The corporate stated that it’s assured that it is going to be in a position to answer the questions by the EMA’s Committee for Medicinal Merchandise for Human Use (CHMP) within the coming days.
Following the corporate’s response, the EMA will present a timetable in the direction of the conditional approval.
Valneva expects to obtain a optimistic CHMP opinion for conditional approval of VLA2001 to be used in adults 18 to 55 years of age, on the finish of Q1 2022.
Following such conditional approval, the corporate expects to ship the primary shipments of VLA2001 to European nations early in Q2 of 2022.
Valneva signed an settlement with the European Fee (EC) in November 2021 to produce as much as 60M doses of VLA2001 over two years, together with 24.3M doses in 20221. The corporate has started manufacturing for the EC and Bahraini provide contracts and has stock prepared for labelling and deployment upon regulatory approval.
Valneva is presently conducting extra scientific research aimed toward increasing the label and indications of VLA2001 to additional age teams, together with for potential use as a booster vaccine in 2022.