04 Mar 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.

 

The European Medicines Agency said it has begun a rolling review of Sputnik V, the COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The application for EMA approval has been made by the contract manufacturer R-Pharm Germany GmbH.

Rolling review is a way of speeding up the approvals process by assessing data from clinical trials as soon as it is available, rather than waiting until the full data package is complete. The decision to start the rolling review is based on results from laboratory studies and clinical trials indicating Sputnik V triggers an immune response against SARS-CoV-2 coronavirus that could protect against the infection.

Sputnik V is similar to the AstraZeneca COVID-19 vaccine in using adenovirus vectors to deliver the genetic code for the SARS-CoV-2 spike protein by which the virus enters human cells.

However, while AstraZeneca’s vaccine uses the same vector for each dose, Sputnik V uses two different viruses. The aim is to avoid a possible neutralising effect, making for a more effective defence against COVID-19 than using the same vector for both doses.

Sputnik V received validation from the western science establishment in February when the medical journal The Lancet published results of the phase III trial in a peer reviewed paper. The results showed the vaccine is 91% effective.

 

Germany’s health minister Jens Spahn followed France in reversing the decision not to administer AstraZeneca’s COVID-19 vaccine to people over 65 years of age.

Spahn also said the German government will adopt the policy used in the UK, of maximising the public health benefits of limited vaccine supplies, by giving as many people as possible their first dose. Second doses will be administered 12 weeks later, rather than after four weeks, as prescribed on the label.

The change follows publication of three real world studies carried out in the UK, showing a single dose of either AstraZeneca or Pfizer/BioNTech’s COVID-19 vaccine is having a dramatic effect in reducing the number of people over 70 years of age who are admitted to hospital.

The most recent study by researchers at Bristol University published on Wednesday, showed Pfizer/BioNTech was 79.3% effective and AstraZeneca 80.4% effective, in reducing the chances of the most elderly and frail people over the age of 80 being admitted to hospital as a result of serious infection.

Adam Finn, professor of paediatrics at Bristol University and chief investigator on the study, noted the findings are relevant for countries in Europe, which decided not to administer the AstraZeneca vaccine to people over 65, despite the European Medicines Agency approving it for use in this age group.

Finn, who is chair of the World Health Organisation’s European expert technical advisory group on immunisation, which advises on vaccination programmes, told a press briefing, “There are lots of doses of AstraZeneca vaccine available in European countries and they are not being given to people over the age of 65; in some cases over the age of 55, for lack of data.”

“Well here are the data. There are data from Public Health England and Public Health Scotland, and now from us, showing that you can save lives in elderly people by giving them a dose of vaccine,” Finn said.

On Tuesday, France’s regulator Haute Autorité de santé reversed its position that AstraZeneca’s vaccine should only be administered to people under 65, citing the study carried out by Public Health Scotland.

 

Global CO2 emissions declined by around 7% in 2020 compared to 2019 levels, as a result of the lockdown policies implemented around the world to slow the spread of COVID-19.

The data, published in Nature Climate Change, highlight the scale of action and international adherence needed to sustain such reductions post-COVID-19.

Building on their previous work, Corinne Le Quéré and colleagues at the University of East Anglia in the UK report an annual summary of global CO2 emissions for 2020, assessing the impact of COVID-19 restrictions on emissions throughout the year.

They find that global CO2 emissions fell by around 2.6 gigatonnes in 2020, the largest decrease observed to date, to approximately 34 gigatonnes of CO2. This represents a decrease of around 7% over the course of the year compared to 2019 levels.

In contrast, emissions trends in different countries since the adoption of the Paris climate agreement in 2015, show that in high-income countries, emissions had declined by 0.8% per year on average since the Paris agreement, with a further decrease of 9% in 2020 due to COVID-19.

In upper-middle-income countries, growth in emissions had slowed by 0.8% per year since 2015 and declined by 5% in 2020, while in lower income countries, emissions had been increasing by 4.5% per year since 2015, and decreased by 9% in 2020.

The researchers say that decreases in emissions owing to temporary COVID-19 restrictions alone will not result in long-term reductions. In order to sustain decreases in global emissions while supporting economic recovery, large scale deployment of renewable energy and disinvestment in fossil-fuel infrastructure worldwide will be necessary.

 

People over 65 years of age in France will now have access to AstraZeneca’s COVID-19 vaccine, after the regulator Haute Autorité de santé announced a change in policy.

That followed publication of more real world data from the UK vaccination programme, showing this vaccine is equally as effective as that manufactured by Pfizer/BioNTech in preventing serious disease and hospitalisation in people aged over 70.

The research also shows that on top of the protection against symptomatic disease, people vaccinated with one dose of the Pfizer/Biontech product had a lower risk of death. There is not yet enough data to assess the effect of the AstraZeneca vaccine on mortality due to its later rollout.

