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Valneva (NASDAQ:VALN) (OTCPK:INRLF) expects to receive a positive recommendation from the European Medicines Agency (EMA) in April for the conditional approval of its COVID-19 vaccine VLA2001.
The company said it has received a small set of additional questions from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which it intends to answer within days.
In February, Valneva had received a list of questions as part of the CHMP’s initial assessment to which it had responded.
The company added that a tentative timetable was received from the EMA, and subject to the CHMP’s acceptance of Valneva’s responses, it expects to receive the CHMP’s backing for conditional approval of VLA2001 for adults 18 to 55 years of age in April.
Valneva has an agreement with the European Commission (EC) to supply up to 60M doses of VLA2001 over two years, including 24.3M doses in 2022.
The company received the vaccine’s first approval in Bahrain a few days ago and had a prior agreement to supply 1M doses of VLA2001 to the country.
Valneva noted that it has begun manufacturing for the EC and Bahraini supply contracts and expects to deliver its first doses to Bahrain in March.
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