- Analysis of waste water in Gothenburg shows extent of Omicron spread
- AstraZeneca says booster doses of its COVID-19 vaccine are effective against variants – including Omicron
- EMA and other regulators meet to agree requirements for adapted COVID-19 vaccines
- New method analyses SARS-CoV-2 sequence data to predict which variants are high risk
The coronavirus pandemic is disrupting universities and research institutes across the world. But the same institutions are also working very hard to find out how the disease can be stopped and its effects mitigated.
Follow this live blog for the latest updates on how the crisis is impacting research and innovation, and what governments, funders, companies, universities, associations and scientists are doing to stop or cope with the pandemic.
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC).
However, additional doses should be considered for people with severely weakened immune systems as part of their primary vaccination.
Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU are currently highly protective against COVID-19-related hospitalisation, severe disease and death.
At the same time, about one in three adults over 18 years is still currently not fully vaccinated. “In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course,” the European Medicines Agency said in a statement.
EMA is currently assessing data on booster doses, and said while it does this member states “may consider preparatory plans for administering boosters.”
The first of the so-called second wave of COVID-19 vaccines, which have been designed from the ground up to be more accessible and affordable, has started a phase III clinical trial.
The vaccine, GBP510, developed by South Korean biotech SK Bioscience, will be administered in combination with an adjuvant from GlaxoSmithKline (GSK), which is intended to increase the immune response.
The randomised global trial will enrol around 4,000 participants from a range of countries to evaluate GBP510's safety and immunogenicity compared to the AstraZeneca/Oxford University COVID-19 vaccine. The study will be one of the first global phase III trials to directly compare two different COVID-19 vaccines.
"We are grateful that we were able to advance to the phase III study with the unprecedented support of global initiatives, including GSK, the Coalition for Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda Gates Foundation,” said Jaeyong Ahn, CEO of SK Bioscience.
“While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world,” said Thomas Breuer, chief global health officer at GSK.
The move to phase III follows positive interim phase I/II data which showed that all participants who received the adjuvanted vaccine developed strong neutralising antibody responses, demonstrating a 100% seroconversion rate. Neutralising antibody levels were between five and a maximum of eight times higher than in people who had recovered from COVID-19.
The vaccine is being developed by SK Bioscience in collaboration with the Institute for Protein Design at the University of Washington, with $213 million funding from the Gates Foundation and CEPI as part of the 'Wave 2' vaccine investment project to develop more accessible and affordable COVID-19 vaccines.
Results from the phase III study are expected in the first half of 2022.
People infected with the SARS-CoV-2 Delta variant that is now causing most infections across Europe and the rest of the world have approximately double the risk of hospitalisation compared with those infected with the Alpha variant that was dominant from December to May, according to a study of more than 40,000 cases from England between 29 March and 23 May 2021, published in The Lancet Infectious Diseases.
Around one in 50 patients in the study was admitted to hospital within 14 days of their first positive COVID-19 test. After accounting for factors that are known to affect susceptibility to severe illness from COVID-19, including age, ethnicity, and vaccination status, the researchers found the risk of being admitted to hospital was more than doubled with the Delta variant compared with the Alpha variant.
The study is the first to report hospitalisation risk for the Delta versus Alpha variants based on cases confirmed by whole genome sequencing, which is the most accurate way to determine which variant is involved.
The Delta variant was first reported in India in December 2020 and early studies found it to be up to 50% more transmissible than the Alpha variant of COVID-19 that had previously gained dominance worldwide, after it was first identified in Kent, UK.
During the study period, there were 34,656 cases of the Alpha variant (80%) and 8,682 cases of the Delta variant (20%). While the proportion of Delta cases in the study period overall was 20%, it grew to account for around two thirds of new COVID-19 cases in the week starting 17 May 2021, indicating it had overtaken Alpha to become the dominant variant in England.
The study demonstrates the effectiveness of COVID-19 vaccines. Only 1.8% of people hospitalised with either variant had received both doses of a vaccine; 74% of cases were unvaccinated, and 24% had received one dose.
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.
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.
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.”
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.
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.
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.
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.