Valneva: EMA accepts marketing authorisation application for
(CercleFinance.com) - Valneva confirms that the European Medicines Agency (EMA) has accepted the submission of the marketing authorisation application (MAA) for its candidate inactivated whole-virus vaccine against Covid-19, VLA2001.
VLA2001 thus enters the formal evaluation process by the Committee for Medicinal Products for Human Use (CHMP). If the CHMP accepts the conditional marketing authorisation application, Valneva could obtain a positive opinion from the CHMP in June 2022.
If the CHMP gives a positive opinion, the European Commission will review the recommendation and make a final decision on the MA, which would be valid in all EU Member States as well as Iceland, Liechtenstein and Norway.
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