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

By Eric December 1, 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 decision specifically targets individuals aged 65 and older, as well as certain immunocompromised individuals, allowing them to receive additional booster doses ahead of the upcoming fall vaccination campaigns. This proactive measure is part of a broader strategy to enhance protection against COVID-19, particularly as the virus continues to evolve and new variants emerge.

The FDA’s updated guidance reflects ongoing concerns regarding the effectiveness of the vaccines in older adults and those with weakened immune systems, who may not respond as robustly to initial vaccinations. The bivalent vaccines, which were designed to target both the original strain of the virus and the more recent Omicron variants, have proven to be crucial in reducing severe illness and hospitalization. By enabling these vulnerable populations to receive extra doses, the FDA aims to bolster their immunity, thereby reducing the risk of severe outcomes as they navigate the upcoming months, which may see a surge in COVID-19 cases.

This decision comes at a time when public health officials are urging communities to stay vigilant as colder months approach, traditionally associated with increased respiratory infections. The FDA’s move not only underscores the importance of vaccination in protecting high-risk groups but also signals a commitment to adapting the public health response as the pandemic evolves. With fall vaccination campaigns on the horizon, the availability of additional doses for those who need them most could play a key role in safeguarding public health and mitigating the impact of COVID-19 in the coming 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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