FDA Limits Annual COVID-19 Boosters To High-Risk Americans, Demands New Trials For Healthy Adults In Policy Shift Under RFK Jr.

The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.

What Happened: The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported Reuters.

“At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the U.S. Food and Drug Administration,” Prasad told FDA scientists during a live-streamed presentation on Tuesday. “We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose.”

See Also: Google Unveils ‘Total Reimagining Of Search’ With Chatbot-Style Feature To Compete With OpenAI

Why It Matters: This policy shift represents a significant departure from previous U.S. vaccination strategy, with Makary and Prasad noting that America has been more aggressive than other high-income nations in recommending yearly shots for healthy adults.

The decision comes amid shifting political priorities at the FDA under Health Secretary Robert F. Kennedy Jr., who has been remaking the U.S. health system to align with President Donald Trump‘s goal of dramatically shrinking the federal government.

This follows a pattern of increased scrutiny of vaccines, as evidenced by the FDA’s recent limited approval of Novavax Inc.’s NVAX COVID-19 vaccine only for people 65 and older and those 12 and up with underlying health conditions.

Despite the policy change, investors appeared reassured that vaccine policies for older and high-risk Americans remain unchanged. Shares of COVID-19 vaccine makers rose following the announcement, with Moderna MRNA up 6.06%, Pfizer PFE rising 2.22%, BioNTech’s BNTX U.S. ADRs up 4.1%, and Novavax gaining 1.5%.

Image Via Shutterstock

Read Next:

• Gary Black Compares Uber’s Shift To Driverless Cars With Netflix’s 2007 Move From DVDs To Streaming, Says Tesla ‘Faithful’ Are Missing The Bigger Picture

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.