The US Food and Drug Administration (FDA) has announced a significant shift in its regulatory approach for COVID-19 vaccines, impacting vaccine manufacturers and potentially influencing the broader pharmaceutical industry.
The new framework, which differs from the previous “one-size-fits-all” policy, introduces stricter approval criteria, particularly for products aimed at individuals under the age of 65 without risk factors.
In a report published in The New England Journal of Medicine, FDA Commissioner Marty Makary and Vinay Prasad, head of the Center for Biologics Evaluation and Research, outlined the updated guidelines.
Vaccine developers will now need to produce clinical trial data to secure approvals for individuals under 65 years of age. However, for those aged 65 and above or with specific risk factors, data demonstrating antibody production may suffice to establish a positive benefit-risk ratio.
This regulatory adjustment mirrors recent constraints applied to Novavax’s protein-based COVID vaccine, restricting its use to older adults and younger individuals with underlying health conditions that increase the likelihood of severe disease.
Makary and Prasad have attributed this regulatory evolution to the reduced uptake of annual COVID boosters and waning public trust in vaccines. They emphasised that the new policy is designed to facilitate timely approvals across a broad population by recognising a wide range of conditions that elevate risk for severe COVID outcomes.
The duo stated: “Our policy also balances the need for evidence. 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.”
The revised framework demands comprehensive data from low-risk groups while ensuring expedited clearance for high-risk populations. This aligns with international practices and diverges from past US regulatory frameworks.
The announcement comes after indications from the Department of Health and Human Services that suggested an impending tougher stance on vaccine approvals. The department highlighted that all new vaccines would undergo safety testing in placebo-controlled trials before receiving licensure.
Although placebo testing is standard for new vaccines, yearly updates for flu and COVID vaccines have not typically required new efficacy data. Makary and Prasad clarified that the COVID vaccine policy is distinct from flu vaccine regulations due to differences in their mutational patterns.
Going forward, the FDA will require evidence that a vaccine can induce antibody responses to approve it for adults over 65 and individuals over six months old with Centers for Disease Control and Prevention (CDC)-recognised risk factors.
For healthy people aged six months to 64 years, randomised controlled trial data on clinical outcomes will be needed before granting biologics license applications.
The FDA’s vaccine advisory committee plans to convene on 22 May to assess updated COVID vaccine formulations from Moderna, Pfizer, and Novavax for the 2025-26 season. According to an FDA briefing document, updating vaccines to align with new strains could provide additional benefits as virus transmission is expected to rise during fall and winter.
