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FDA Gives Full OK to Novavax COVID Shot for High-Risk Groups

By I. Edwards HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on May 19, 2025.

MONDAY, May 19, 2025 — The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but only for certain people.

The vaccine is now 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, The Associated Press reported.

Novavax’s shot is the only protein-based COVID vaccine available in the U.S. Until now, it had only been allowed for emergency use in people 12 and up.

Unlike the mRNA vaccines from Pfizer and Moderna, which are approved for anyone 12 and older and authorized for kids as young as 6 months, Novavax will be limited to specific groups.

The FDA did not explain why it added these restrictions to Friday's approval, according to AP.

However, the move aligns with the views of U.S. Health Secretary Robert F. Kennedy Jr. and others in the Trump administration, who have expressed skepticism toward vaccination in the past.

In a statement, Novavax CEO John Jacobs said “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."

Novavax had expected full approval for broader use by April 1, after the FDA reviewed data from a 30,000-person clinical trial showing the vaccine was safe and effective. But instead of a broad approval, the FDA asked the company to conduct more research.

That includes a study on whether the vaccine is linked to any heart-related conditions, and another on whether healthy people aged 50 to 64 benefit from taking a COVID vaccine.

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) are set to vote on who should be encouraged to get yearly COVID shots, AP said. The Novavax decision may signal that federal officials have already decided what course of action they plan to take.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted May 2025

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