18 Nov 2020

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.

 

The interim analysis of the phase III interim trial of AstraZeneca/Oxford University’s COVID-19 vaccine, conducted after 131 people in the trial contracted the infection, shows it is 70.4 per cent effective when combining data from two dosing regimens. In the two different regimens vaccine efficacy was 90 per cent in one, when the immune system was primed with a half dose, followed by a full dose, compared to 62 per cent in those receiving two full doses.

There early signs that the vaccine could reduce virus transmission and serious disease,  with no hospitalised or severe cases in anyone who received the vaccine.

AstraZeneca and the researchers at Oxford University are stressing a critical attribute of their vaccine, which is that it can be easily administered in existing healthcare systems, being stored at fridge temperature of 2-8 °C and distributed using existing logistics.

Large scale manufacturing is ongoing in over 10 countries to support equitable global access, and AstraZeneca said the safety and efficacy data will now be submitted to the European Medicines Agency, the UK Medicines and Healthcare products Agency and other regulators for approval.

Andrew Pollard, director of the Oxford vaccine group and chief investigator of the Oxford trial, said, “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90 per cent effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”

 

The AstraZeneca/Oxford University COVID-19 vaccine shows similar safety and strength of immune response in people aged 56 years and over to that seen in adults aged 18-55 years, according to phase II results published today in The Lancet.

The phase II trial found the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups and at low and standard dose, provoking a T cell response within 14 days of the first dose and an antibody response within 28 days of the booster dose of vaccination. Phase III trials are ongoing to confirm these results - as well as how effective the vaccine is in protecting against COVID-19 infection – in a broader range of people, including older adults with underlying health conditions.

The study is the fifth published clinical trial of a vaccine against COVID-19 tested in an older adult population. One study has shown similar immune responses in young and old adults (Moderna mRNA vaccine), while other trials have suggested lower responses in older adults, compared to younger adults receiving the same vaccine (CanSino single dose adenovirus-vector vaccine; Pfizer/BioNTech mRNA vaccine; and SinoPharm/Beijing Institute of Biological Products inactivated viral vaccine).

 

German biotech BioNTech and partner Pfizer announced that after conducting the final efficacy analysis in the phase III study, their COVID-19 vaccine, BNT162b2, met all of the study’s primary efficacy endpoints, with an efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection. The analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent.

There were ten severe cases of COVID-19, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. The vaccine was well tolerated, with most adverse events resolving shortly after vaccination.

The safety milestone required by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved and Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA. The data will also be submitted to other regulatory agencies around the world.

The phase III clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42 per cent of global participants and 30 per of US participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of US participants are 56-85 years of age. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer said it is confident its existing cold chain infrastructure will be fit for distributing the vaccine, which needs to be keep at minus 70 degrees centigrade. The companies have developed specially designed temperature-controlled thermal shippers using dry ice to maintain temperature control. The shippers can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer review in a scientific journal once analysis of the data is completed.

 

Moderna announced that the European Medicines Agency (EMA) has started a rolling review of mRNA-1273, its vaccine against COVID-19, after confirmation the product was eligible to be submitted for approval on 14 October. The rolling review was accepted by EMA based on preclinical, clinical and manufacturing data available to date.

That followed the announcement on Monday that the independent, data safety monitoring board for the phase III study of mRNA-1273 had informed Moderna the vaccine shows efficacy of 94.5 per cent.

Moderna said it is now scaling up global manufacturing with Lonza of Switzerland and ROVI of Spain to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.

 

The European Commission has signed an advance purchase agreement on behalf of member states to buy up to 405 million doses of the COVID-19 vaccine being developed by German biotech CureVac.

This follows on from the commission and the European Investment Bank providing funding for CureVac to support development of the vaccine. Ursula von der Leyen, commission president said if it is safe and effective, every member state will receive the vaccine at the same time, on a pro-rata basis.

This is the fifth contract for the EU’s COVID-19 vaccines portfolio. Von der Leyen said a sixth is under negotiation with US biotech Moderna, which yesterday announced that an interim analysis of the US phase III trial showed its vaccine was 94.5 per cent effective.

Last week the European Commission approved a fourth contract, with BioNTech and Pfizer, for the initial purchase of 200 million doses, plus an option to request up to a further 100 million doses, for their vaccine, which was also shown to be effective in the interim phase III analysis.

Before that, contracts were signed with Sanofi/GlaxoSmithKline, AstraZeneca and Johnson & Johnson.

 

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.

 

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