Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S.

September 17, 2021

The U.S. Centers for Disease Control and Prevention (CDC) recently provided updated guidance stating that participants in the Novavax PREVENT-19 Phase 3 clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the active vaccine series. With this validation from the United States’ leading public health authority, Novavax expects our PREVENT-19 Phase 3 clinical trial participants will be considered fully vaccinated and in compliance with mandated vaccination policies, including those of employers and any other organizations or entities requiring proof of vaccination. Novavax is grateful to our clinical trial participants for helping to ensure a safer future for all, and we continue to advocate for them at the highest levels.  

Novavax is preparing to submit NVX-CoV2373, our protein-based COVID-19 vaccine to the U.S. Food & Drug Administration (FDA) for emergency use authorization. The CDC guidance does not imply that the vaccine has been approved or authorized by FDA or is recommended by CDC or ACIP.