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

By Eric November 24, 2025

In a significant update to its emergency use authorizations, the U.S. Food and Drug Administration (FDA) has expanded access to the Pfizer and Moderna bivalent COVID-19 vaccines for specific populations. As of Tuesday, individuals aged 65 and older, along with those with compromised immune systems, can receive additional booster doses ahead of the upcoming fall vaccination campaigns. This decision comes as public health officials aim to bolster immunity in vulnerable groups as the COVID-19 virus continues to circulate, particularly with the onset of colder months when respiratory illnesses typically rise.

The bivalent vaccines, which target both the original strain of the virus and the more recent Omicron variants, have been pivotal in the ongoing fight against COVID-19. By allowing older adults and immunocompromised individuals to receive these additional doses, the FDA is responding to evidence suggesting that these populations may experience waning immunity over time, making them more susceptible to severe illness. For instance, studies have indicated that older adults have a higher risk of hospitalization and death from COVID-19, emphasizing the need for robust vaccination strategies tailored to their needs. The FDA’s amendment aims to mitigate these risks by ensuring that these groups have access to the most effective protection available.

As the fall vaccination campaigns approach, this proactive measure underscores the importance of staying ahead of potential COVID-19 surges. Public health experts are urging eligible individuals to take advantage of these additional doses to enhance their protection. The FDA’s decision is not only a response to the current epidemiological landscape but also reflects a broader strategy to maintain public health resilience against COVID-19 as new variants emerge. Ultimately, this move is expected to play a crucial role in safeguarding the health of some of the most vulnerable members of the community as they navigate the challenges posed by the pandemic.

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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