech CureVac.

This follows on from the commission and the European Investment Bank providing funding for CureVac to support development of the vaccine. Ursula von der Leyen, commission president said if it is safe and effective, every member state will receive the vaccine at the same time, on a pro-rata basis.

This is the fifth contract for the EU’s COVID-19 vaccines portfolio. Von der Leyen said a sixth is under negotiation with US biotech Moderna, which yesterday announced that an interim analysis of the US phase III trial showed its vaccine was 94.5 per cent effective.

Last week the European Commission approved a fourth contract, with BioNTech and Pfizer, for the initial purchase of 200 million doses, plus an option to request up to a further 100 million doses, for their vaccine, which was also shown to be effective in the interim phase III analysis.

Before that, contracts were signed with Sanofi/GlaxoSmithKline, AstraZeneca and Johnson & Johnson.

Moderna announces its COVID-19 vaccine is 94.5% effective

Moderna said the independent safety board monitoring the phase III study of mRNA-1273, its COVID-19 vaccine, has informed Moderna the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with efficacy of 94.5 per cent. The study has enrolled more than 30,000 participants in the US.

The primary endpoint of the phase III study is based on the analysis of COVID-19 cases confirmed starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases in the mRNA-1273 group.

A secondary endpoint analysed severe cases of COVID-19, and included 11 severe cases, which all occurred in the placebo group, with none in the mRNA-1273 vaccinated group.

A concurrent review of the available phase III safety data did not report any significant safety concerns.

UK to invest £12.2M in real time COVID-19 genomic surveillance system

The Wellcome Sanger Institute in Cambridge and the COVID-19 Genomics UK (COG-UK) consortium have been awarded £12.2 million to expand whole genome sequencing of SARS-CoV-2 virus samples, to map how COVID-19 spreads and evolves in real time.

As part of the genomic surveillance system, researchers at the Sanger will develop surveillance software to help public health authorities detect and respond to local outbreaks faster and monitor for any viral mutations associated with escape from vaccines once they are deployed.

Since March 2020, COG-UK has sequenced and made publicly available more than 100,000 SARS-CoV-2 genomes, making up over 45 per cent of the global total. This unprecedented effort has not been achieved previously for any pathogen, anywhere in the world.

The current second wave of COVID-19 infections throughout Europe means it is important that genomic tracking of the virus is supported for the long term. The genomic data will be used in genomic surveillance of the virus as new vaccines are deployed, to determine whether the virus evolves to escape them.

New UK survey finds most people would accept a COVID-19 vaccine

With concerns about vaccine denial on the rise across Europe and elsewhere, a survey carried out by the London School of Hygiene & Tropical Medicine has found that nine out of ten parents and guardians in England would accept a COVID-19 vaccine for themselves and their children

Fewer than 4 per cent of respondents said they would definitely not accept a COVID-19 vaccine for themselves or their child/children.

Sadie Bell, research fellow at LSHTM and lead author said, “COVID-19 vaccines will be key to controlling this pandemic. Encouragingly, it’s looking likely that one will be available in 2021. However, having a vaccine doesn’t mean people will take it - vaccine hesitancy is a multi-faceted and complicated issue.

“To prevent inequalities in uptake, it is crucial to understand and address factors that may affect COVID-19 vaccine acceptability in ethnic minority and lower-income groups which are disproportionately affected by COVID-19.”

The survey revealed the main motivation for vaccine acceptance was for self-protection from COVID-19. Other reasons were to protect others, including family members and someone known to them in a risk group for COVID-19, and to stay safe to look after their children.

Study co-author Pauline Paterson, assistant professor and co-director of the Vaccine Confidence Project, said, “While it is great to see that most parents and guardians would accept a COVID-19 vaccine, our research has revealed worrying disparities. We know ethnic minority and lower-income groups are disproportionally affected by COVID-19, so it’s imperative that health officials focus on strategies to boost vaccine confidence in these communities.”

EU scientific advisers issue recommendations for better pandemic preparedness

Learning the lessons of COVID-19, the European Commission’s scientific advisers have published recommendations for pre-empting and controlling emerging diseases. They are calling for better coordination between member states during pandemics, along with other moves to improve Europe’s ability to respond to such a crisis in future.

