Novavax, Inc., a biotechnology company dedicated to the development and commercialization of next-generation vaccines for serious infectious diseases, today announced an agreement with the US Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to ensure the initial 3.2 million doses of Novavax’s COVID-19 vaccine (NVX-CoV2373) if it receives an Emergency Use Authorization (EAU) from the U.S. Food and Drug Administration (FDA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax’s protein-based vaccine will be made available free of charge to states, jurisdictions, federal partner pharmacies and federally qualified health centers.
“We are pleased to come one step closer to offering our vaccine to physicians, healthcare organizations and consumers awaiting a protein-based vaccine option”, “We are grateful for the US government’s continued support and partnership to bring Novavax’s COVID-19 vaccine to the US and look forward to the FDA’s decision on an emergency use authorization.”
Stanley C. Erck , president and CEO of Novavax
Novavax’s COVID-19 vaccine was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus’ Spike (S) protein and is formulated with Novavax’s patented saponin-based adjuvant Matrix- M™, to improve the immune response. Novavax’s COVID-19 vaccine contains purified antigen from the protein and cannot replicate, nor can it cause COVID-19.
On June 7, 2022, the FDA’s Vaccines and Related Biologicals Advisory Committee voted to recommend that the FDA grant an AUE for Novavax’s COVID-19 vaccine in individuals 18 years of age and older. The FDA is currently reviewing Novavax’s EUA application. If the AUE is granted, a possible policy recommendation from the CDC will be the final step before immunizations with Novavax’s COVID-19 vaccine can begin.