Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate

Valneva SE a specialty vaccine company, today provided an update on the rolling review process of its inactivated, COVID-19 vaccine candidate, VLA2001, with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”).

Following last week’s meeting, the CHMP provided another List of Questions (“LoQ”). This LoQ includes requests for additional data and for further justification of a Conditional Marketing Authorization.

Valneva will respond to these requests in the coming days. If the CHMP accepts the submissions, the Company would expect a Conditional Marketing Authorization this quarter.

Valneva continues to believe that its inactivated vaccine meets the conditions for a Conditional Marketing Authorization, including a positive benefit-risk profile.  The Company remains focused on achieving a Conditional Marketing Authorization for VLA2001 in Europe after it was granted Conditional Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom (“UK”) two weeks ago.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval. VLA2001 is the only inactivated COVID-19 vaccine candidate in Europe, and we continue to receive messages every day from people who are looking for a more traditional vaccine approach”.

In its Phase 3 pivotal trial, Valneva demonstrated that two doses of VLA2001 induced superior neutralizing antibody levels and a significantly better tolerability profile compared to another EMA-approved vaccine (AZD1222). On April 14, 2022, the UK MHRA granted Conditional Marketing Authorization for VLA2001 for primary immunization in adults 18 to 50 years of ag. MHRA found that VLA2001 meets the required safety, quality and effectiveness standards. This authorization followed emergency use authorization from the Bahraini NHRA in March 2022.