Among these measures, the EU should set up a body to advise on health threats and crises, and establish a joint early-response mechanism for pandemics, the experts say. Their report also underlines the need for research to be coordinated, as was the case with the ERAvsCorona plan, which set out a short-term framework for coordinating national and EU research activities at the beginning of the COVID-19 crisis.

The recommendations put forward by members of the commission’s independent group of chief scientific advisers, the European group on ethics in science and new technologies, and Peter Piot, Director of the London School of Hygiene and Tropical Medicine, who is special adviser to commission president Ursula von der Leyen on the response to the COVID-19 crisis, informed the commission's proposal to create a European health union announced on Wednesday.

Read more about what the chair of the expert group, Rolf-Dieter Heuer, has to say about the work of scientific advisers here.

Commission announces plans for European Health Union

The European Commission today put forward proposals for a European health union, following criticism of the lack of a coordinated response to the COVID-19 pandemic this spring.

“We all witnessed the effects of the uncoordinated national measures during the first weeks and even months of the outbreak,” said EU health commissioner Stella Kyriakides. “With today’s proposals, we are taking the first steps towards a European health union, giving us stronger legislation to act and support member states in situations of serious cross-border threats.”

The proposals set out a new regulation on serious cross-border threats to health, which will strengthen EU health crisis preparedness, reinforce surveillance of emerging diseases and facilitate data sharing between member states.

The commission wants to set up a new agency modelled on the US Biomedical Advanced Research and Development Authority, as announced by the commission president Ursula von der Leyen in September. The agency, to be called the Health Emergency Response Authority, will be responsible for supporting development of new drugs, by horizon scanning to see what products are coming through to the clinic, tracking emerging biomedical trends, promoting access to medicines and medical equipment, and increasing manufacturing capacity.

The commission also proposes to reinforce the European Centre for Disease Control and Prevention (ECDC) and the European Medicines Agency (EMA).

Setting up of preparedness plans and stress testing national healthcare systems will be funded by the €5.1 billion EU4Health programme, while funding for other initiatives will come from the investment programme, InvestEU.

Pfizer and BioNTech formalise agreement to supply EU with 200M doses of COVID-19 vaccine

Pfizer and BioNTech today announced that they have reached an agreement with the European Commission to supply 200 million doses of their COVID-19 vaccine, with deliveries expected to start before the end of the year from manufacturing plants in Belgium and Germany.

The commission also has an option on a further 100 million doses. The European Medicines Agency is conducting a rolling review of the safety and efficacy data, and assuming it is approved, the European Commission will lead the process of allocating vaccine doses among the EU member states which have elected to buy the vaccine as part of this agreement.

The value of the contract was not disclosed. The only published price is a $1.95 billion contract with the U.S. government for an initial 100 million doses. The cost of $19.50 per dose is a benchmark for developed countries, Ugur Sahin, co-founder and CEO of BioNTech said when presenting the company’s third quarter results on 10 November. The vaccine requires two doses to be effective.

“Today’s finalised supply agreement with the European Commission represents the largest initial order of vaccine doses for Pfizer and BioNTech to date,” said Albert Bourla, chairman and CEO of Pfizer.

Pfizer and BioNTech announced the conclusion of initial talks with the commission to supply doses of the vaccine, if approved, on September 9, 2020. The proposed supply agreement is now final.

On November 9, 2020, the two companies announced an interim analysis of the phase III trial showed the vaccine was 90 per cent effective in preventing COVID-19 infection.

European Centre for Disease Control to issue guidance on COVID-19 in Danish mink farms

Denmark’s infectious disease control agency Statens Serum Institut has been in discussions with the European Centres for Disease Prevention and Control, about the mutated forms of the SARS-CoV-2 virus that have been transmitted from minks to humans on farms in North Jutland. ECDC expects to publish a risk assessment next week.

SSI also said it has published the entire gene sequence of the mutated viruses on the international public database GISAID, after coming under criticism from researchers around the world for not doing so. GISAID has been publishing viral sequences since the beginning of the pandemic, making it possible to see how and where the virus is spreading and the rate at which it is evolving.

Last week, the Danish government ordered the culling of all 17 million mink being raised on more than 1,000 farms in the country.

German biotech BioNTech says it has submitted COVID-19 vaccine for EMA approval

BioNTech confirmed it has submitted its COVID-19 vaccine for review by the European Medicines Agency, the UK Medicines and Healthcare products Agency, and the Canadian regulator Health Canada. The company also confirmed it expects to file for emergency use authorisation in the US before the end of November. This follows announcement of interim results from the phase III trial showing the vaccine is 90 per cent effective in preventing people getting infected with the virus.

