FDA steps away from COVID vaccines for healthy adults under 65

Healthy adults younger than 65 will no longer be eligible for COVID-19 shots starting in the fall, according to new federal guidelines announced Tuesday.

Vaccine manufacturers seeking approval for healthy adults now must conduct studies to determine whether their vaccine booster provides a benefit to that group, including those who have been previously vaccinated.

The current list of underlying medical conditions that put individuals at higher risk of severe COVID is broad, including diabetes, depression and obesity. The FDA estimates 100 million to 200 million Americans will still remain eligible for COVID boosters.

In announcing the new FDA Center for Biologics Evaluation and Research, director Dr. Vinay Prasad said during a livestream of the announcement that he was not concerned by the safety of the COVID vaccine, but its ability to provide tangible benefits for those who are otherwise healthy.

“The efficacy of repeat doses of the products of these vaccines to fully reduce the disease and symptomatic illness is uncertain,” Prasad said Tuesday during the livestream, adding that COVID vaccines were a “tremendous lifesaving advance.”

Prasad pushed back on claims the decision was influenced by HHS head Robert F. Kennedy Jr., saying he has never spoken to Kennedy and has not been pressured to take a particular action.

By focusing on those who are in the most need of vaccination – those 65 and older – Prasad told those watching that he hopes more Americans can be persuaded to get boosters. According to the CDC, fewer than 25% of Americans have gotten a COVID booster each year it has been available.

“The United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months. The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age and risk-based recommendations. We reject this view,” Prasad wrote in the New England Journal of Medicine.

Critics of the policy have said preventing vaccine uptake from healthy individuals who want it is a restriction on medical freedom on its own.

“This is overly restrictive and will deny many people who want to be vaccinated a vaccine,” Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, told the New York Times.

Determining whether people fall into one of the high-risk categories could also complicate efforts to ensure individuals COVID boosters.

“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary of the American Academy of Pediatrics.

Administration officials argue the United States’ previous policy is out of step with much of the world. While the United States recommended annual boosters for those 6 months and older, many nations only recommend them for those at higher risk or over 65.

But unlike the new U.S. policy, many of these countries did not prevent younger, healthy adults from being boosted. Australia – one of the more restrictive countries cited by the FDA – does not prevent healthy adults from receiving a COVID vaccine. The Australian government states vaccinating those 65 and older is “especially important,” but those over 18 are still “eligible.”

The FDA on Thursday will finalize the new rules and availability of COVID vaccines for the fall. Right now, it remains unclear how local availability and messaging around the COVID vaccine will change.

In a statement, Spokane Regional Health District spokesperson Kelli Hawkins said the district does “not know enough about how this decision will impact our COVID-19 vaccination efforts” until this meeting takes place and the U.S. Centers for Disease Control and Prevention make official recommendations.