Combined with the effect against symptomatic disease, this indicates that a single dose of either vaccine is approximately 80% effective at preventing hospitalisation, and a single dose of Pfizer/BioNTech is 85% effective at preventing death from COVID-19.

Taken overall, the data from Public Health England show a single dose of either vaccine was associated with a significant reduction in symptomatic SARS-CoV-2 positive cases in older adults, with even greater protection against severe disease. Both vaccines show similar effects and protection was maintained for the duration of follow-up of six weeks.

Also of note, both vaccines remain effective against the B 1.1.7 variant of concern that was first identified in the UK, and has been reported across Europe and elsewhere.

 

The European Commission has approved €40 million in Italian government grant funding to support biotech ReiThera’s development of its COVID-19 vaccine.

Last November Rome-based ReiThera announced the phase I clinical trial was advancing on schedule and that preliminary results in 45 volunteers, aged 18 – 55 years showed its vaccine was well-tolerated and generated antibodies and T-cell responses at all three doses tested.

The ReiThera vaccine is similar to that made by AstraZeneca, in using a replication defective ape adenovirus as the vector to deliver the genetic code for the spike protein by which COVID-19 enters human cells. In the case of ReiThera, the vector is derived from a gorilla; AstraZeneca’s vaccine uses a chimpanzee-derived vector.

Development of the ReiThera vaccine is a three-pronged, multinational effort, with German biotech Leukocare working on a stable formulation and Univercells in Brussels handling scale-up and manufacturing.

The €40 million grant, approved under the EU’s state aid temporary framework, will fund the phase II/III trial to confirm safety and demonstrate efficacy of the vaccine.

 

Pfizer and BioNTech have begun testing the safety and immunogenicity of a third dose of their COVID-19 vaccine to assess the effect of a booster on immunity against infection by circulating and potential newly emerging SARS-CoV-2 variants.

The study will draw upon participants from the phase I study in the US, who will be offered the opportunity to receive a booster of the current vaccine 6 to 12 months after receiving their initial two doses.

Separately, Pfizer and BioNTech are talking to the US Food and Drug Administration and the European Medicines Agency about a trial of a variant-specific vaccine targeted against the B.1.351 variant, first identified in South Africa. This could position the companies to update the current vaccine quickly if the need arises.

Both FDA and EMA have said they will regulate updated versions of COVID-19 vaccines in the same way as the approval process currently in place for annual updates of flu vaccines.

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and immunity against circulating strains,” said Albert Bourla, CEO of Pfizer. “At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorisation for an updated mRNA vaccine or booster if needed.”

Ugur Sahin, CEO of BioNTech, said, “The flexibility of our proprietary mRNA vaccine platform allows us to technically develop booster vaccines within weeks, if needed. This regulatory pathway is already established for other infectious diseases like influenza. We take these steps in order to ensure a long-term immunity against the virus and its variants.”

The study will evaluate up to 144 phase I participants in two age cohorts, 18-55 and 65-85 years of age. It will include trial participants who received the two doses in the phase I study 6 to 12 months ago in order to assess if a third dose protects against variants.

Participants will be assessed at the time they receive the third dose, then one week and one month after, to see if blood samples neutralise SARS-CoV-2 variants of concern. The participants will continue being followed in the study for up to two years, as originally planned.

 

US biotech Moderna announced it has completed manufacturing of clinical trial material of a vaccine designed to protect against the SARS-CoV-2 variant known as B.1.351, which was first identified in South Africa, and has shipped doses to the US National Institutes of Health (NIH) for a phase I clinical trial, to be led and funded by NIH.

While initial data confirms the approved Moderna COVID-19 vaccine works against B.1.351, the company is evaluating using booster doses of vaccine to increase neutralising immunity against this and other variants of concern.

“We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration,” said Stéphane Bancel, CEO of Moderna. “Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control.”

At the same time, Moderna said it is making new capital investments to increase manufacturing capacity at its own and partner’s facilities. This will increase 2022 manufacturing capacity to approximately 1.4 billion doses. Given the six to nine months needed to add capacity and further time to get regulatory approval, it is estimated it will be 12 months before the additional production is available.

“We are investing in this additional capacity to help us increase production and allow for flexibility in manufacturing potential vaccine boosters to address emerging variants of the virus,” said Bancel.

Moderna is also increasing its base plan for 2021 manufacturing from 600 million doses to 700 million doses, and is exploring other approaches to potentially improve throughput, working to further optimise operations to potentially deliver up to one billion doses in 2021.

To date, the company has shipped approximately 60 million doses globally including approximately 55 million doses shipped to the US government and four million doses from its ex-US supply chain.

 

Scientists from around the world published more than 87,000 papers about the SARS-CoV-2 coronavirus between the start of the COVID-19 pandemic and October 2020, a new analysis shows.

Even given the context of the pandemic, researchers were surprised by the huge number of studies produced on the subject in such a short time.

