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Covid-19: LEMA accepts submission of Valneva’s vaccine authorization dossier | Photo credits: Valneva
PARIS (Agefi-Dow Jones)–The biotechnology company Valneva said on Thursday that the European Medicines Agency (EMA) had accepted the submission of the marketing authorization dossier for its inactivated whole-virus vaccine against Covid-19, VLA2001.
“The acceptance of the dossier means that VLA2001 is moving out of the progressive data review process and into the formal evaluation process by the EMA’s Committee for Medicinal Products for Human Use (CHMP), Valneva said in a press release. “If the CHMP accepts Valneva’s conditional marketing authorization application, the company confirms that it could obtain a positive opinion from the CHMP in June 2022”, added the biotech.
If the CHMP issues a positive opinion, the European Commission will then review the recommendation and make a final decision on the marketing authorization for VLA2001.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: VLV
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Dow Jones Newswires
May 19, 2022 01:45 ET (05:45 GMT)