FDA Grants Full Approval to Novavax COVID-19 Vaccine with Restrictions

Strategic Insights -

The U.S. Food and Drug Administration has granted full approval to Novavax's COVID-19 vaccine, but only for certain groups. The vaccine, the only protein-based COVID vaccine available in the U.S., is approved for adults ages 65 and older, or for people ages 12 to 64 who have at least one health condition that puts them at higher risk of serious illness from COVID-19. Novavax's shot had only been allowed for emergency use in people 12 and up until now.

Key Takeaways:

  • The FDA has granted full approval to Novavax's COVID-19 vaccine, but only for adults ages 65 and older, or for people ages 12 to 64 with certain health conditions.
  • The vaccine is the only protein-based COVID vaccine available in the U.S.
  • The approval was granted despite the FDA asking Novavax to conduct more research, including a study on whether the vaccine is linked to any heart-related conditions.
  • A study on whether healthy people aged 50 to 64 benefit from taking a COVID vaccine is also part of the additional research.
  • Novavax's CEO, John Jacobs, stated that the company's commitment to the older population and those with underlying conditions is demonstrated by this approval.
  • The decision may signal that federal officials have already decided the course of action for COVID vaccine guidance.
  • The U.S. Centers for Disease Control and Prevention (CDC) advisers are set to vote on who should be encouraged to get yearly COVID shots.

Statistics:

  • 30,000: The number of people in the clinical trial that showed the vaccine was safe and effective.
  • 65 and older: The minimum age for which the vaccine is approved for full use.
  • 12 to 64: The age range for which the vaccine is approved for people with certain health conditions.
  • 12 and above: The minimum age for which the vaccine was allowed for emergency use.

Sources:

  • Associated Press, May 17, 2025