Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001

Saint-Herblain (France), April 21, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

The Phase 3 trial “Cov-Compare”, (VLA2001-301), will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria¹, in a comparative immunogenicity trial.

Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).

Adam Finn, Chief investigator for the VLA 2001-301 program, Professor of Paediatrics at the University of Bristol and Consultant at the Bristol Royal Hospital for Children said, “Following very encouraging safety and immune response results from our Phase 1/2 trial, along with my investigator colleagues, I am really looking forward to starting on this important next stage of the clinical development of this important new vaccine. We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate.”

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “This Phase 3 initiation marks a significant milestone in the development of the only inactivated vaccine candidate against COVID-19 in clinical trials in Europe. As COVID-19 continues to impact people’s daily lives, we remain fully focused on developing another safe and efficacious vaccine solution. We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants. While Cov-Compare is progressing we are planning to conduct additional, complementary trials.”