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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.
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GlaxoSmithKline and its US partner Vir Biotechnology said the independent data monitoring committee has recommended the phase III trial evaluating their antibody drug VIR-7831 in the treatment of mild to moderate COVID-19 in adults at high risk of progressing to a serious infection should be stopped, after an interim analysis found it is highly effective.
The recommendation was based on an analysis of data from 583 patients, which demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831, compared to placebo.
Based on these results, Vir and GSK plan to submit an application for an emergency use authorisation in the US and other countries.
The companies also announced the results of a new study demonstrating VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data.
George Scangos, CEO of Vir said, “The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics.”
VIR-7831 promises to be important in preventing people with COVID-19 who are treated at home progressing to more serious infection. Currently, the drug does have to be administered intravenously, but the two partners are also running a trial to see if it can be administered by a single intramuscular injection.
Pfizer and BioNTech have announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with their COVID-19 vaccine.
These new data build upon and confirm previously released data from the rollout of the vaccine in Israel, demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, hospital admissions, severe and critical cases and deaths.
This latest analysis shows that two weeks after the second dose, protection is even stronger, with vaccine effectiveness of at least 97% in the prevention of symptomatic infections, severe/critical disease and death.
The findings are based on surveillance data collected between 17 January and 6 March 6, when the Pfizer/BioNTech vaccine was the only vaccine available in the country, and when the more transmissible B.1.1.7 variant of SARS-CoV-2 first detected in the UK, was the dominant variant.
The analysis also found the vaccine is 94% effective against asymptomatic SARS-CoV-2 infections. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose.
The findings, which suggest the vaccine may also provide protection against asymptomatic SARS-CoV-2 infections are “particularly meaningful as we look to disrupt the spread of the virus around the globe,” said Luis Jodar, chief medical officer of Pfizer Vaccines.
A new academic spin-out, Rokote Laboratories is preparing the ground for clinical trials of a nasally administered COVID-19 vaccine, after the spray performed well in animal studies.
The vaccine, based on research carried out at the University of Helsinki and the University of Eastern Finland, uses a non-replicating adenoviral vector to deliver the genetic code for a SARS-CoV-2 protein, causing nasopharyngeal cells to generate the protein and spark an immune response.
The researchers chose nasal delivery because the virus is also naturally transmitted through the airways. It is expected nasal administration will induce a wider immune response than the intramuscular injections used for existing COVID-19 vaccines.
The vaccine is also designed to be effective against emerging variants of SARS-CoV-2. “Our vaccine already takes into account the most important variants, that is, the South African, Brazilian and the UK one. There will certainly be a demand for this type of vaccine," said Kalle Saksela, professor of virology at the University of Helsinki.
There is manufacturing in place to produce the vaccine in Kuopio and Rokote will carry out the first clinical trials in Finland. The company is now seeking funding for the further development of the vaccine.
Abivax said it was stopping the phase IIb/III clinical trial of its combined antiviral/anti-inflammatory drug, ABX-464, in high-risk COVID-19 patients, after the independent data safety and monitoring board said there was a lack of efficacy.
The multinational trial, which had recruited 500 high-risk COVID-19 patients out of a planned 1,034, was declared a ‘National Research Priority’ by the French government in December 2020.
The study was a randomised, double-blind and placebo-controlled design to test whether ABX-464 could prevent the development of severe COVID-19 disease in the participants. The recommendation to stop the trial was based on a planned, interim analysis evaluating data from 305 patients who completed the study. The comparison of the data generated in the patient group treated with ABX-464, versus the placebo group who received standard of care, did not show a difference in the rate of severe disease.
Jorge Kalil, head of clinical immunology and allergy at the University Hospital Centre in São Paulo and national coordinator of the study in Brazil, said, “As an immunologist, I am puzzled by the outcome of the interim analysis, as ABX-464 addresses both the viral and inflammatory aspects of the disease. However, we recognise that COVID-19 is a novel, hyper-acute and complex disease that involves various viral and inflammatory pathways, plus the coagulation system, which are still not fully understood.”
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.
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