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.

new piece of research shows that during the pandemic scientists have made increasing the use of preprints to publish their research and these papers are being read more frequently.

This has prompted a cultural shift in how preprints are used and viewed, with the media and the public taking far more interest, according to Jonathon Alexis Coates of Queen Mary University of London, a co author of the paper.

Preprints are free to read, often updated, and most importantly, enable researchers to share their research when it is complete, rather than having to submit to a journal and await acceptance – or rejection – and peer review.

Apart from open access, a benefit is that the process of science is speeding up. Preprints are typically posted within two days of being submitted to a server, in contrast to the months or years that it can take for research to go through peer review, Coates says.

Although many journal publishers have prioritised COVID-19 research and taken down paywalls, on average it still takes 34 times longer for a paper to be published in a journal rather than posting it on a preprint server, which takes 24 - 48 hours).

According to the research, during the first ten months of the pandemic, more than 25% of COVID-19 publications, or 30,260 papers, first appeared as preprints. (That includes this particular paper, which has now appeared in a peer review journal, after earlier being published as a preprint).

COVID-19 preprints were viewed 18.2 times and downloaded 27.1 times more than non-COVID preprints posted during the same ten-months.

COVID-19 preprints are also being used to directly influence policymaking decisions. The World Health Organisation and the European Centre for Disease Control have cited preprints in policy documents during the pandemic. Coates says that in similar policy documents from before COVID-19, preprints don’t appear to have been widely referred to before.

COVID-19 broke the mould of the 9 – 5 day in the office overnight. There have since been many analyses of people’s experiences when they were forced to work from home during lockdown, and now researchers in Denmark have drawn on this to devise a tool that can be used to systematically identify pros and cons when drawing up home working policies.

The researchers, at DTU Management in Lyngby, Denmark, identified six areas they say managers should focus on when developing strategies for remote work in future.

“We’ve examined the pros and cons of working from home among managers and employees in knowledge jobs in eight European countries,” said Christine Ipsen, associate professor at DTU (Technical University of Denmark), who is one of the researchers behind the study.

The tool is based on answers to questionnaires in the eight European countries, completed by people who worked from home during the lockdown from mid-March to mid-May 2020.

“Most people felt that working from home provided benefits in terms of better work/life balance, increased efficiency, and more control over their own work. These three advantages outweighed the three main disadvantages: the inevitable shortcomings of the home office, the greater uncertainty when you don’t meet physically with your boss and colleagues, and finally the reduced access to necessary work tools that are normally available in the office,” Ipsen said.

But it’s not a given that everyone feels positive about working from home. “By analysing employees’ experiences based on the six factors we identified, management can get an overview of what to keep in mind, and when to take action in relation to different employee groups,” said Ipsen.

The researchers found that young people aged 18 to 30 scored higher when it came to work/life balance than employees over the age of 31. On the other hand, young people had more problems with uncertainty about the work compared to older generations, who perceived inadequate tools as a bigger problem.

“It’s about minimising the disadvantages, because the trend we’re seeing shows that people will work more from home in the future, even when [COVID-19] no longer dominates society,” Ipsen said.

Experiences of remote work may change in the future, Ipsen noted. “More studies are needed to look at the six factors over time and in more industries,” she said.

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) kicked off a new initiative aimed at strengthening monitoring of the safety, effectiveness and impact of COVID-19 vaccines.

With the ongoing authorisation and rollout of several COVID-19 vaccines in the EU, jointly coordinated, large-scale, EU-wide effectiveness and safety studies are an essential tool to see how novel vaccines perform in real life, according to the two agencies. These studies will generate evidence to support continuous assessment of the benefits and risks of the vaccines and inform decision making on their use in national or regional vaccination strategies.

The move comes after EMA was criticised by member states for not providing explicit advice on the use of AstraZeneca’s and Johnson & Johnson’s vaccines, following its review of rare cases of unusual blood clots. EMA concluded the clots are a rare side effect of the vaccines, but said it was up to national governments to decide how to shape vaccines rollout in response to this finding.

EMA and ECDC will jointly coordinate and oversee a number of observational studies funded from the EU budget and conducted in several European countries. EMA will lead on monitoring safety and ECDC on the effectiveness of vaccines.

This work will be supported by a joint advisory board (JAB) to the two agencies.

“Observational research is an important pillar in the post-marketing surveillance of COVID-19 vaccines and increased EU level collaboration is needed so that member states can join forces and organise large studies that meet the needs of both medicines regulators and national institutes for public health and vaccination,” said Emer Cooke, EMA’s executive director.

