On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine.

The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes.

However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups.

FDA Commissioner Martin Makary and the agency’s head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast.

The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public.

Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk.

According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends – specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread.

The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups.

The FDA’s decision to adopt a risk-based framework........

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