"It is an astonishing number of publications, it may be unprecedented in the history of science," said Caroline Wagner, associate professor at Ohio State University, who is co-author the research, published in Scientometrics.

The analysis, carried out with Xiaojing Cai at Zhejiang University in China, and Caroline Fry at the University of Hawaii, found 4,875 COVID-19 related articles were published between January and mid-April 2020. That rose to 44,013 by mid-July and 87,515 by the start of October.

Wagner compared the amount of journal papers on the coronavirus to the attention given to nanotechnology, which was one of the hottest areas in science during the 1990s. It took more than 19 years to go from 4,000 to 90,000 scientific articles on that topic. "Coronavirus research reached that level in about five months," she said.

This new study was an update of an earlier one published in July 2020, which found that China and the US led the world in coronavirus research during the early months of the pandemic.

The new study shows China's contributions dropped off significantly after infection rates in the country fell. From Jan. 1 to April 8, Chinese scientists were involved in 47% of all worldwide publications on the coronavirus. That dropped to only 16% from July 13 to October 5.

Similar results were found in other countries when infection levels dropped among their populations.

"At the beginning of the pandemic, governments flooded scientists with funding for COVID research, probably because they wanted to look like they were responding," Wagner said. "It may be that when the threat went down, so did the funding."

In China, the work was also slowed by a government requirement that officials approve all articles related to COVID-19, according to Wagner.

The rate of international collaborations also continued to drop, the study found. Part of the reason was the practical barrier that travel bans made it impossible for researchers to meet.

But there may have also been a political component, Wagner said, particularly in US-China collaborations. The Chinese government's requirement of study review is one factor, but in addition, the US government has been putting Chinese researchers in the US under scrutiny, which may have led some scientists to forgo partnerships.

"We need to figure out a way to restart these collaborations as we move into the post-COVID period," Wagner said. "International cooperation is crucial for the scientific enterprise."

 

COVID-19 vaccination has been linked to a substantial reduction in the risk of being admitted to hospital with COVID-19, according to the first population-level study of a live vaccination programme.

The data cover 1.1 million of 5.4 million people in Scotland  to have received the first dose of either the Pfizer/BioNTech or AstraZeneca vaccines, confirming previous results about vaccine efficacy from clinical trials.

By the fourth week after receiving the initial dose, the Pfizer/BioNTech reduced hospitalisation by 85% and AstraZeneca by 94%, respectively.

The finding is significant because there were not many older people in the AstraZeneca phase III clinical trial. That led Germany to say this vaccine should not be given to the over 65s, but now the data indicate AstraZeneca may be more protective than the Pfizer/BioNTech vaccine in the older age groups.

Among those aged 80 years and over - one of the highest risk groups - vaccination was associated with an 81 per cent reduction in hospital admissions in the fourth week, when the results for both vaccines were combined.

The level of protection seen after a single dose is also an important corroboration of the UK’s controversial policy of maximising population level protection by giving as many first doses to as many people as possible. That is at odds with what it says on the labels of the vaccines, which is that the second dose should be three weeks after the first for Pfizer/BioNTech and four weeks for AstraZeneca   

As part of the EAVE II project, which uses patient data to track the pandemic and the vaccine roll out in real time, researchers from the universities of Edinburgh, Strathclyde, Aberdeen, Glasgow and St Andrew’s and Public Health Scotland analysed a dataset covering the entire Scottish population of 5.4 million.

Data on vaccine effect was gathered between 8 December and 15 February. During this period, 1.14 million vaccines were administered and 21% of the Scottish population had received a first dose.

The Pfizer/BioNTech vaccine had been received by some 650,000 people and 490,000 had had the AstraZeneca vaccine.

Researchers analysed data for every week during this period, including GP records on vaccination, hospital admissions, death registrations and laboratory test results, and compared the outcomes of those who had received their first dose with those who had not.

 

Dynamic modelling of the movements of the proteins in the spike structure via which SARS-CoV-2 enters and infects human cells, has led to the identification of a 'hinge' mechanism, that gives the spike of the virus purchase to hook onto the cell.

The modelling also pinpointed changes in the shape of the virus that then enable it to fuse with the host cell membrane and enter the hooked cell.

The research, led by Warwick University as part of Eutopia, an alliance of six universities funded by the EU Erasmus+ programme, involved simulating movements in the structure of 287 proteins of the Covid-19 virus, in an effort to identify drug targets.

In a paper published in Scientific Reports, the team of physicists and life scientists have made their data, movies and structural information, detailing how the proteins move and how they deform, publicly accessible.

“Knowing how this mechanism works is one way in which you can stop the virus, and in our study we are the first to see the detailed movement of opening,” said lead author, Rudolf Roemer, professor in the department of physics at Warwick University, who did the work while on a sabbatical at CY Cergy-Paris Université. “Now that you know what the range of this movement is, you can figure out what can block it,” he said.

 

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