“This new model of collaboration brings medicine regulators and public health authorities closer together and establishes processes towards a more permanent, sustainable collaboration platform for monitoring vaccine safety and effectiveness,” said Andrea Ammon, ECDC director.

Pharmaceuticals ingredient manufacturer Evonik said it has delivered the first lipids from its facility in Hanau, Germany, to BioNTech, for the manufacture of the Pfizer/BioNTech COVID-19 vaccine.

The delivery is months earlier than planned, with specialists at the Hanau site setting up the lipid production in just eight weeks. Initially, delivery was scheduled to start in the middle of the year.

"Setting up production at this speed is a great achievement," said Christian Kullmann, chair of Evonik. "Increasing lipid production in Germany will also allow us to further accelerate the manufacturing of larger quantities of the vaccine."

Initial manufacture of the Pfizer/BioNTech vaccine at Pfizer’s plant in Belgium relied on imports of lipids from a manufacturer in the UK, and the head of the EU’s vaccines taskforce Thierry Breton, competition commissioner, has been working to increase EU autonomy and end-to-end control of vaccines supply chains.

As part of its strategic partnership with BioNTech, Evonik produces two different lipids for the Pfizer-BioNTech COVID-19 vaccine. Together with other lipids, they encapsulate to form a lipid nanoparticle, which works as a protective shell around the messenger RNA that carries the genetic code for the spike protein of the virus. Once injected, the mRNA is released to allow the vaccine to take effect.

"This is a complex production process that only a few in the world master," said Thomas Riermeier, head of Evonik's health care business.

The European Medicines Agency (EMA) has concluded there is a possible link between Johnson & Johnson’s single dose COVID-19 vaccine and eight cases of unusual blood clots seen in people who received the vaccine in the US, but said the benefits of vaccination outweigh the risks.

A warning about the rare clots will be added to the label and listed as a very rare side effect of the vaccine.

EMA looked at all the currently available evidence, which consisted of eight reports of the clots occurring among over seven million people who had received Johnson & Johnson’s vaccine in the US, as of 13 April.

Following the reports, use of the vaccine was put on hold in the US and Johnson & Johnson said it would be delaying rollout in Europe, telling member state governments to put supplies into storage.

Following a meeting on 14 April the US Food and Drug Administration and the Centers for Disease Control, jointly decided they needed more time to deliberate and extended the hold. They are expected to announce a decision on Friday (23 April).

EMA said it was able to conclude its review sooner because of its experience in looking at similar rare clots that have been seen in people who received the AstraZeneca vaccine.

It is possible to treat the rare clots, EMA said. Now the warning is on the label and healthcare providers and the public have been alerted to the symptoms, it will be up to member states to decide on the rollout of the Johnson & Johnson vaccine. That decision should be based on the level of infection, the number of people in hospital and intensive care, and the availability of other vaccines, EMA said.

“EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual member states,” the agency said.

The UK government has set up a pandemic preparedness partnership to advise the G7 group of nations on how to harness international collaboration to intensify research and development, modernise clinical trials and improve vaccines manufacturing and supply chains.

The partnership, meeting formally for the first time today, will be backed by £16 million in additional funding from the UK government to support the work of the Coalition for Epidemic Preparedness Innovations (CEPI) on global vaccine supply.

The public private partnership, chaired by UK government chief scientific adviser Patrick Vallance, brings together industry, international organisations and leading experts. It will provide recommendations for delivering on targets to more quickly develop vaccines, therapeutics and diagnostics, through greater global cooperation on research and development, manufacturing, clinical trials and data sharing.

The partnership will report to leaders at the G7 summit, to be held in Cornwall in June, which the UK is hosting as current president of the G7.

The £16 million investment in CEPI will fund global vaccine manufacturing capacity and R&D to rapidly respond to the threat of new variants of SARS-Cov-2, supporting the development of variant-specific vaccines.

The aim is to have millions of doses of a vaccine available for emergency use by 100 days after a variant of concern is identified.

“COVID-19 has shown us that it’s possible to develop and deploy high quality vaccines much faster than previously imagined,” Vallance said. “We have brought together the pandemic preparedness partnership to see whether this can be accelerated even further and applied to the development of medicines and diagnostic tests.

SARS-CoV-2, the virus that causes COVID-19, can mutate in mink in a way that reduces immune control by antibodies, according to new research carried out at the German Primate Centre at the Leibniz Institute for Primate Research in Göttingen.

The research shows that an antibody used in an approved COVID-19 therapy is unable to effectively inhibit SARS-CoV-2 harbouring a spike mutation acquired in mink and that the mutation also reduces the effect of neutralising antibodies produced in people following infection with SARS-CoV-2.

