Valneva SE (VALN)

[p0]

EMA starts accelerated review of Valneva vaccine approval/
Marketing authorisation application

The European Medicines Agency (EMA) has announced an accelerated review for Valneva's Corona vaccine. The review of the VLA2001 vaccine has already begun, the Amsterdam-based EU agency announced Thursday. When a decision on the inactivated vaccine from the Austrian-French biotechnology company will be made is still open, it said.

Valneva's inactivated vaccine contains killed components of the coronavirus for immunization. As such, it uses similar technology to traditional flu vaccines and is said to be able to be stored in normal refrigerators. In October, Valneva had announced "positive" initial results from its Phase 3 clinical trial of the vaccine. The drug was more effective than the AstraZeneca vaccine, it said, and "generally well tolerated."

Even before an approval, the EU Commission had signed a supply agreement with Valneva. The Commission said less than a month ago that the agreement provides for the supply of up to 60 million Corona vaccine doses over the next two years, if the EMA actually approves the drug. Announcing the agreement, EU Commission President Ursula von der Leyen stressed that the vaccine could be adapted to new Corona variants. This could be important, not least in view of the new coronavirus variant Omikron.
(diepresse.at)

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News 02/12/2021
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-valnevas-covid-19-vaccine-vla2001
(While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.)