Valneva Provides Regulatory Update on its COVID-19 Vaccine Candidate

Valneva SE has provided an update on the regulatory review of its inactivated, COVID-19 vaccine candidate, VLA2001, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

As announced on February 25, 2022, Valneva received a list of questions as part of the CHMP’s initial assessment to which it responded within two working days. Valneva said that it has now received a small set of additional questions and is confident it will be able to respond to these in the coming days.

With this additional round of questions and a tentative timetable also received from the EMA, and subject to the CHMP’s acceptance of Valneva’s responses, Valneva now anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022. Following such conditional approval, the company said it would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022, the company said.

Valneva signed an agreement with the European Commission (EC) in November 2021 to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 2022 and an option for delivery of the remaining doses in 2023. Valneva also signed an agreement with the Kingdom of Bahrain in December 2021 to supply 1 million doses of VLA2001. Valneva has commenced manufacturing for the EC and Bahraini supply contracts and expects to deliver its first doses to Bahrain in March 2022.