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.
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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.
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.
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.
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.
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.
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 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 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.
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.
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.