On May 20, 2025, the U.S. Food and Drug Administration (FDA) announced a significant policy change to its COVID-19 vaccine approval process, according to reports. Going forward, updated vaccines will primarily be limited for adults aged 65 and older, as well as individuals with underlying medical conditions that increase the risk of severe illness, such as diabetes, obesity, and asthma.

Under the new guidance, vaccine manufacturers seeking approval for use in healthy individuals aged six months to 64 years must submit data from randomized, placebo-controlled trials. These trials must demonstrate the vaccine’s effectiveness in preventing symptomatic COVID-19. This marks a departure from previous pandemic-era authorizations that allowed for faster emergency use approvals with more limited trial data.

The policy aligns the United States more closely with countries such as the United Kingdom, Canada, and Australia, which have shifted their vaccination strategies to focus on protecting high-risk populations. In those nations, updated COVID-19 shots are often recommended only for older adults and people with compromised immune systems.

However, the move has sparked concern among public health experts, who argue that limiting access to updated vaccines could reduce overall population immunity and leave room for future outbreaks, particularly in settings like schools and workplaces where younger, healthy individuals gather. Critics also worry that the decision may increase disparities, particularly among marginalized communities that already face barriers to healthcare access. 

“If they do not make it permissive — meaning that individuals who are not in a risk group or who are under 65 years of age want to be vaccinated — it’s likely now that payers will not pay for that vaccine,” said Michael Osterholm, a University of Minnesota infectious-disease expert who advised President Joe Biden’s transition team. “Therefore, in a sense, it’s the equivalent of taking away a vaccine from someone.”

Additionally, insurance coverage could be affected. With the new policy focusing on high-risk groups, individuals outside those categories may face out-of-pocket costs for COVID-19 vaccines, potentially further decreasing uptake rates.

Some health experts are urging the FDA to remain flexible in its approach, especially given the unpredictable nature of the virus and the ongoing emergence of new variants. They emphasize the importance of pivoting quickly if future data supports broader vaccination efforts.