FDA Restricts Some COVID Vaccines to High-Risk Groups, But HHS Says Everyone Will Have Access

U.S. | Science & Health

20 hours ago

Originally posted by: Children's Health Defense

U.S. Health Secretary Robert F. Kennedy Jr. announced today in a post on X that the U.S. Food and Drug Administration (FDA) ended its broad authorization of COVID-19 vaccines, and is restricting the shots to people at higher risk for severe illness.

However, Kennedy also said the shots will be available to anyone who wants them, after consulting with their doctors. The U.S. Department of Health and Human Services (HHS) confirmed in an email to The Defender that today’s decision “does not affect access to these vaccines for healthy individuals. These vaccines remain available to those who choose them in consultation with their healthcare provider.”

The major change, according to HHS, is that shots were previously available under both emergency use authorization (EUA) and traditional approval, but now they are marketed only as fully licensed.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy said in his post.

I promised 4 things:

1. to end covid vaccine mandates.

2. to keep vaccines available to people who want them, especially the vulnerable.

3. to demand placebo-controlled trials from companies.

4. to end the emergency.

In a series of FDA actions today we accomplished…

— Secretary Kennedy (@SecKennedy) August 27, 2025

According to the X post, the COVID-19 shots from the three major vaccine producers — Pfizer, Moderna and Novavax — are now fully approved, for different ages, but only for people at higher risk from COVID-19 illness. That includes everyone over age 65.

The vaccine makers confirmed the approvals for their 2025-2026 shot formulas with the new limitations.

Prior EUAs still in place for the COVID-19 vaccines included Pfizer’s vaccine for children ages 6 months to 4 years. This will no longer be available. However, according to a press release Pfizer issued today, the shot is now fully licensed for people ages 5-64 at higher risk from COVID-19 and for all adults 65 and older.

In July, the FDA granted full approval of Moderna’s Spikevax for children ages 6 months and older.

In May, the FDA granted full approval to Novavax’s COVID-19 vaccine for anyone ages 12-64 at higher risk for COVID-19 and all adults 65 and older.

Commenting on the announcement, Children’s Health Defense (CHD) CEO Mary Holland said:

“While CHD’s view is that the mRNA shots are inherently unsafe and should not be on the market, we fully respect the Secretary’s promise fulfilled to keep the shots available for those who want them.

“The great news is that the Secretary’s announcement is likely to drive down demand even further, resulting in little more than a trickle of people still taking COVID boosters.”

Although Kennedy indicated others would be able to get the shot if they want, some have raised concerns about whether insurance plans will cover the shots for healthy children and adults.

The FDA has not yet issued a news release on the approvals.

Rates of COVID-19 vaccine uptake have dropped in recent years to an estimated 23% among all adults and 13% of people younger than 18, according to the CDC.

HHS also said in a Q&A shared with The Defender that the FDA revoked the EUA for COVID-19 convalescent plasma. The plasma remains available because the FDA has approved applications to manufacture COVID-19 convalescent plasma for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatments, according to HHS.

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Ending the emergency?

In his post, Kennedy also said the announcement ends the COVID-19 emergency.

However, the December 2024 amendment to the declaration under the PREP Act — which allows the health secretary to declare a public health emergency and grant immunity from liability to those involved in developing, distributing and administering medical countermeasures, such as vaccines, treatments and tests — issued by former Health Secretary Xavier Becerra, appears to remain in place.

That amendment extended the declaration of a public health emergency, or the potential for one, through 2029.

Many of the interventions that received EUA under that declaration, including the COVID-19 vaccines and treatments such as remdesivir, have now been fully approved by the FDA.

However, other interventions, including diagnostic tests, some personal protective equipment, and medical devices remain under EUA.

Commenting on the status of the emergency under HHS, Holland said, “There is some lack of clarity about what this means, and we look forward to further clarification.”

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