BioNTech and its partner Pfizer currently have firm orders for 570 million doses in 2020 and 2021, with the EU having ordered 200 million doses with an option for an additional 100 million doses

Biden-Harris transition announces COVID-19 advisory board

The Biden-Harris Transition has announced the formation of the Transition COVID-19 advisory board, a team of public health experts who will advise president-elect Joe Biden, vice president-elect Kamala Harris, and the Transition’s COVID-19 staff. The Transition COVID-19 advisory board will be led by co-chairs David Kessler, Vivek Murthy, and Marcella Nunez-Smith. Beth Cameron and Rebecca Katz will serve as advisors.

“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” said Biden. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”

Biden has pledged to bring leadership to the COVID pandemic, by curbing the spread of the disease, providing free treatment to those in need, and elevating the voices of scientists and public health experts. The COVID-19 Advisory Board will consult state and local officials to determine the public health and economic steps necessary to get the virus under control.

BioNTech and Pfizer say their COVID-19 vaccine is 90% effective in phase III

German biotech BioNTech and US pharma Pfizer have announced their COVID-19 vaccine candidate, BNT162b2, has been shown to have an efficacy rate above 90 per cent, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of vaccination, which consists of a two-dose schedule. The independent data monitoring committee has not reported any serious safety concerns and recommends the ongoing phase III study continues to collect additional safety and efficacy data as planned.

“The first set of results from our phase III COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Albert Bourla, Pfizer chairman and CEO. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

“This is a victory for innovation, science and a global collaborative effort,” said Ugur Sahin, BioNTech co-founder and CEO. “We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.”

The phase III clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom had received a second dose of the vaccine candidate as of 8 November. The trial is continuing to enroll. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention of severe COVID-19 disease.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorisation – will be available by the third week of November.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the safety and manufacturing data to submit to the FDA. The companies expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021.

Denmark orders mass mink cull over COVID-19 mutations

The Danish government ordered up to 15 million mink to be culled after evidence that mutated forms of the SARS-CoV-2 virus have spread from farmed animals to humans.

The variants coming from mink have been shown to have mutations affecting the spike protein through which the virus infects humans. This is the protein on SARS-CoV-2 that is targeted by most of the COVID-19 vaccines currently in development, and Danish prime minister Mette Frederiksen said there are concerns it could undermine the effectiveness of vaccines if it spreads further in humans.

In a risk assessment, the Danish infectious diseases control agency, Statens Serum Institut, found that the mink-derived virus exhibited decreased susceptibility to neutralising antibodies from the blood of several people who had recovered from COVID-19 infection. In addition, a large virus reservoir in mink increases the chances that further mutations will arise, and that there will be more transmission of these variants to humans.

Since the beginning of August 2020, 168 mink farms have been infected in North Jutland - all with the SARS-CoV-2 mink variant. In parallel, there is an increasing incidence of the mink variant among citizens in the region, with approximately half of infections due to the SARS-CoV-2 mink variant.

Denmark is the biggest producer of mink fur in the world, selling around 17 million pelts per annum.

Europe back in the grip of pandemic as cases rise by 22% in the past week

The European region has seen a 22 per cent increase in new cases of COVID-19 and a 43 per cent increase in deaths in the past seven days compared with the previous week, according to the latest data from the World Health Organisation (WHO).

At a global level, Europe reported half of new cases, with over 1.7 million positive tests. There were 17,000 deaths.

France, Italy, and the UK reported the highest numbers of new cases, although Andorra, the Czech Republic and Belgium reported the highest per population incidence. France accounted for the third highest number of new cases globally, with over 275,000 positive tests reported in the past week (4,200 cases per million population). That is an increase of 27 per cent from the previous week.

New cases in Belgium fell by 21 per cent from last week to 82,500, while those in Italy rose by 72 per cent from last week to 175,000 new cases.

Despite the fall seen in Belgium, it still has one of the world’s highest incidences of the infection, with 7,000 new cases per million population. Italy’s incidence is lower at 2,800 cases per million.

In Switzerland, the number of new cases grew considerably in October, rising from fewer than 2,500 per week reported from mid-April through to the end of September - and fewer than a hundred cases reported in some weeks - to 50,000 new cases in the past week. Switzerland has the fifth-highest incidence of new cases in the region, at 5,800 cases per million population.

