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.
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.
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.
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.
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.