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

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.

The Danish government ordered up to 15 million mink to be culled after evidence that mutated forms of the SARS-CoV-2 virus have spread from farmed animals to humans.

The variants coming from mink have been shown to have mutations affecting the spike protein through which the virus infects humans. This is the protein on SARS-CoV-2 that is targeted by most of the COVID-19 vaccines currently in development, and Danish prime minister Mette Frederiksen said there are concerns it could undermine the effectiveness of vaccines if it spreads further in humans.

In a risk assessment, the Danish infectious diseases control agency, Statens Serum Institut, found that the mink-derived virus exhibited decreased susceptibility to neutralising antibodies from the blood of several people who had recovered from COVID-19 infection. In addition, a large virus reservoir in mink increases the chances that further mutations will arise, and that there will be more transmission of these variants to humans.

Since the beginning of August 2020, 168 mink farms have been infected in North Jutland - all with the SARS-CoV-2 mink variant. In parallel, there is an increasing incidence of the mink variant among citizens in the region, with approximately half of infections due to the SARS-CoV-2 mink variant.

Denmark is the biggest producer of mink fur in the world, selling around 17 million pelts per annum.

The European region has seen a 22 per cent increase in new cases of COVID-19 and a 43 per cent increase in deaths in the past seven days compared with the previous week, according to the latest data from the World Health Organisation (WHO).

At a global level, Europe reported half of new cases, with over 1.7 million positive tests. There were 17,000 deaths.

France, Italy, and the UK reported the highest numbers of new cases, although Andorra, the Czech Republic and Belgium reported the highest per population incidence. France accounted for the third highest number of new cases globally, with over 275,000 positive tests reported in the past week (4,200 cases per million population). That is an increase of 27 per cent from the previous week.

New cases in Belgium fell by 21 per cent from last week to 82,500, while those in Italy rose by 72 per cent from last week to 175,000 new cases.

Despite the fall seen in Belgium, it still has one of the world’s highest incidences of the infection, with 7,000 new cases per million population. Italy’s incidence is lower at 2,800 cases per million.

In Switzerland, the number of new cases grew considerably in October, rising from fewer than 2,500 per week reported from mid-April through to the end of September - and fewer than a hundred cases reported in some weeks - to 50,000 new cases in the past week. Switzerland has the fifth-highest incidence of new cases in the region, at 5,800 cases per million population.

While weekly testing rates have increased in Switzerland, test positivity rates have also increased from 15 per cent to 22.5 per cent, as of 25 October.

In the past week, over 3.3 million new cases of COVID-19 infection have been reported globally. As of 1 November, nearly 46 million cases and 1.2 million deaths have been reported to WHO.

COVID-19 has created a sense of uncertainty about research funding, according to a survey of more than 25,000 scientists in 152 countries, with 47 per cent of respondents saying less funding will be available in the future as a result of COVID-19, signalling a potentially lasting effect.

"The impact of COVID-19 is manifesting itself across the funding landscape. While it is critical that collectively, we do everything we can right now to combat the virus, we must also recognise that diverting or the 'covidisation' of funding away from other fields is not a sustainable solution,” said Kamila Markram, CEO and co-founder of the open access academic publisher Frontiers, which carried out the survey. “The environment, for example, is an area we simply cannot afford to neglect.”

The survey found researchers are divided over their perceptions of government responses to the pandemic.  Those that showed a significantly higher level of dissatisfaction with policy makers' use of scientific advice during the pandemic include the US, Brazil, Chile and the UK, while those in New Zealand, China, and Greece were the most satisfied.

"While we do not know what advice was given and if it was used, this data suggests more comfort in those countries that are coping well, those who took early lockdown decisions, have had similar previous experience, for example with SARS, and who recognised science as key to pandemic management decision making,” said Peter Gluckman, chair of the International Network for Government Science Advice.

The survey to assess the initial impact of the coronavirus pandemic on scientists was conducted by Frontiers between May and June.

