EU regulator begins real-time review of Valneva's COVID-19 shot

The European Union's drug regulator said on Thursday it had started a rolling review of the protein-based COVID-19 vaccine from French biotech firm Valneva, weeks after the EU signed a deal with the company for supplies of the shot. The decision to start the real-time review - which could speed up approval of the shot - was based on preliminary studies that suggest the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said in a statement.

The European Union's drug regulator said on Thursday it had started a rolling review of the protein-based COVID-19 vaccine from French biotech firm Valneva, weeks after the EU signed a deal with the company for supplies of the shot.

The decision to start the real-time review - which could speed up approval of the shot - was based on preliminary studies that suggest the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said in a statement. https://www.ema.europa.eu/en/news/ema-starts-rolling-review-valnevas-covid-19-vaccine-vla2001 Valneva said it was hopeful its vaccine candidate would cross protect people against variants of the virus, adding it would test it specifically against Omicron.

"Valneva believes that VLA2001 can make an important contribution to the global fight against the COVID-19 pandemic and potentially play a role in protecting against the new Omicron variant," the company said. COVID-19 vaccines from Sinovac, Sanofi-GSK and Russia's Gamaleya Institute are also under the EMA's rolling review, which aims to speed up possible approvals by studying data as it becomes available.

Unlike vaccines by Pfizer-BioNTech , AstraZeneca, Johnson & Johnson and vaccine candidate Novavax, the Valneva shot exposes the immune system to the entire coronavirus, not just the spike protein. Experts hope that could potentially make the immune response to that shot less sensitive to large mutations on the spike protein.

The European Commission last month signed its eighth deal for a COVID-19 vaccine https://www.reuters.com/business/healthcare-pharmaceuticals/french-company-valneva-wins-deal-with-european-commission-over-covid-19-vaccines-2021-11-10 with Valneva, under which the company would supply up to 60 million doses of the shot over two years. Valneva said in October its vaccine demonstrated efficacy "at least as good, if not better" than AstraZeneca's shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.

AstraZeneca's vaccine is already approved in the EU, as are shots from Pfizer-BioNTech, Moderna and Johnson & Johnson.

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