The Franco-Austrian company has indicated that the EMA has accepted the submission of the marketing authorization dossier for its vaccine candidate VLA2001.
This new step means that VLA2001 "exits the process of progressive review of the data to enter the formal process of evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA", underlines the press release.
Valneva could therefore obtain a positive opinion from the CHMP in June 2022, the company says.
This new step is important for Valneva, in the context of its contract with the European Union.
The European Commission had indicated on Monday that it was considering terminating its contract to supply 60 million doses of vaccine against Covid.
The contract between the European Union and Valneva gave the European Commission the right to terminate it if the vaccine had not received an authorization for placing on the EMA by April 30, 2022.
However, according to the terms of the contract, “Valneva has 30 days from May 13, 2022 to obtain marketing authorization or propose a plan to remedy the situation in an acceptable manner”.
Valneva's vaccine uses proven inactivated virus technology, more traditional than the Pfizer/BioNTech and Moderna, messenger RNA vaccines.
VLA2001 has already received conditional marketing authorization in the UK.
It has also been authorized for emergency use in the United Arab Emirates and the Kingdom of Bahrain.
The course of Valneva, which had fallen by nearly 20% on Monday, regained ground Thursday morning, with an increase of 7.2% to 10.74 euros shortly after the opening of the Paris Stock Exchange.
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