Federal health officials on Tuesday introduced a new regulatory approach that narrows Covid-19 vaccine approvals primarily to older adults and individuals with heightened vulnerability to the virus.
Under the updated policy from the Food and Drug Administration (FDA), seasonal Covid-19 vaccinations will continue to be offered to seniors and people with medical conditions that increase their susceptibility to serious illness. However, healthy children and younger adults, who face significantly lower risk of severe outcomes, will no longer be the focus of broad vaccine approval.
The policy shift was detailed in a paper authored by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research. Their findings were published in the New England Journal of Medicine.
“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: 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,” Makary and Prasad explained.
“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,” they added.
The authors argue that this updated stance aligns U.S. policy with that of countries like Canada, Australia, and several in Europe, which currently recommend boosters only for individuals at highest risk. While Makary and Prasad praised the development of the Covid-19 vaccine as a milestone in medical science, they expressed doubts about the benefits of repeated boosters for those at low risk.
Uptake of annual Covid-19 boosters in the U.S. remains low. Fewer than 25% of Americans have received the latest shot, with participation among children under 12 falling below 10%. Among healthcare professionals, only about one-third have gotten the booster, while half of adults over age 75 have done so, reports National Review.
According to Makary and Prasad, the revised approach will enable faster access to boosters for those who need them most, while giving researchers and regulators additional time to gather clinical data on broader population effectiveness. The Centers for Disease Control and Prevention notes that most Americans have at least one health condition that increases the risk of severe illness from Covid-19. These include obesity, diabetes, chronic lung disease, sickle cell disease, and compromised immune systems.
