PARIS (Agefi-Dow Jones) – Biotechnology company Valneva on Thursday confirmed the schedule for clinical trials and marketing authorization applications for its inactivated and adjuvanted vaccine candidate against Covid-19, VLA2001.
“As announced in December 2021, the company began the phased submission of initial marketing authorization applications for VLA2001 to the European Medicines Agency, UK MHRA and Bahrain NHRA” , Valneva said in a statement.
The biotech also continues to work “in close collaboration with these authorities so that they can complete their review process following the positive results of the Phase 3 trial”.
Potential regulatory clearances are still awaited during the first quarter and, subject to regulatory approval from the European Medicines Agency, Valneva still plans to deliver its vaccine to the European Union in April.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0) 1 41 27 47 31; [email protected] ed: VLV
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January 06, 2022 01:39 ET (06:39 GMT)