Valneva SE says it expects a positive recommendation from the European Medicines Agency for its adjuvanted inactivated whole virus Covid-19 vaccine for adults aged 18-55 by April 2022.
The company reported on Friday 11 March that its SARS-CoV-2 vaccine candidate (VLA2001) is still under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use, with a review date of 2 December 2021.
The EMA will need to be satisfied with the ongoing review of the vaccine before considering a formal application for conditional marketing authorisation by the company. The formal scientific evaluation phase will then begin and the EMA will decide on a recommendation for the vaccine. The European Commission will then decide whether to grant a conditional authorisation.
The EMA reportedly provided the firm with an indicative agenda and a series of additional questions. As a result, and subject to the green light from the European regulator, Valneva expects delivery of the first vaccine doses to the European market to be slightly delayed, i.e. “in the second quarter of 2022” rather than at the beginning of the second quarter.
Valneva had signed an advance purchase agreement with the European Commission on 23 November 2021 for the delivery of 27 million vaccine doses in 2022 (the company is now talking about 24.3 million doses), with an option to deliver an additional 33 million doses in 2023 and the possibility of adapting the vaccine to new variants.
For the EMA, it is still too early to decide on a concrete timetable. The European Commission highlights that the conclusion of the evaluation and the granting of the authorisation are prerequisites for the procurement and distribution of vaccines and for any practical consideration of distribution.
The company says it has started production of vaccines for the European market. (Original version in French by Emilie Vanderhulst)