Valneva receives a positive opinion from the CHMP for the marketing authorization in Europe of its vaccine against Covid


The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization in Europe for the biotech vaccine candidate against Covid-19.

VALNEVA

Valneva receives a positive opinion from the CHMP for the marketing authorization in Europe of its vaccine against Covid | Photo credits: Valneva

To avoid speculation on the stock market, Valneva’s listing had been suspended since opening pending a press release, at 11.90 euros. The news should be appreciated.

The biotech announces, in fact, in the middle of the afternoon of Thursday, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a marketing authorization (MA ) in Europe of its inactivated whole-virus vaccine candidate against Covid-19 for use as a primary series in adults aged 18 to 50.

Unanimous decision

The European Commission will now review the CHMP recommendation and a decision on the marketing authorization application for VLA2001 in Europe is expected shortly. If granted, VLA2001 would be the first Covid-19 vaccine to receive standard type marketing authorization in Europe.

The CHMP concluded, with the unanimity of its members, after an in-depth assessment “ that the data on the vaccine were strong and met European Union criteria for efficacy, safety and quality “.

On June 13, Valneva had lost a quarter of its value in reaction to the announcement, by the biotech, according to which the supply agreement concluded with the European Commission on its vaccine candidate could be threatened for lack of sufficient volumes, this which could jeopardize the whole program.


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