In a significant policy shift announced Tuesday, the U.S. Food and Drug Administration (FDA) will no longer routinely approve annual COVID-19 shots for healthy younger adults and children, instead requiring manufacturers to conduct extensive placebo-controlled clinical trials before approval.
The new framework, published in the New England Journal of Medicine by FDA Commissioner Dr. Marty Makary and FDA vaccine chief Dr. Vinay Prasad, maintains streamlined approval processes only for adults 65 and older and individuals with at least one health condition that increases their risk of severe COVID-19.
"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," wrote Makary and Prasad, criticizing what they called America's "one-size-fits-all" approach to COVID-19 vaccination.
New Requirements for Vaccine Manufacturers
Under the new guidance, pharmaceutical companies must conduct clinical trials lasting at least six months for vaccines intended for healthy adults and children. These trials must demonstrate at least 30% effectiveness in preventing symptomatic COVID-19 infection.
This marks a significant departure from the previous approach, which allowed manufacturers to update COVID-19 vaccines annually using smaller immunogenicity studies, similar to the process used for seasonal flu vaccines.
The FDA officials estimate that between 100 million and 200 million Americans will still have access to updated vaccines through the streamlined approval pathway, including older adults and those with qualifying health conditions such as diabetes, heart disease, asthma, obesity, and certain mental health conditions.
Timing and Implementation Challenges
The timing of this announcement raises questions about the availability of updated COVID-19 shots for the upcoming fall and winter season. The FDA's vaccine advisory committee is scheduled to meet Thursday to recommend which viral strains should be targeted in the next round of vaccines.
However, the new requirement for placebo-controlled trials makes it virtually impossible for manufacturers like Pfizer and Moderna to complete the necessary studies in time for a fall rollout to healthy adults and children.
Dr. Paul Offit, vaccine expert at Children's Hospital of Philadelphia, expressed concern about the practical implementation of the new policy: "Is the pharmacist going to determine if you're in a high-risk group? The only thing that can come of this will make vaccines less insurable and less available."
Controversy and Criticism
The policy shift comes under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., who has appointed several outspoken critics of the government's COVID-19 vaccination strategy to key health agency positions.
Critics of the new approach argue that it inappropriately limits vaccine access and may preempt the normal advisory process of the Centers for Disease Control and Prevention (CDC), which typically makes recommendations about who should receive vaccines after FDA approval.
Dr. Jesse Goodman, former FDA chief scientist and professor at Georgetown University, questioned the agency's decision to limit people's "freedom to choose" vaccination, asking: "What about people with elderly or high risk relatives/housemates? What about people who are not at increased risk of severe disease who want to reduce their risk of infection or time off from work?"
Shift in Vaccination Strategy
The FDA officials defended their approach, suggesting that COVID-19 vaccines may not need annual updates. "Instead of having a Covid strategy that's year to year, why don't we let the science tell us when we should change?" Prasad said. "The virus doesn't have a calendar."
They also rejected the notion that Americans cannot understand age- and risk-based recommendations, writing: "This 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."
The policy change follows a similar unexpected limitation placed on Novavax's recently approved COVID-19 vaccine, which the FDA restricted to adults 65 and older and those with health conditions increasing their risk of severe illness.
For the upcoming respiratory virus season, these changes mean many Americans who previously received annual COVID-19 boosters may find themselves ineligible under the new guidelines, creating uncertainty about vaccine access as fall approaches.
