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

By Eric November 28, 2025

On Tuesday, the U.S. Food and Drug Administration (FDA) announced an important update to the emergency use authorizations for the bivalent COVID-19 vaccines developed by Pfizer and Moderna. This amendment permits individuals aged 65 and older, as well as certain immunocompromised individuals, to receive additional doses of these vaccines ahead of the upcoming fall vaccination campaigns. This decision comes as public health officials prepare for a potential surge in COVID-19 cases during the colder months, emphasizing the importance of bolstering immunity among the most vulnerable populations.

The FDA’s move is rooted in growing evidence that older adults and those with weakened immune systems may benefit from extra doses to enhance their protection against COVID-19. The bivalent vaccines, which target both the original strain of the virus and the more recent variants, have been pivotal in the ongoing fight against the pandemic. By allowing these groups to receive additional doses, health authorities aim to ensure that they maintain a robust defense against severe illness, hospitalization, and death related to COVID-19. This proactive approach not only seeks to safeguard individual health but also aims to alleviate potential burdens on healthcare systems as the nation braces for what could be a challenging fall and winter season.

As vaccination efforts ramp up, public health officials are urging eligible individuals to stay informed about their vaccination status and to take advantage of the additional doses. The FDA’s decision underscores the importance of adapting vaccination strategies to meet the evolving landscape of the pandemic, particularly as new variants continue to emerge. With the fall vaccination campaigns just around the corner, this amendment highlights a critical step in ensuring that the most at-risk populations are adequately protected as they navigate the ongoing challenges posed by COVID-19.

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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