sdecoret - stock.adobe.com
FDA framework ends universal COVID-19 booster recommendation
An updated FDA COVID-19 vaccine policy ends universal boosters and requires clinical outcome trials for individuals aged between 6 months and 64 years without risk factors.
On May 20, 2025, the FDA's Commissioner and the Center for Biologics Evaluation and Research director published an updated COVID-19 vaccine regulatory framework in The New England Journal of Medicine. The new framework replaces the prior universal booster approach with a risk-based strategy that differentiates approval requirements by population risk.
Moving forward, COVID-19 vaccines will continue to be authorized based on immunogenicity data for adults aged 65 and older and individuals over 6 months with one or more risk factors for severe COVID-19, according to the FDA.
These conditions include chronic kidney disease, obesity, cardiovascular disease, cancer, diabetes, pregnancy and certain mental health or immunosuppressive disorders, as defined by the CDC.
The FDA estimates this will cover between 100 million and 200 million Americans.
New clinical trial requirements
Based on the new COVID-19 vaccination regulatory framework, the FDA will now require randomized, placebo-controlled clinical trials demonstrating clinical benefit for healthy individuals aged from 6 months to 64 years without CDC-defined risk factors before granting Biologics License Applications.
These trials must assess reductions in symptomatic COVID-19, hospitalization or death and include participants previously infected with SARS-CoV-2. A six-month follow-up period is required to confirm the durability of protection.
The agency emphasized the 50–64 age group without comorbidities as an ideal population for upcoming clinical trials. Current authorizations for this group and younger healthy individuals will not be expanded without outcome-based data.
Declining booster uptake
The policy update follows declining public uptake of COVID-19 booster doses. According to CDC data cited in the article, fewer than 25% of Americans received a COVID-19 booster in the 2024–2025 season. Booster coverage was under 10% for children under 12, and fewer than one-third of healthcare workers participated in the 2023–2024 campaign.
The FDA stated that future vaccine applications will be evaluated individually using benefit–risk assessments and that the revised approach aims to support stronger clinical evidence and improve public trust in vaccination.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