“Scientists are under extraordinary pressure to deliver answers and a lack of precedent and preparation, combined with severe political and social pressures, has made this an incredibly challenging time for them,” said Markram. “Along with the disruption faced by most of the world's population - lockdown, remote working, isolation and anxiety - many researchers have felt an added pressure to understand, cure and mitigate the virus."

The survey shows scientific research has been able to continue for the large part, despite the disruption of COVID-19. When asked what they had been working on during the pandemic, 74 per cent of respondents said writing papers, 57 per cent continued with their research, and 42 per cent did virtual teaching.

The head of the WHO Tedros Ghebreyesus is in quarantine after coming into contact with someone with a confirmed COVID-19 infection. 

“I have been identified as a contact of someone who has tested positive for COVID-19. I am well and without symptoms, but will self-quarantine in the coming days, in line with WHO protocols,” Ghebreyesus said in his media briefing on Monday.  

One of the drugs identified by the EU-funded supercomputing consortium Exscalate4CoV as having potential to treat COVID-19 infections, has now received approval for a 450 patient trial in Italy.

Raloxifene, approved for the treatment of the bone thinning disorder osteoporosis, was found to have antiviral properties. It will be tested in patients who have mild COVID-19 symptoms.

Exscalate4CoV screened 400,000 molecules in silico, selecting 7,000 for testing in the laboratory. The work was funded by a €3 million EU Horizon 2020 grant. A patent on the use of raloxifene for the treatment of people infected by COVID-19 was filed on 6 May 2020 by the Italian pharma company Dompé farmaceutici, the Fraunhofer Institute and Leuven University. They say the aim is to promote universal access to therapies that may be developed by Exscalate4CoV.

Sanofi and GlaxoSmithKline have committed to make 200 million doses of their COVID-19 vaccine available through the COVAX vaccines distribution mechanism set up by the World Health Organisation, if the vaccine is approved.

COVAX was set up to ensure rapid, fair and equitable access to COVID-19 vaccines. As of mid-October, 92 richer countries, including the EU27, have signed up to pay for vaccines procured through COVAX, for their own populations, and to make donations to 92 lower income countries. The mechanism is being overseen and co-led by GAVI, the global vaccines alliance, and CEPI, the Coalition for Epidemic Preparedness Innovations.

COVAX aims to procure, equitably allocate and deliver two billion doses of safe and effective COVID-19 vaccines by the end of 2021. Seth Berkley, GAVI CEO said, “Gavi is seeking to secure doses of the most promising vaccine candidates – so that the 184 participants involved in the COVAX Facility can make sure their most at-risk groups, such as healthcare workers, have rapid access to doses of a safe and effective vaccine. That is the world’s best chance to end the acute stage of this pandemic, and we encourage other vaccine manufacturers to work with us towards that shared global goal.”

As of 6 October, COVAX had received pledges of  $1.7 billion to procure COVID-19 vaccines for donating to poorer countries.

The Institute for Public Policy Research (IPPR) published its Research at Risk report, warning the hit to charity fundraising from COVID-19 could mean up to £7.8 billion less for medical research in the UK between now and 2027.

Medical research charities that rely on events and high street shops for much of their funding have seen a 40 per cent fall in income as a result of the pandemic.

IPPR modelling predicts that lost charity income could mean, in a worst-case scenario, that medical research charities invest £4.1 billion less in health R&D between now and 2027. That is predicted to have a knock-on effect on private investment in collaborative research, which could fall by as much as £1.3 billion.

An additional fall in private investment, due to adverse economic conditions, of £2.5 billion, puts £7.8 billion of medical research investment is at risk. IPPR says the government should introduce a new, three year life sciences charity fund, equal to the shortfall in medical charity income caused by Covid-19 and lasting for three years. Charities should be free to use this fund as needed to maintain their R&D portfolios.

This matches an earlier call by Aisling Burnand chief executive of the Association of Medical Research Charities, a body representing160 charities that between them put £1.9 billion into R&D in 2019. “Looking at the years ahead, not only will there be a drastic shortfall in charity funded research, but the knock on impact on levels of private R&D investment will be sizable,” Burnand said. “The IPPR Research at Risk report gives a strong economic rationale for the proposed Life Sciences Charity Partnership Fund.”