EU regulator begins real-time review of Valneva’s COVID-19 injection – Community News
Covid-19

EU regulator begins real-time review of Valneva’s COVID-19 injection

The Valneva SE logo is pictured at the company’s headquarters in Saint-Herblain, near Nantes, France, on Sept. 13, 2021. REUTERS/Stephane Mahe

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December 2 (Reuters) – The European Union (EU) drug regulator said on Thursday it had begun a rolling review of French biotech company Valneva’s (VLS.PA) protein-based COVID-19 vaccine, weeks after the EU had signed a deal with the company for the supply of the shot.

The decision to initiate the real-time review was based on preliminary studies suggesting that the vaccine, VLA2001, triggers an antibody response against the coronavirus, the European Medicines Agency (EMA) said in a statement.

COVID-19 vaccines from Sinovac (SVA.O), Sanofi-GSK (SASY.PA), (GSK.L) and Russia’s Gamaleya Institute are also under EMA’s rolling review, which aims to accelerate potential approvals by studying data as it becomes available.

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The European Commission signed its eighth deal for a COVID-19 vaccine with Valneva last month, with the company providing up to 60 million doses of the injection over two years.

Valneva said in October that its vaccine showed efficacy “at least as good, if not better” than the injection of AstraZeneca (AZN.L) in a late-stage study comparing the two, with significantly fewer adverse side effects.

AstraZeneca’s vaccine is already approved in the EU, as are injections from Pfizer-BioNTech (PFE.N), (22UAy.DE), Moderna (MRNA.O) and Johnson & Johnson (JNJ.N).

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Reporting by Pushkala Aripaka in Bengaluru; Editing by Aditya Soni

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