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

02 Dec 2021 | Live Blog
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 and here.

The EU and member states should implement a joint strategy to limit the entry of the Omicron variant into the EU, with daily reviews of essential travel restrictions, and be ready to impose all necessary controls, the Commission said in a statement calling for a coordinated approach to dealing with the resurgence of COVID-19.

There is a rapidly rising number of infections across Europe caused by the Delta variant of SARS-CoV-2, which is putting renewed pressure on hospitals. The new potential threat from the Omicron variant is adding to these concerns, the Commission said.

“Over the last couple of weeks, many of us have witnessed it first hand: COVID 19 has resurged,” said Ursula von der Leyen, president of the European Commission. On top of this, the arrival of the “presumably highly contagious” Omicron variant calls for “our utmost attention,” she said.

Member states need to step up vaccination and investment in treatments and improve monitoring and prevention.

Stella Kyriakides, commissioner for health said the high transmissibility of the Delta variant, the high number of people who are not vaccinated, and the easing of control measures such as social distancing and mask wearing “will bring us a challenging winter.”

“The emergence of the Omicron variant only adds to the urgent need to vaccinate and to boost our immunity in order to break transmission chains,” Kyriakides said.

The Commission said it will step up efforts to manufacture, authorise and jointly procure COVID-19 therapeutics.

“The COVID-19 pandemic has brought into focus how open science practices such as open access to scientific publications, the sharing of scientific data and collaboration beyond the scientific community can speed up research and strengthen the links between science policy and society,” said Audrey Azoulay, UNESCO director general, unveiling the first global definition of open science.

The framework, which has been adopted by 193 countries, will make science more transparent and more accessible, equitable and inclusive, allowing scientists and engineers use open licenses to share their publications and data, software and even hardware more widely.

That will enhance international scientific cooperation, Azoulay said. “The UNESCO Recommendation on Open Science will drive the wider adoption of open practices, encourage greater endorsement of open science and ensure that research findings are beneficial to all.”

While currently some 70% of scientific publications are locked behind paywalls, over the past two years, this proportion has dropped to about 30% for publications on COVID-19, showing science can be more open.

Before the UNESCO framework, there was no universal definition of open science, with standards set only at regional, national or institutional levels. In adopting the framework, the 193 countries have agreed to abide by common standards and adopted a common roadmap. The signatories will report back every four years on their progress.

The European Centre for Disease Control said that as of 1 December 2021, 15 additional cases of the Omicron variant of concern have been confirmed, bringing the total to 59 confirmed cases.

The cases have been reported across Europe, in  Austria (3), Belgium (2), Czechia (1), Denmark (4), France (1, in Réunion), Germany (9), Italy (4), the Netherlands (16), Portugal (14), Spain (2), and Sweden (3).

A number of probable cases have also been reported from across the region, but are still under investigation. All cases for which there is available information on severity were either asymptomatic or mild and it remains the case that to date, there have been no severe infections and no deaths reported.

The UK Medicines and Healthcare products Regulatory Agency has approved the use of Xevudy, an antibody developed by GlaxoSmithKline, for people with mild to moderate COVID-19, who are at high risk of developing severe disease.

This is the second monoclonal antibody therapeutic to be approved in the UK, following Ronapreve.

The European Medicines Agency began its review of Xevudy on 18 November, when it said, “it could deliver an opinion within two months.” The agency previously approved Ronapreve, developed by Roche, along with another monoclonal antibody Regkirona, developed by the South Korean biotech Celltrion, for COVID-19.

Xevudy works by binding to the spike protein on the outside of the COVID-19 virus, preventing the virus from attaching to and entering human cells, so that it cannot replicate in the body.

In a clinical trial, a single dose of the intravenously administered antibody was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection. Risk factors include diabetes, heart disease and age over 60. The drug is most effective when taken during the early stages of infection and it should be used as soon as possible, and within five days of symptom onset.

MHRA said it is too early to know whether the Omicron variant has any impact on Xevudy’s effectiveness, but it will work with GSK to establish this.

The UK Medicines and Healthcare products Regulatory Agency has approved the use of Xevudy, an antibody developed by GlaxoSmithKline, for people with mild to moderate COVID-19, who are at high risk of developing severe disease.

This is the second monoclonal antibody therapeutic to be approved in the UK, following Ronapreve.

The European Medicines Agency began its review of Xevudy on 18 November, when it said, “it could deliver an opinion within two months.” The agency previously approved Ronapreve, developed by Roche, along with another monoclonal antibody Regkirona, developed by the South Korean biotech Celltrion, for COVID-19.

Xevudy works by binding to the spike protein on the outside of the COVID-19 virus, preventing the virus from attaching to and entering human cells, so that it cannot replicate in the body.

In a clinical trial, a single dose of the intravenously administered antibody was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection. Risk factors include diabetes, heart disease and age over 60. The drug is most effective when taken during the early stages of infection and it should be used as soon as possible, and within five days of symptom onset.

MHRA said it is too early to know whether the Omicron variant has any impact on Xevudy’s effectiveness, but it will work with GSK to establish this.

As of 29 November 2021, 33 confirmed cases of the Omicron variant of concern have been reported in Austria, Belgium, Czechia, Denmark, Germany, Italy, Netherlands and Portugal, according to the European Centre for Disease Control and Surveillance (ECDC).

A number of probable cases have also been reported that are still under investigation. All confirmed cases have a history of travel to African countries, with some having taken connecting flights at airports between Africa and Europe.

Separately, Scotland’s health minister Humza Yousaf said six cases reported in Scotland were not all related to travel, indicating there may be some community transmission.

ECDC said for those cases for which there is information available severity was either asymptomatic or mild. No severe cases and no deaths have been reported among Omicron cases so far.

