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COVID-19

FDA to Approve COVID-19 Vaccine Only for Older Adults and High-Risk Groups

Strategic Insights

— 2 min read

As the United States embarks on a new phase in its COVID-19 response, the Food and Drug Administration (FDA) has announced a significant shift in its stance on who should receive the COVID-19 vaccine. Effective May 20, 2025, the FDA will only approve new versions of the vaccine for adults 65 years of age and older, as well as individuals with one or more risk factors for severe COVID-19 outcomes, including medical conditions such as asthma, cancer, chronic kidney disease, heart disease, and diabetes. This change comes as the FDA seeks to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups.

Key Takeaways:

  • The FDA has changed its stance on who should receive the COVID-19 vaccine, limiting approval to adults 65 years of age and older, as well as individuals with one or more risk factors for severe COVID-19 outcomes.
  • The new framework is based on a risk-based approach, with the FDA aiming to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups.
  • The list of risk factors for severe COVID-19 includes medical conditions such as asthma, cancer, chronic kidney disease, heart disease, and diabetes, but also includes pregnancy and physical inactivity.
  • Caregivers and household members of people at high risk of severe illness from COVID-19 infection are not included on the list, leaving high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with.
  • The FDA is requiring vaccine manufacturers to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children.
  • Low-risk people will not have automatic access to the COVID-19 vaccine under the new framework, but health care providers can administer vaccines "off-label," which may necessitate additional costs and administration.
  • Existing vaccines on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall.

Statistics:

  • About 100 million to 200 million people in the US will fall into the high-risk category and will thus be eligible to get the vaccine.
  • Multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization, and death in low-risk adults and children.
  • Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID.
  • The FDA is moving to risk-based access for COVID-19 vaccines, which will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making.

Sources:

  • The Conversation U.S. article "FDA will approve COVID-19 vaccine only for older adults and high-risk groups — a public health expert explains the new rules"
  • New England Journal of Medicine article
  • FDA Commissioner Martin Makary and the agency's head of vaccines, Vinay Prasad, article published in the New England Journal of Medicine and in a public webcast

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