FDA Alert

FDA Limits COVID-19 Vaccine Access to People 65 and Older, High-Risk Populations

Kate Young

The FDA announced on Tuesday May 20, 2025, that it will limit access to COVID-19 vaccines to individuals aged 65 years and older, as well as those who are considered to be at high risk if they become infected. The FDA will also require manufacturers of the vaccine to conduct clinical trials to demonstrate the vaccines’ effectiveness in healthy younger adults and children.1

FDA commissioner Martin A. Makary, MD, MPH, and colleagues recently published a commentary in the New England Journal of Medicine, where they note that other high-income nations limit vaccine recommendations to older adults.

“The United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” they wrote. “The U.S. policy 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.”1

According to the CDC, about 49% of adults aged 75 years and older received at least one dose of the COVID-19 vaccine as of December 14, 2024, compared with only 30% in the previous year. Adults aged 65 to 74 years saw a similar increase in vaccination.2 Through its “Risk Less. Do More.” campaign, the U.S. Department of Health and Human Services has recommended that individuals aged 65 years and older and those at high risk prioritize getting the COVID-19 booster to mitigate risk of death, which is significantly higher in those cohorts compared with other populations.3

In the CDC’s “Interim Clinical Considerations for the Use of COVID-19 Vaccines in the United States”, published on May 12, 2025, the organization recommended that everyone aged 6 months and older receive the COVID-19 and that people of all ages stay up to date on their COVID-19 vaccination.4,5 The World Health Organization also recommends that health workers and pregnant individuals receive booster vaccinations in addition to elderly and immunocompromised patients.6

However, in their commentary, Makary and colleagues argue that poor annual uptake of the booster and eroding public trust in vaccination necessitate further proof that the benefits outweigh the risks, and as a result, the FDA will only permit access for those at high risk for severe COVID-19 outcomes.1

“The FDA’s new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” Makary and colleagues wrote. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”

References:

  1. Prasad V, Makary M. An evidence-based approach to Covid-19 vaccination. N Engl J Med. 2025;doi:10.1056/NEJMsb2506929
  2. COVID-19 vaccination rates among older adults are up from last season. https://www.cdc.gov/ncird/whats-new/covid-19-vaccination-rates-among-older-adults-are-up-from-last-season.html. Published Dec. 26, 2024. Accessed May 20, 2025. 
  3. About the campaign. https://www.hhs.gov/risk-less-do-more/about-campaign/index.html. Accessed May 20, 2025.
  4. Interim clinical considerations for use of COVID-19 vaccines in the United States. https://www.cdc.gov/covid/media/pdfs/2025/04/Interim-Clinical-Consideration-for-Use-of-COVID-19-Vaccines.pdf. Published May 12, 2025. Accessed May 20, 2025.
  5. Staying up to date with COVID-19 vaccines. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html. Accessed May 20, 2025.
  6. COVID-19 advice for the public: Getting vaccinated. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice. Updated Oct. 8, 2024. Accessed May 20, 2025.