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

By Eric December 4, 2025

In a significant move to bolster public health ahead of the upcoming fall vaccination campaigns, the U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations for the Pfizer and Moderna bivalent COVID-19 vaccines. This decision, announced on Tuesday, specifically allows individuals aged 65 and older, as well as certain immunocompromised individuals, to receive additional booster doses. The FDA’s action reflects a growing recognition of the need for enhanced protection among the most vulnerable populations as the nation prepares for a potential increase in COVID-19 cases during the colder months.

The bivalent vaccines, which target both the original strain of the virus and the Omicron variant, have already been pivotal in the fight against COVID-19. By permitting additional doses for older adults and those with weakened immune systems, the FDA aims to address concerns about waning immunity and the evolving nature of the virus. Studies have shown that older adults, particularly those with underlying health conditions, are at a higher risk of severe illness, hospitalization, and death from COVID-19. The decision underscores the importance of maintaining robust immunity in these groups, especially as new variants continue to emerge.

Healthcare experts have praised the FDA’s decision, emphasizing that these additional doses could help mitigate the impact of potential surges in COVID-19 cases this fall and winter. For instance, during the previous winter season, hospitals faced significant strain due to increased hospitalizations from COVID-19 and respiratory illnesses. The FDA’s proactive approach, coupled with ongoing public health campaigns to encourage vaccination, aims to minimize such pressures this year. With vaccination sites gearing up for the fall season, this amendment is a crucial step in ensuring that the most at-risk populations have the necessary protection against COVID-19, ultimately contributing to broader community health and safety.

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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