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

By Eric November 23, 2025

On Tuesday, the U.S. Food and Drug Administration (FDA) announced significant amendments to the emergency use authorizations for the bivalent COVID-19 vaccines developed by Pfizer and Moderna. This pivotal decision permits individuals aged 65 and older, along with those who have compromised immune systems, to receive additional doses of these vaccines ahead of the upcoming fall vaccination campaigns. The move comes as health officials prepare for a potential surge in COVID-19 cases as the colder months approach, emphasizing the importance of bolstering immunity among the most vulnerable populations.

The updated guidance aims to enhance protection for older adults and immunocompromised individuals, who are at a higher risk of severe illness from COVID-19. With the emergence of new variants, the effectiveness of vaccines can wane over time, making these additional doses crucial for maintaining robust immunity. The bivalent vaccines, which target both the original strain of the virus and newer variants, have shown promise in providing enhanced protection. For instance, studies indicate that these updated vaccines can significantly reduce the risk of hospitalization and severe disease, particularly in older adults, who often face the greatest health challenges from COVID-19. By allowing earlier access to booster doses, the FDA is responding to ongoing public health concerns and is aiming to ensure that those at greatest risk are adequately protected as they enter the fall season.

This amendment reflects a broader strategy to adapt vaccination efforts in response to the evolving landscape of the pandemic. As vaccination campaigns ramp up, public health officials are urging eligible individuals to take advantage of these additional doses to safeguard their health. The FDA’s decision underscores the importance of vaccination in controlling the spread of COVID-19 and protecting vulnerable populations, particularly as the nation navigates the complexities of living with the virus. As the fall approaches, the focus will likely shift to ensuring widespread vaccination uptake, which remains a critical tool in the fight against COVID-19 and its variants.

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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