Federal health officials say the Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials first, a major shift in the agency’s approach to preventive measures for the disease.
The move, announced Tuesday in the New England Journal of Medicine by FDA Commissioner Martin Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, and other actions this week challenge conventional thinking on the effectiveness and risks for such vaccines.
The FDA’s change comes ahead of the agency’s Vaccines and Related Biological Products Advisory Committee meeting on Thursday, at which the panel will make recommendations for the strain selection for the 2025-26 COVID-19 vaccine rollout. The panel routinely makes such decisions in the spring to prepare for the fall, on a similar timeline as the annual flu vaccine program.
The advisory committee would typically be consulted before the agency moved forward with a vaccine policy change on this scale, health experts say. The CDC currently recommends COVID-19 shots for anyone age 6 months or older.
Prasad said in livestreamed remarks that the framework will include a “tremendously broad” category of those at risk, encompassing between 100 and 200 million people. He said underlying conditions like obesity, physical inactivity, mood disorders like depression and all immunocompromised conditions would be on the list. He said companies conducting research on COVID-19 vaccines in healthy adults and children should make sure their trials are at least six months long to determine how immunity wanes in the months following vaccination.
Moving forward, the agency envisions requiring a randomized trial for the vaccine every few years, but not every year, he said.
“We pushed too hard on low-risk populations, and we didn’t push hard enough on the at-risk populations,” Prasad said.
Some public health and epidemiology experts were skeptical of how the new policy will play out.
Emily Martin, a professor of epidemiology at the University of Michigan School of Public Health, said in an interview that she agrees “100 percent” that there should be more data on the age 50 to 64 group. But she said any effects shouldn’t be underestimated, as many healthy people in that range end up with significant impacts from COVID-19 infection.
Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine, said in a post on X on Tuesday that it wasn’t immediately clear how the risk pool would be determined, noting that the new framework didn’t take into account long COVID.
Building trust
The changes are meant to urge more research into the safety and effectiveness of the vaccine and build trust in vaccines more broadly, the officials said.
Makary and Prasad in the article pointed to other high-income countries in Europe, which recommend only that older people and those with underlying conditions receive an annual shot.
Randomized trials would determine the benefit in healthy people ages 6 months to 64 years, they said, underscoring that overall uptake of the COVID-19 vaccines has been poor over the past two seasons, with less than 25 percent of Americans receiving an updated shot for 2024-25, according to the CDC.
“There may even be a ripple effect: public trust in vaccination in general has declined resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective,” they wrote.
Martin said, however, that much of the data the FDA would be looking for has already been produced in studies after vaccines have been marketed for use. She pointed to a study in the Journal of the American Medical Association last year that found a reduction in illness and asymptomatic infections in school-age children after the COVID-19 booster shot. She said if a parent wants to vaccinate their child based on the available data, they should have the choice to do so.
Furthermore, Martin said the decision breaks with tradition on how vaccine recommendations are typically made. The FDA’s role is to determine whether the safety and efficacy of the vaccine supports the approval, while the CDC is responsible for determining which age groups it should be recommended for.
She said comparing the United States’ vaccine approach to that in Europe is like comparing “apples to oranges” because U.S. insurance coverage of vaccines is linked to FDA approval and the CDC’s recommendation.
“I think taking access away is never going to make something be used more,” she said.
The Centers for Disease Control recommends vaccination as a safer, more reliable way of building protection against the virus than getting sick. But the FDA announcement comes as challenges to that idea ramp up under the Trump administration.
Sen. Ron Johnson, R-Wis., chairman of the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations, on Wednesday convened a hearing on accusations that health officials had downplayed risks of the heart condition myocarditis and other health concerns following COVID-19 vaccination. Myocarditis is the medical term for inflammation of heart muscle, which can weaken the heart.
Johnson said getting to show this connection was just the first step. He issued an apology to “particularly to the vaccine injured” that the committee hadn’t moved quicker to hold a hearing.
“It didn’t pan out that way because, as dedicated as Robert F. Kennedy is to radical transparency in HHS, that’s hard to achieve,” he said, referring to the secretary of Health and Human Services.
Subcommittee ranking member Richard Blumenthal, D-Conn., responded that a report Johnson introduced showed no evidence that health officials were covering up risks but instead suggested they were working diligently to protect the public.
Meanwhile, the FDA on Wednesday posted letters that it had sent to vaccine makers in April, stating they would need to update their safety labels to include a warning about the risk of myocarditis.
And the FDA on Sunday granted full approval to Novavax’s protein-based COVID-19 vaccine, but only for people age 65 and older and people between the ages of 12 and 64 who have at least one underlying condition that puts them at high risk for severe disease.
Sandhya Raman contributed to this report.
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