While weekly testing rates have increased in Switzerland, test positivity rates have also increased from 15 per cent to 22.5 per cent, as of 25 October.

In the past week, over 3.3 million new cases of COVID-19 infection have been reported globally. As of 1 November, nearly 46 million cases and 1.2 million deaths have been reported to WHO.

COVID-19 pandemic is creating insecurity about future science funding

COVID-19 has created a sense of uncertainty about research funding, according to a survey of more than 25,000 scientists in 152 countries, with 47 per cent of respondents saying less funding will be available in the future as a result of COVID-19, signalling a potentially lasting effect.

"The impact of COVID-19 is manifesting itself across the funding landscape. While it is critical that collectively, we do everything we can right now to combat the virus, we must also recognise that diverting or the 'covidisation' of funding away from other fields is not a sustainable solution,” said Kamila Markram, CEO and co-founder of the open access academic publisher Frontiers, which carried out the survey. “The environment, for example, is an area we simply cannot afford to neglect.”

The survey found researchers are divided over their perceptions of government responses to the pandemic. Those that showed a significantly higher level of dissatisfaction with policy makers' use of scientific advice during the pandemic include the US, Brazil, Chile and the UK, while those in New Zealand, China, and Greece were the most satisfied.

"While we do not know what advice was given and if it was used, this data suggests more comfort in those countries that are coping well, those who took early lockdown decisions, have had similar previous experience, for example with SARS, and who recognised science as key to pandemic management decision making,” said Peter Gluckman, chair of the International Network for Government Science Advice.

The survey to assess the initial impact of the coronavirus pandemic on scientists was conducted by Frontiers between May and June.

“Scientists are under extraordinary pressure to deliver answers and a lack of precedent and preparation, combined with severe political and social pressures, has made this an incredibly challenging time for them,” said Markram. “Along with the disruption faced by most of the world's population - lockdown, remote working, isolation and anxiety - many researchers have felt an added pressure to understand, cure and mitigate the virus."

The survey shows scientific research has been able to continue for the large part, despite the disruption of COVID-19. When asked what they had been working on during the pandemic, 74 per cent of respondents said writing papers, 57 per cent continued with their research, and 42 per cent did virtual teaching.

Director General of the World Health Organisation in quarantine

The head of the WHO Tedros Ghebreyesus is in quarantine after coming into contact with someone with a confirmed COVID-19 infection.

“I have been identified as a contact of someone who has tested positive for COVID-19. I am well and without symptoms, but will self-quarantine in the coming days, in line with WHO protocols,” Ghebreyesus said in his media briefing on Monday.

COVID-19 drug found by supercomputer to start clinical trial in Italy

One of the drugs identified by the EU-funded supercomputing consortium Exscalate4CoV as having potential to treat COVID-19 infections, has now received approval for a 450 patient trial in Italy.

Raloxifene, approved for the treatment of the bone thinning disorder osteoporosis, was found to have antiviral properties. It will be tested in patients who have mild COVID-19 symptoms.

Exscalate4CoV screened 400,000 molecules in silico, selecting 7,000 for testing in the laboratory. The work was funded by a €3 million EU Horizon 2020 grant. A patent on the use of raloxifene for the treatment of people infected by COVID-19 was filed on 6 May 2020 by the Italian pharma company Dompé farmaceutici, the Fraunhofer Institute and Leuven University. They say the aim is to promote universal access to therapies that may be developed by Exscalate4CoV.

Sanofi and GlaxoSmithKline sign COVID-19 vaccine procurement deal with COVAX

Sanofi and GlaxoSmithKline have committed to make 200 million doses of their COVID-19 vaccine available through the COVAX vaccines distribution mechanism set up by the World Health Organisation, if the vaccine is approved.

COVAX was set up to ensure rapid, fair and equitable access to COVID-19 vaccines. As of mid-October, 92 richer countries, including the EU27, have signed up to pay for vaccines procured through COVAX, for their own populations, and to make donations to 92 lower income countries. The mechanism is being overseen and co-led by GAVI, the global vaccines alliance, and CEPI, the Coalition for Epidemic Preparedness Innovations.

