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EU drug regulator starts reviewing new coronavirus vaccine

EU drug regulator starts reviewing new coronavirus vaccine
The European Union drug regulator says it has started a rolling review of a new coronavirus vaccine made by French startup Valneva

The European Union drug regulator said Thursday it has started a rolling review of a new coronavirus vaccine made by francês startup Valneva, the first step toward giving the vaccine the green light to be used in the 27-nation EU.

Approval by the Agência Europeia de Medicamentos would add another vaccine to the EU’s armory against COVID-19 as the bloc ramps up administering booster shots and some countries are preparing to deliver shots of Pfizer’s vaccine to children ages 5 para 11.

Mês passado, the EU’s executive commission approved a contract with Valneva for member nations to buy almost 27 million doses in 2022. The contract also included the possibility to adapt the vaccine to new variants of the coronavirus and to purchase up to 33 million more doses in 2023.

A rolling review is an accelerated way of assessing new drugs that allows European Medicine Agency experts to look at data from ongoing studies as they become available. Once sufficient data is available, the company can submit a formal application for EMA marketing authorization.

The Amsterdam-based agency did not give a time frame for possible approval of the Valneva vaccine.

Em setembro, the U.K. government canceled an agreement with Valneva, partly because it was clear the company’s COVID-19 vaccine wouldn’t be approved by British regulators, the U.K. health secretary said.

The EMA is now carrying out rolling reviews of four COVID-19 vaccines, including Russia’s Sputnik shot and China’s Sinovac.

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