Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate

03 Jun'21

Valneva announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Over 4,000 volunteers in the United Kingdom have been randomized in the Phase 3 trial “Cov-Compare” (VLA2001-301), which compares Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria. Cov-Compare’s primary endpoint is 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. Topline data are expected by September 2021 and submission to the UK’s Medicines and Healthcare products Regulatory Agency for regulatory approval will follow, subject to the topline data.

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