The Food and Drug Administration has approved updated COVID-19 shots for fall, implementing the tightest restrictions on who can access the vaccines since they became available.

Health and Human Services Secretary Robert F. Kennedy Jr. announced the approval Aug. 27 on social media platform X, saying that emergency-use authorizations for COVID-19 vaccines have been terminated and that the Moderna, Pfizer and Novavax immunizations are approved for "those at high risk."

Under the updated approvals, only those over 65 and people with existing health problems will be recommended for the COVID-19 vaccine, according to federal guidelines.

"These vaccines are available for all patients who choose them after consulting with their doctors," Kennedy said in the post.

HHS echoed the statement in a Q&A document shared with USA TODAY, saying, "Today’s decision does not affect access to these vaccines for healthy individuals. These vaccines remain available to those whochoose them in consultation with their healthcare provider.

"The transition is from a circumstance where vaccines have been marketed under both the emergency use pathway and the traditional approval pathway, to a circumstance where the COVID-19 vaccines are now marketed only under the traditional approval pathway," the document said. "This is not a removal of COVID-19 vaccines from the market."

Pfizer said in a news release that its updated shot was approved for use in all adults 65 and older and people older than 5 with at least one underlying condition that puts them at high risk for experiencing severe illness from COVID-19.

Moderna likewise said its updated Spikevax formula was approved for everyone over 65 and people 6 months and older with at least one underlying condition that puts them at high risk. Its new vaccine, mNEXSPIKE, was approved for people with an underlying condition ages 12 years or older and everyone over 65.

Rumors of vaccine ban are 'unfounded,' White House says

Kennedy said May 27 that the COVID-19 vaccine would no longer be included in the CDC's recommended immunization schedule for healthy children and pregnant women, a move that broke with expert guidance and bypassed the usual scientific review process.

Experts have warned that the new guidance could make it harder for others who want the COVID-19 vaccine, because insurance companies generally follow federal recommendations.

Speculation that Kennedy planned to ban the vaccine altogether circled in late August based on a report first published by The Daily Beast on Aug. 25. Citing cardiologist and Kennedy associate Dr. Aseem Malhotra, the report said the HHS would move to pull the COVID-19 vaccine off the U.S. market "within months," a claim the White House dismissed as "baseless speculation."

Medical organizations, doctors

The American Academy of Pediatrics, which recently exchanged words with Kennedy over vaccine recommendations, called the new guidelines "deeply troubling" in a statement released Aug. 27.

"Any parent who wants their child vaccinated should have access to this vaccine; today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children," academy president Dr. Susan J. Kressly said. "Parents and pediatricians, together, make the best decisions to protect children’s long-term health. We urge the Administration to allow these choices to remain with medical experts and families.”

Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at Brown University School of Public Health, likewise told USA TODAY that experts are worried about how federal agencies are communicating vaccine recommendations to the public.

"My biggest concern is that the confusion and concern these changes are fueling will, in practice, make it harder for people to get vaccines,” Nuzzo said.

Vaccine battle continues

Though the new, tighter guidelines have not reached the level of a ban, Kennedy's vaccine skepticism remains a point of contention between HHS and other health authorities.

State health departments and national professional organizations, including the American Academy of Pediatrics, American Medical Association, and the American College of Obstetricians and Gynecologists, publicly condemned Kennedy in May when he announced intentions to stop recommending the COVID-19 vaccine during pregnancy and for healthy children.

He later drew more backlash when he fired all 17 original members of the Advisory Committee on Immunization Practices, the committee of health experts that provides guidance on vaccine use to the CDC, replacing them with members whom critics have called unqualified. Some of the members, like Kennedy, have a history of anti-vaccine advocacy and involvement in anti-vaccine groups.

The American Academy of Pediatrics went as far as to release its own schedule Aug. 19, saying the federal process was no longer credible. It recommends that all children 6 months to 23 months old receive the latest COVID-19 vaccine to reduce the chance of serious illness. Children and adolescents ages 2 to 18, without other high-risk factors like immunosuppression, can receive and should be offered the vaccine if they were not immunized before, according to the guidance.

In a response posted to social media, Kennedy hit back at the pediatrics academy's criticism, implying that the organization's pro-vaccine views were influenced by corporate pharmaceutical funders.

Under Kennedy, updated CDC guidelines refrain from making recommendations and instead suggest parents consult with their child's pediatrician on a case-by-case basis.

This story has been updated with new information.

Contributing: Ken Alltucker

This article originally appeared on USA TODAY: RFK Jr.'s FDA approves new COVID vaccines with restrictions

Reporting by Mary Walrath-Holdridge, USA TODAY / USA TODAY

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