Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax' protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

"We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We are grateful for the U.S. government's ongoing support and partnership to bring Novavax' COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization."

The Novavax COVID-19 vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

On June 7, 2022, the FDA's Vaccines and Related Biological Products Advisory Committee voted to recommend that the FDA grant an EUA for the Novavax COVID-19 vaccine for individuals aged 18 and over. The FDA is currently reviewing Novavax' application for EUA. If EUA is granted, a potential policy recommendation from the CDC would be the final step before immunizations with the Novavax COVID-19 vaccine could begin.

Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S.