FDA tightens COVID vaccine approval criteria for low-risk groups

Advertisement

The FDA released a new regulatory framework for COVID-19 vaccines that maintains the existing approval process for high-risk groups but sets more rigorous standards for healthy individuals under 65, moving away from the agency’s earlier one-size-fits-all approach.

Drugmakers will now need to provide stronger evidence, including clinical trial data showing reduced infections, hospitalizations or deaths before vaccines for low-risk individuals can receive full approval.

The updated shots will likely be available this fall for adults 65 and older, as well as anyone over 6 months old with at least one underlying condition that increases their risk —such as asthma, diabetes, cancer, obesity, or pregnancy, The Washington Post reported May 20. But it’s uncertain whether healthy individuals under 65 will be able to get the COVID-19 vaccine or have it covered by insurance.

The new guidelines, published May 20 in The New England Journal of Medicine and co-written by FDA Commissioner Martin Makary, MD, and Vinay Prasad, MD, director of FDA’s Center for Biologics Evaluation and Research, outlines the agency’s shift toward more targeted vaccine authorization. Under the new framework, immunogenicity data — evidence that a vaccine stimulates an immune response — will continue to support vaccine approvals for older adults and others at elevated risk of severe illness.

For healthy individuals ages 6 months to 64, however, the FDA will now require randomized, controlled trials demonstrating meaningful clinical outcomes. These include reductions in symptomatic infection, hospitalizations or more severe disease. The authors said that this change reflects growing uncertainty about the benefit of repeated boosters in low-risk populations.

“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. This policy will compel much-needed evidence generation,” Dr. Makary and Dr. Prasad wrote. 

The updated framework calls for trials that include participants with prior infection and a follow-up period of at least six months. 

Booster uptake in the U.S. has declined sharply in recent years. Fewer than 25% of Americans received updated COVID-19 shots in recent seasons, with even lower uptake among children and healthcare workers, according to CDC data cited in the article.

The CDC’s vaccine advisory panel is expected to meet in June to consider whether to update its recommendations in light of the FDA’s revised policy.

Advertisement

Next Up in Public Health

Advertisement