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FDA clears the way for additional bivalent boosters for certain vulnerable individuals

By Eric December 6, 2025

On Tuesday, the U.S. Food and Drug Administration (FDA) made a significant update to its emergency use authorizations for the bivalent COVID-19 vaccines developed by Pfizer and Moderna. This amendment specifically targets individuals aged 65 and older, as well as certain immunocompromised individuals, permitting them to receive additional booster doses ahead of the upcoming fall vaccination campaigns. This decision comes as health officials continue to emphasize the importance of maintaining robust immunity in these vulnerable populations, particularly as the virus continues to circulate and new variants emerge.

The FDA’s move is grounded in mounting evidence that older adults and those with weakened immune systems may benefit from enhanced protection against COVID-19 through additional vaccinations. Studies have indicated that immunity can wane over time, which raises the risk of breakthrough infections, especially for those in high-risk categories. By allowing these groups to receive extra doses, the FDA aims to bolster their defenses against severe illness, hospitalization, and death. For instance, data from the Centers for Disease Control and Prevention (CDC) suggests that older adults are significantly more likely to experience severe outcomes from COVID-19, making timely vaccination crucial.

This amendment comes as part of a broader strategy to ensure that the U.S. population remains protected as the fall season approaches, a time when respiratory viruses typically surge. Health officials are urging eligible individuals to take advantage of these additional booster shots, which are designed to target specific variants of the virus that have been prevalent. The FDA’s proactive approach reflects a commitment to public health and a recognition of the ongoing challenges posed by the pandemic. As vaccination campaigns ramp up, it will be essential for healthcare providers to communicate the benefits of these additional doses effectively, ensuring that those most at risk are adequately protected as we head into the colder months.

The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns.

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