Valneva Updates on COVID-19 Vaccine Candidate

 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today 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 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 would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022.

https://finance.yahoo.com/news/valneva-provides-regulatory-covid-19-060000284.html