US Government Signs COVID-19 Vaccine Pact With Novavax, With FDA Decision Still Pending

Novavax Inc NVAX has announced an agreement with the U.S. Department of Health and Human Services, in collaboration with the Department of Defense, to secure an initial 3.2 million doses of its COVID-19 vaccine.

The agreement is conditional on receiving FDA Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention. 

Novavax's protein-based vaccine will be free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

Related: Novavax' Sees Conditional Approval Of COVID-19 Vaccine Booster In Australia As US FDA Delays Its Decision.

"We are grateful for the U.S. government's ongoing support and partnership to bring Novavax's COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization," said Stanley Erck President & CEO of Novavax. 

Last month, the FDA's Vaccines and Related Biological Products Advisory Committee voted to recommend that the FDA grant a EUA for the Novavax COVID-19 vaccine for individuals aged 18 and over. The FDA is currently reviewing Novavax's application for EUA. 

Also, earlier today, the European authorities approved a second booster from mRNA-based vaccines, including shots from Pfizer Inc PFE & BioNTech SE BNTX, and Moderna Inc MRNA.

Last week, the EMA approved the expanded conditional marketing authorization for Novavax's COVID-19 vaccine for adolescents aged between 12 and 17.

Price Action: NVAX shares are down 3.42% at $73.52 during the premarket session on the last check Monday.

Photo by hakan german from Pixabay