It has been known for about a year that mink can become infected with SARS-CoV-2 and that the virus had been transmitted from humans to farmed mink and has mutated in infected animals.

Mutations were acquired in the spike protein, via which the virus enters human cells, with these SARS-CoV-2 variants then being transmitted back to humans, raising concerns that mink could be a continuing source of infection of humans.

As a result, in June 2020 the Danish government ordered a mass cull of 15 million farmed mink to prevent the transmission of new viral variants to humans. Other European governments have also ordered control measures.

Researchers at the German Primate Centre looked at a number of mutations found in the spike protein in farmed mink, including Y453F. “Our results show that one of two antibodies from an antibody cocktail used for COVID-19 therapy no longer efficiently inhibits the viral variant with the Y453F mutation,” said researcher Markus Hoffman.

“Furthermore, our study demonstrates that the Y453F mutation reduces inhibition of the virus by antibodies produced by COVID-19 patients. This means that people who were infected with SARS-CoV-2 may have reduced protection against mink variants of the virus", Hoffman said.

Researchers at Oxford University have reported the risk of rare blood clots (cerebral venous thrombosis, CVT) following COVID-19 infection is around 100 times greater than normal and several times higher than the risk after vaccination, or following a bout of influenza.

Paul Harrison, professor of psychiatry at Oxford University, who led the research, said, “There are concerns about possible associations between vaccines and CVT, causing governments and regulators to restrict the use of certain vaccines. Yet, one key question remained unknown: ‘What is the risk of CVT following a diagnosis of COVID-19?’”

“We’ve reached two important conclusions. Firstly, COVID-19 markedly increases the risk of CVT, adding to the list of blood clotting problems this infection causes. Secondly, the COVID-19 risk is higher than seen with the current vaccines, even for those under 30; something that should be taken into account when considering the balances between risks and benefits for vaccination,” Harrison said.

The researchers counted CVT cases diagnosed in the two weeks following diagnosis of COVID-19, or after the first dose of a COVID-19 vaccine. They then compared these to the incidence of CVT following influenza, and to the background level in the general population.

They found CVT is more common after COVID-19 than in any of the comparison groups, and that 30% of these cases occurred in people under 30 years of age. The risk compared to current COVID-19 vaccines is between 8-10 times higher, and compared to the normal background level, approximately 100 times higher.

  • In the study of over 500,000 COVID-19 patients, CVT occurred in 39 in one million patients.
  • In over 480,000 people who received a COVID-19 mRNA vaccine (Pfizer or Moderna), CVT occurred in 4 in one million.
  • CVT has been reported to occur in about 5 in one million people after first dose of the AstraZeneca COVID-19 vaccine.
  • Compared to the mRNA vaccines, the risk of a CVT from COVID-19 is about 10 times greater.
  • Compared to the AstraZeneca, the risk of a CVT from COVID-19 is about 8 times greater.

However, all comparisons must be interpreted cautiously since data are still accruing.

Graphic Covid Blog

Negotiations have begun on a third advance purchase agreement for 1.8 billion doses of the Pfizer/BioNTech COVID-19 vaccine, with the European Commission stipulating that manufacturing of the product and all the components that go into it must be based in the EU.

The doses will be delivered from 2021 to 2023. Commission president Ursula von der Leyen announced the negotiations as the EU reached the milestone of administering 100 million vaccinations. Of these, more than a quarter were second doses.

To date, member states have received a total of 126 million doses of vaccine, and after a stuttering start, vaccination rates are picking up. But another delay is looming, with rollout of Johnson & Johnson’s vaccine now on hold pending investigation into unusual blood clots in six people who received the product in the US.

This comes on top of holds in a number of member states on using AstraZeneca’s vaccine, also put in place as a result of concerns about of blood clots that the European Medicines Agency said is a rare side effect.  

“As we can see with the announcement by Johnson & Johnson yesterday, there are still many factors that can disrupt the planned delivery schedule of vaccines,” von der Leyen said.

To try and fill this gap, the Commission has also agreed with Pfizer/BioNTech that 50 million doses that were due in the third quarter of 2021 will now be delivered in Q2. This will bring the total doses delivered by Pfizer to 250 million doses in the second quarter. These will be distributed pro-rata to the population, among all the member states.

 

 

The US Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have called a temporary halt to the use of Johnson & Johnson’s COVID-19 vaccine while they conduct a review, following six reports of rare blood clots.

CDC said it will convene a meeting of its Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance, with FDA subsequently reviewing that analysis.

As of April 12, more than 6.8 million doses of the single shot Johnson & Johnson vaccine have been administered in the US.

The six blood clots are similar to those seen with AstraZeneca’s vaccine in Europe. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the joint CDC/FDA statement said.

 

 

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