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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 amendment to the emergency use authorizations (EUAs) for the Pfizer and Moderna bivalent COVID-19 vaccines. This change allows individuals aged 65 and older, as well as certain immunocompromised individuals, to receive additional doses of the vaccines ahead of the upcoming fall vaccination campaigns. This decision comes as health officials are gearing up to combat a potential surge in COVID-19 cases as colder weather approaches and new variants emerge. The FDA’s move underscores the ongoing importance of vaccination in protecting vulnerable populations and enhancing immunity against the virus.

The bivalent vaccines, which were designed to target both the original strain of the virus and the more recent Omicron variants, have been pivotal in the fight against COVID-19. By expanding access to additional doses for older adults and those with weakened immune systems, the FDA aims to bolster the protection for these high-risk groups who are more susceptible to severe illness. Data from previous studies have shown that booster doses can significantly enhance immune responses, particularly in older adults whose immune systems may not respond as robustly to initial vaccinations. With the fall season often bringing increased respiratory illnesses, health officials are encouraging eligible individuals to take advantage of this opportunity to strengthen their defenses against COVID-19.

This proactive step by the FDA also reflects a broader strategy to maintain public health as the nation navigates the complexities of living with COVID-19. The Centers for Disease Control and Prevention (CDC) and other health organizations are expected to provide further guidance on the timing and availability of these additional doses. As vaccination campaigns ramp up, the focus will not only be on administering these bivalent vaccines but also on educating the public about the importance of staying up-to-date with vaccinations. With the ongoing evolution of the virus, the FDA’s decision marks an essential effort to ensure that the most vulnerable populations receive the protection they need to stay healthy this fall and winter.

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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