EU regulator begins rolling review of Sanofi’s new coronavirus vaccine

France is back in the vaccine race after the European Medicines Agency announced today it would begin assessing early data supporting Sanofi’s coronavirus vaccine.

France’s hopes of developing a working vaccine were derailed at the end of 2020 when Sanofi announced its original vaccine candidate failed to produce a strong immune response in older people in early human trials. The news was a national humiliation and raised questions about the country’s standing in medical research.

Sanofi went back to the drawing board, however, and created a reworked vaccine, Vidprevtyn. The candidate is a recombinant protein based vaccine — similar to the technology used by Novavax — that uses an adjuvant from GlaxoSmithKline to boost people’s immune response.

The EMA has now begun a rolling review, which allows regulators to assess data as it comes in. Its assessment is based on promising lab studies and early human trials that “suggest that the vaccine triggers the production of antibodies” that target the coronavirus that causes COVID-19 “may help protect against the disease.”

Sanofi, in partnership with GSK, began Phase 3 human trials of its vaccine at the end of May. At the time, the companies predicted the vaccine could be approved by regulators in the fourth quarter of 2021.

The EMA, however, wouldn’t provide a timeline today for when it could make a decision. The company will still have to submit a formal conditional marketing authorization application.

The agency currently has four vaccines undergoing rolling reviews, including Novavax, Sputnik, Sinovac and CureVac.

The EU has a contract with the company that allows countries to buy up to 300 million doses of the vaccine.

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This post originally posted here Coronavirus Search Results

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