Boost for Valneva as EMA accepts COVID19 vaccine filing

French specialty vaccine company Valneva (Euronext: VLA) has confirmed that the European Medicines Agency (EMA) has accepted the filing of a marketing authorization application (MAA) for Valneva’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001.

Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization application, the company confirms it would expect to receive a positive CHMP opinion in June 2022.

This brings a rare ray of positive news in Valneva’s quest to bring its vaccine to the market, well after leading product – Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) Comirnaty and several others - and comes just days after the French firm was notified that the European Commission was proposing to terminate the advance purchase agreement (APA) for Valneva’s VLA2001, unless progress was made on the product’s approval. Valneva’s shares gained 13% to 12.40 euros in early trading.