The U.S. Food and Drug Administration plans to restrict this fall’s COVID-19 booster shots to Americans over 65 and those with risk factors for severe illness, citing the need for new clinical trials before expanding access to healthy individuals under 65.
FDA Commissioner Marty Makary and vaccines chief Vinay Prasad said Tuesday that approval for boosters in high-risk groups will proceed based on immune response data. They expect authorization for adults 65 and older, as well as anyone over six months of age with underlying conditions that increase the risk of serious COVID-19 outcomes.
For healthy people between six months and 64 years old, the FDA intends to require randomized, controlled trials—using saline as a placebo—to justify annual booster approval. Makary and Prasad argued in a New England Journal of Medicine article that such studies are necessary to ensure the shots are grounded in solid evidence.
“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,” they wrote. “This policy will compel much-needed evidence generation.”
Dr. David Boulware, an infectious disease expert at the University of Minnesota, called the policy reasonable, noting that drugmakers are unlikely to conduct the trials necessary for broader approval, citing cost and feasibility. “This is going to be hundreds of millions of dollars, so they’re not going to do the trial in a young population because the sample size would be huge to show benefit,” he said. “I think it’s unlikely to be done.”
Despite declining demand, COVID-19 vaccines remain a major revenue source. U.S. sales of boosters from Pfizer and Moderna totaled more than $3.5 billion in 2024.
