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.
While preliminary laboratory studies demonstrate that three doses of the Pfizer/BioNTech COVID-19 vaccine can neutralise the Omicron variant, the initial two dose schedule shows significantly reduced neutralisation, the two companies said this week.
However, two doses may still induce protection against severe disease.
The companies are working on a variant-specific vaccine for Omicron and expect to have it available by March. If such a modification is required that will not impact the ability to manufacture four billion doses in 2022
The data, released on December 8, are the results from an initial laboratory study. They show blood samples from individuals who had received two doses of the current COVID-19 vaccine exhibited, on average, more than a 25-fold reduction in neutralising antibodies against the Omicron variant compared to wild-type that first emerged in Wuhan, and against which the vaccine was designed.
More robust protection may be achieved by a third dose, as data from additional studies indicate that a booster increases the antibody levels by 25-fold. According to the companies’ preliminary data, a third dose provides a similar level of neutralising antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron.
GlaxoSmithKline said Xevudy, its monoclonal antibody for treating COVID-19, has been shown to retain full activity in lab tests against the Omicron variant of SARS-CoV-2.
The data was generated through pseudo-virus testing of all the 37 mutations seen in Omicron, which are raising concern that the variant will be resistant to vaccines and antiviral drugs.
These findings build on the initial preclinical data published last week, showing Xevudy retained in vitro activity against key individual mutations of the Omicron variant, and add to the growing body of preclinical evidence demonstrating that Xevudy retains activity against all tested variants of concern.
Hal Barron, chief scientific officer of GSK said that from the outset it was hypothesised that Xevudy would have a high barrier to resistance. “These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the World Health Organisation, and we look forward to discussing these results with regulatory authorities around the world,” Barron said.
The European Medicines Agency is currently reviewing GSK’s application for marketing approval of Xevudy, which binds to a part of SARS-CoV-2 which is shared with its relative SARS-CoV-1. That indicates that the epitope is highly conserved, which may make it more difficult for resistance to develop.
Japanese pharmaceutical company Sosei announced its UK subsidiary Sosei Heptares has received a grant from the research charity Wellcome Trust to advance the preclinical development of oral antiviral drug targeting the main protease of SARS-CoV-2, an enzyme critical to replication of the virus, as a potential treatment for COVID-19.
Sosei Heptares initiated its COVID-19 R&D programme in April 2020, applying its structure-based drug design capabilities to selectively inhibit the protease. The most advanced candidate resulting from this research, SH-879, has demonstrated potent anti-viral activity against SARS-CoV-2 and potential for oral dosing, with a differentiated profile from other anti-viral drugs for COVID-19 that are either approved or in late stage development.
Work on SH-879 will now be accelerated with the support of the Wellcome grant, made through the COVID-19 Therapeutics Accelerator. The Accelerator was launched in March 2020 by Wellcome, Bill & Melinda Gates Foundation and Mastercard, to speed the development of COVID-19 therapeutics that address gaps in existing treatment research.
The European Medicines Agency said it has decided to start a rolling review of the French biotech Valneva’s COVID-19 vaccine, based on preliminary results from laboratory studies and early clinical studies in adults.
These studies suggest the vaccine triggers the production of antibodies that target SARS-CoV-2, EMA said.
The vaccine contains inactivated SARS-CoV-2 virus that cannot cause the disease, along with two adjuvants that are intended to strengthen the immune response to the vaccine.
Danish vaccines manufacturer Bavarian Nordic announced positive topline results from a phase II clinical trial of its COVID-19 vaccine candidate, ABNCoV2, showing it has potential to be used as a booster to other types of COVID-19 vaccines.
A total of 103 participants who had been previously vaccinated with mRNA or adenoviral COVID-19 vaccines were enrolled and received a single booster vaccination with ABNCoV2. At enrollment, around 57% either had no detectable neutralising antibodies and/or were below the levels that could be quantified, or were at levels reported to provide decreased levels of protection from COVID-19.
One week post vaccination with ABNCoV2, a 2-34-fold increase in the levels of neutralising antibodies against the Wuhan SARS-CoV2 variant was observed and peaked at two weeks with a 2-40-fold increase depending on the initial antibody levels.
However, all subjects, irrespective of whether they initially had very low, or high levels of neutralising antibodies were boosted to absolute antibody levels reported to be associated with a very high efficacy against COVID-19.
The same trend in terms of the fold-increases post the booster with ABNCoV2 was also observed for the Alpha, Beta and Delta variants.
Paul Chaplin, CEO of Copenhagen-based Bavarian Nordic, said the results confirm ABNCoV2 has, “the perfect profile” for a universal booster vaccine.
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.
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