21 Jan 2021

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

Covid 19 blog

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.

You can read the full archive of this blog here.

 

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.

 

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.

 

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.”

 

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.

 

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 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.

 

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.

 

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

 

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.

 

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.

 

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