Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe
Saint Herblain (France), June 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.
The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
The CHMP concluded by consensus after a thorough evaluation that, “the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.”
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are pleased that the CHMP has recommended VLA2001, the only inactivated COVID-19 vaccine candidate in Europe, for full marketing authorization and are now looking forward to receiving marketing authorization from the EC. I would like to personally thank all those who have supported us in this endeavor, as well as everyone at Valneva for all their hard work. We hope that the EC and its member states will recognize the potential advantages of an inactivated vaccine and make a meaningful order, since we have clear evidence that Europeans are seeking a more traditional vaccine technology. Our aim is to further support public health in Europe by providing a new option for the 15% of Europeans over 18 who are not yet vaccinated1.”
Once granted by the EC, the marketing authorization would be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.
The EMA’s CHMP opinion follows conditional marketing authorization in the United Kingdom, which was granted in April 20222, and emergency use authorization granted in the United Arab Emirates in May 2022 and in Bahrain in March 2022.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.