The Trump administration is working to limit access to covid booster shots by creating more regulatory hoops for companies developing vaccines for “healthy persons.” The Food and Drug Administration (FDA) says it’s only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one “risk factor” for a severe case of covid-19.
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” FDA officials write in commentary laying out their plans in the New England Journal of Medicine (NEJM).
The move comes as notorious antivax crusader Robert F. Kennedy reshapes the US Department of Health and Human Services, recently pushing out the FDA’s top vaccine official and thousands of other federal health workers. Some public health experts are already voicing skepticism over whether the FDA’s new guidance for covid boosters will reap any benefits.
“This is overly restrictive and will deny many people who want to be vaccinated a vaccine.”
“This is overly restrictive and will deny many people who want to be vaccinated a vaccine,” Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email to the New York Times.
“The only thing that can come of this will make vaccines less insurable and less available,” Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children’s Hospital of Philadelphia, told The Associated Press.
The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. It says 100 to 200 million Americans will still have annual access to covid vaccines after its policy change. That would be less than 60 percent of the US population.
Last week, the agency approved the Novavax covid-19 vaccine for only older adults and people at higher risk from the disease.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” the NEJM commentary says.
But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention.
The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven’t been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA’s new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who’s at greater risk.
In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.
“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.
