FDA Taking Hard Look at Safety Data for RSV Shots for Babies (1)

December 9, 2025, 6:20 PM UTC

The US Food and Drug Administration is taking a closer look at RSV shots for infants as Health and Human Services Secretary Robert F. Kennedy Jr. continues to push for changes to the country’s childhood immunization schedule.

The FDA’s drug division is “rigorously reviewing the available data, as it does for all products,” HHS spokesman Andrew Nixon said. “FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence.”

The wording on a medication’s label impacts how widely it’s used.

Several drugmakers sell shots designed to protect babies against RSV, a common ...

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