COVAX aims to procure, equitably allocate and deliver two billion doses of safe and effective COVID-19 vaccines by the end of 2021. Seth Berkley, GAVI CEO said, “Gavi is seeking to secure doses of the most promising vaccine candidates – so that the 184 participants involved in the COVAX Facility can make sure their most at-risk groups, such as healthcare workers, have rapid access to doses of a safe and effective vaccine. That is the world’s best chance to end the acute stage of this pandemic, and we encourage other vaccine manufacturers to work with us towards that shared global goal.”

As of 6 October, COVAX had received pledges of $1.7 billion to procure COVID-19 vaccines for donating to poorer countries.

Call for UK government support for medical research charities hit by COVID-19

The Institute for Public Policy Research (IPPR) published its Research at Risk report, warning the hit to charity fundraising from COVID-19 could mean up to £7.8 billion less for medical research in the UK between now and 2027.

Medical research charities that rely on events and high street shops for much of their funding have seen a 40 per cent fall in income as a result of the pandemic.

IPPR modelling predicts that lost charity income could mean, in a worst-case scenario, that medical research charities invest £4.1 billion less in health R&D between now and 2027. That is predicted to have a knock-on effect on private investment in collaborative research, which could fall by as much as £1.3 billion.

An additional fall in private investment, due to adverse economic conditions, of £2.5 billion, puts £7.8 billion of medical research investment is at risk. IPPR says the government should introduce a new, three year life sciences charity fund, equal to the shortfall in medical charity income caused by Covid-19 and lasting for three years. Charities should be free to use this fund as needed to maintain their R&D portfolios.

This matches an earlier call by Aisling Burnand chief executive of the Association of Medical Research Charities, a body representing160 charities that between them put £1.9 billion into R&D in 2019. “Looking at the years ahead, not only will there be a drastic shortfall in charity funded research, but the knock on impact on levels of private R&D investment will be sizable,” Burnand said. “The IPPR Research at Risk report gives a strong economic rationale for the proposed Life Sciences Charity Partnership Fund.”

Von der Leyen calls for new mindset on health as Europe faces next phase of pandemic

The world needs to change its mindset on health, moving away from thinking only about individual clinical outcomes, European Commission president Ursula von der Leyen told the World Health summit in a speech on Sunday. “In today's world, we need to look after our health by looking after our planet, our wellbeing and our sustainable development,” von der Leyen said.

She was speaking as the next phase of the COVID-19 pandemic tightens its grip. “The dramatic spikes in recent weeks across the world and especially here in Europe reflect a picture that is getting worse by the day,” said von der Leyen. “We are back to March and April levels and in many cases already far beyond it.”

But while the virus is back stronger than ever, knowledge and experience of how to control it is also much better than before, she said. One case in point is the ability to coordinate across borders, with the EU having carried out research that forms the basis of common criteria and thresholds when deciding whether to introduce travel restrictions, and a single set of rules for testing and quarantining people.

Last week, the EU set up a gateway allowing national COVID-19 contract tracing apps to interoperate. Tracing apps from Germany, Ireland and Italy are now linked to this gateway, with the Czech Republic, Denmark, Latvia, Spain and others, due to link up.

Building on these measures, von der Leyen pledged to put in place an EU-wide strategy to centrally collect data and evidence to assess the impact, effectiveness and any side effects, if and when any COVID-19 vaccines are approved. “Preparations for these activities must start now to be in place when COVID-19 vaccines reach the EU market,” she said.

In addition, the commission will be putting forward proposals to improve and strengthen the European Medicines Agency and the European Centre for Disease Control, and to set up a new European agency for biomedical advanced research and development. “We will build the foundations of a stronger European health union in which 27 countries work together to detect, prepare and respond collectively,” said von der Leyen.

COVID-19 will have a long-lasting impact on universities, report shows

The European Universities Association (EUA) today released a report suggesting that the COVID-19 pandemic will have a long-lasting effect on universities which will need adequate support from public authorities to weather the crisis.

The report says universities suffered immediate losses due to the interruption of services, research contracts and international student recruitment. At the same, they now need to invest in better digital infrastructure for online learning and to adapt campuses to new health regulations.

“There are high levels of uncertainty and great concern in projections about future income from both public and private sources,” said Thomas Estermann, the EUA’s director of governance, funding and public policy development. “However, on a positive note, greater trust in universities due to their prominent role in crisis recovery is an asset – and we can capitalise on that.”

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