FDA Shifts COVID-19 Vaccine Policy, Requires Further Testing
FDA leadership says they expect more testing for COVID-19 vaccines and that they generate antibody titers in people in order for vaccines to be considered for approval.
In an article published this week in the New England Journal of Medicine, FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research (CBER), laid out their plan that will change the bar for how COVID-19 vaccines will be approved going forward.
They are seeing this through 3 groups: adults 65 years of age and older, those between the ages of 6 months and 64 years, and high-risk groups. They are taking a differing approach for each of them.
“On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe COVID-19 outcomes, as described by the CDC,” the authors wrote. “For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a COVID-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment.”
Makary and Prasad say the public has developed a mistrust in vaccines overall and they point to the reduced uptake of COVID-19 boosters in recent years as evidence as well as families refusing to get the MMR vaccine, which has led to a serious measles outbreak that has over 1,000 confirmed cases and led to 3 deaths in 2025.
“Less than 25% of Americans received boosters each year, ranging from less than 10% of children younger than 12 years of age in the 2024–2025 season to 50% of adults over 75 years old,” they wrote.
The authors point out that people in the 50–64-year-old age range would be the ideal group to study for future FDA-recommended placebo-controlled trials for COVID-19 vaccines.
For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.—Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH
They say their policy points out the need for evidence to prove if another booster will help a person who has had both COVID-19 and been vaccinated multiple times.
“The FDA’s new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people,” they write.
