LIVE BLOG: R&D response to COVID-19 pandemic (archived)

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.

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.

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.

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.”

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.