In collaboration with academic groups in South Africa and around the world, Johnson & Johnson is now evaluating the effectiveness of its COVID-19 vaccine against the new and rapidly spreading Omicron variant, testing blood serum from participants in completed and ongoing booster studies to look for neutralising activity against the variant.

At the same time, the company said it is working on an Omicron-specific variant vaccine, which it will advance as needed.

Omicron highlights the importance of continued surveillance, testing and vaccination to prevent hospitalisation and deaths from COVID-19, said Mathai Mammen, global head of Janssen Research & Development at Johnson & Johnson. “We will not be complacent. Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real world effectiveness studies being conducted with the Johnson & Johnson COVID-19 vaccine, we will work together to generate new data on Omicron.”

“In parallel, we have begun work to design and develop a new vaccine against Omicron and will rapidly progress it into clinical studies if needed,” Mammen said.

There is considerable uncertainty related to the transmissibility, vaccine effectiveness, risk for reinfections and other properties of the Omicron variant of SARS-CoV-2, the European Centre for Disease Control said in its assessment of the threat of the new variant.

However, given its immune escape potential and potentially increased transmissibility advantage compared to Delta, “We assess the probability of further introduction and community spread in [Europe] as ‘high’,” CDC said.

With the number of COVID-19 infections caused by the Delta variant already on the rise in Europe before the emergence of Omicron was announced by South Africa’s Ministry of Health on Friday 26 November, the impact of the introduction and possible further spread of Omicron could be ‘very high’, ECDC added.

Based on the mutation profile of Omicron, partial immune escape is likely, and genomic surveillance remains of utmost importance for early detection of the presence of this variant, to enable the following of epidemiological trends and guide containment measures.

Following on from the announcement of the emergence of the new variant, its naming and designation by the World Health Organization as a variant of concern, cases have been reported from across Europe and in Canada.

Moderna said it is testing three existing COVID-19 vaccine booster candidates against the Omicron variant and also developing a new variant-specific vaccine candidate against the SARS-CoV-2 variant of concern that was first identified in South Africa.

Omicron includes mutations seen in the Delta variant that are believed to increase transmissibility, and mutations seen in the Beta and Delta variants that are believed to promote immune escape, making vaccines less effective. The combination of mutations represents a significant potential risk of the waning of natural and vaccine-induced immunity and a booster dose of an authorised vaccine represents the only currently available strategy for boosting waning immunity.

Moderna is working to test the ability of the current vaccine dose to neutralise the Omicron variant and data is expected in the coming weeks. The company has also tested a higher dose booster in healthy adults and has completed dosing of 306 participants in a safety and immunogenicity study of this high dose.

In addition, Moderna is studying two multi-valent booster candidates in the clinic, that are designed to anticipate mutations such as those that have emerged in the Omicron variant. The first candidate includes several mutations present in Omicron that are also present in the Beta variant, while the second includes many of the mutations present in Omicron that also occur in both the Beta and Delta variants.

Now Moderna will rapidly advance an Omicron-specific booster candidate and says it has demonstrated the ability to advance new candidates to clinical testing in 60-90 days.

“The mutations in the Omicron variant are concerning and for several days we have been moving as fast as possible to execute our strategy to address this variant,” said Stéphane Bancel, CEO of Moderna. “We have three lines of defence that we are advancing in parallel: we have already evaluated a higher dose booster of mRNA-1273; second, we are already studying two multi-valent booster candidates in the clinic that were designed to anticipate mutations such as those that have emerged in the Omicron variant and data is expected in the coming weeks; and third, we are rapidly advancing a Omicron-specific booster candidate,” he said.

The protection two doses of the Pfizer/BioNTech vaccine provide from COVID-19 infection wanes with time, suggesting a third booster dose might be necessary, according to an Israeli study published in the British Medical Journal.

Israel was one of the first countries to roll out a large scale COVID-19 vaccination campaign in December 2020, but has seen a resurgence of infections since June 2021. 

The research, carried out by the Research Institute of Leumit Health Services in Tel Aviv, confirms that the Pfizer-BioNTech vaccine provided excellent protection in the initial weeks after vaccination, but suggests that protection wanes for some individuals with time.

Examining the time elapsed since vaccination and risk of infection is needed to inform decisions about the need for a third injection, and its preferred timing.

The researchers examined electronic health records of 80,057 adults who had a PCR test for COVID-19 at least three weeks after their second injection. Of these 80,057 participants, 7,973 (9.6%) had a positive test result. These individuals were then matched to negative controls of the same age and ethnic group who were tested in the same week. 

The rate of positive results increased with time elapsed since a second dose. Across all age groups 1.3% of participants tested positive 21-89 days after a second dose, but this increased to 2.4% after 90-119 days; 4.6% after 120-149 days; 10.3% after 150-179 days; and 15.5% after 180 days or more.

After taking account of other potentially influential factors, the researchers found a significantly increased risk of infection with time elapsed since a second dose. 

Compared with the initial 90 days after a second dose, the risk of infection across all age groups was 2.37-fold higher after 90-119 days; 2.66-fold higher after 120-149 days; 2.82-fold higher after 150-179 days; and 2.82-fold higher after 180 days or more.

The researchers say they cannot rule out the possibility that other unmeasured factors, such as household size, population density, or virus strain may have had an effect. However, this was a large study of people who all received the same vaccine, and they were able to carry out detailed analysis of the data, suggesting the results are robust.

They conclude that in individuals who received two doses of the Pfizer/BioNTech vaccine, protection decreased over time, and the risk of breakthrough infection increased progressively compared with the protection provided during the initial 90 days.

The results suggest booster doses are warranted, the researchers say.

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