13 Apr 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 Commission is to set out a common EU strategy on COVID-19 therapeutics in mid-April, to parallel the approach it used to promote vaccines research and procurement.

The move was announced as part of a common path to safe and sustained lifting of COVID-19 lockdown measures across the EU, published on Wednesday.

Currently, a number of instruments including joint procurement, are being used to secure access for member states to the limited number of drugs that are available to treat COVID-19 infections. But the Commission says, “More and faster action is needed.” The aim of the strategy will be to speed up research and manufacturing.

There will also be more flexibility around drug regulation to enable rapid supply at large scale during the pandemic.

 

 

 

 

 

 

As part of its support for member states in the fight against COVID-19, the European Commission is purchasing 200 ultraviolet light disinfecting robots, for delivery to hospitals around Europe during 2021.

The robots can disinfect a standard size patient room in as little as 10 minutes and can clean more than 18 rooms on one charge. This will help ensure a sterile environment in hospitals, without exposing staff to unnecessary risk.

The €12 million programme got underway following a study by researchers from the European Society of Clinical Microbiology and Infectious Diseases looking at the feasibility of deploying the robots, which was published last month.

This concluded disinfection robots have already been shown to be a promising tool for surface decontamination in hospitals, with even greater potential to come. Adjustments to both hospitals and devices are needed to allow the free movement of robots. More research is required to define effective wavelengths and exposure times, to allow sufficient energy to be applied to each surface, as a function of which pathogen is to be inactivated.

 

 

 

 

 

The European Medicines Agency’s safety committee is meeting on Tuesday to review data on AstraZeneca’s COVID-19 vaccine after several member states suspended its use following reports of blood clots in people who received the vaccine.

EMA said it is working with the company, experts in blood disorders and other health authorities. These include the UK Medicines and Healthcare products Agency, cut out of EMA as a result of Brexit, but now sitting on a large safety database, with around 11 million doses of the vaccine administered in the UK to date, and few reports of serious adverse events.

Meanwhile, in an attempt to fill the gap, Pfizer and BioNTech have agreed with the European Commission to accelerate delivery of ten million doses of their vaccine between April and June.

Commission President Ursula von der Leyen said, “These accelerated ten million doses will bring the total doses of Pfizer/BioNTech in quarter two up to over 200 million.” This gives member states room to manoeuvre, she said.

These doses will be drawn forward from the 100 million doses that were due to be delivered in Q3 and Q4 of 2021. 

EMA said its experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the AstraZeneca vaccine might have contributed, or if blood clots could have been due to other causes. After reviewing the data today, EMA has called a meeting on Thursday to decide on any further action.

While it investigates, EMA said it currently remains of the view that, “The benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.”

 

 

 

 

More than 300 COVID-19 machine learning models were described in papers published in 2020 but none is suitable for detecting or diagnosing COVID-19 from standard medical imaging, due to biases, methodological flaws, lack of reproducibility, and inappropriate datasets, according to a systematic review.

Researchers led by Cambridge University reviewed 2,212 studies published between 1 January and 3 October 2020, describing machine learning models that claimed to be able to diagnose or predict the severity of COVID-19 from chest Xrays or computed tomography images.

After quality screening, 62 studies were included in the systematic review. None of the 62 models was of potential clinical use, according to results reported in Nature Machine Intelligence.

“Any machine learning algorithm is only as good as the data it's trained on,” said first author Michael Roberts from the department of applied mathematics at Cambridge University. "Especially for a brand-new disease like COVID-19, it's vital that the training data [are] as diverse as possible because, as we've seen throughout this pandemic, there are many different factors that affect what the disease looks like and how it behaves."

 

 

 

 

 

 

The European Medicines Agency has recommended approval of Johnson & Johnson’s single dose COVID-19 vaccine.

“With this latest positive opinion, authorities across the EU will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director. “This is the first vaccine which can be used as a single dose.”

Results from a clinical trial involving 44,000 people in the US, South Africa and Latin American countries found there was a 67% reduction in the number of symptomatic COVID-19 cases after two weeks in people who received the vaccine (116 cases out of 19,630 people), compared with people given placebo (348 of 19,691 people).

The vaccine is already approved in the US.

 

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.

 

 

 

 

 
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