valneva: EU drug regulator starts reviewing new coronavirus vaccine


The European Union drug regulator said on Thursday it has started a rolling review of a new coronavirus vaccine made by French startup Valneva, the first step toward giving the vaccine the green light to be used in the 27-nation EU. Approval by the European Medicines Agency 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 to 11.

Last month, 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.

In September, the UK government cancelled an agreement with Valneva, partly because it was clear the company’s COVID-19 vaccine wouldn’t be approved by British regulators, the UK 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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