FDA Reviews Injectable Drugs for RSV Protection in Children

Wed Dec 10 2025 06:30:17 GMT+0200 (Eastern European Standard Time)

The FDA is conducting a safety review of two injectable drugs aimed at preventing RSV in infants and toddlers, amidst shifting vaccination guidelines under Health Secretary Robert F. Kennedy Jr.

Health officials have initiated a safety review of long-acting injectable drugs from Merck and Sanofi that protect babies and toddlers from RSV, a virus responsible for numerous hospital visits each year. The review occurs against the backdrop of changing vaccination recommendations, with both companies stating they have not encountered new safety concerns with their products. RSV represents a significant health risk for young children, prompting the consideration of these treatments as a first line of defense. The implications of this review could affect ongoing vaccine strategies.

WASHINGTON (AP) — The Food and Drug Administration (FDA) has commenced a safety evaluation of two injectable drugs designed to shield infants and toddlers from Respiratory Syncytial Virus (RSV), a major cause of hospitalization among young children in the U.S.

The drugs, produced by Merck and Sanofi, are engineered antibodies that bolster the immune response against RSV, complementing existing vaccine options for older populations. This review is being conducted as health officials revise the routine childhood vaccination protocols under Health Secretary Robert F. Kennedy Jr.

A representative for Kennedy characterized the review as a standard safety protocol, emphasizing the FDA's commitment to transparency and thorough evaluation of clinical data. Both manufacturers, in response to the inquiry, assert that they have not observed any recent safety signals regarding their medications approved for young children.

Developed to protect infants during their critical first RSV season, which typically lasts around five months, these injections have become crucial in combating the seasonal virus. Recent CDC recommendations advocate for administering these shots to infants born just before or during RSV season, especially if their mothers were not vaccinated in late pregnancy.

Merck has stated it is prepared to answer questions from the FDA, highlighting its dedication to proper oversight. Sanofi, too, reported that it regularly communicates potential safety issues to the FDA but has found no alarming results from over 50 studies involving over 6 million infants administered with its drug.

RSV infections can resemble mild colds in otherwise healthy individuals, yet pose severe risks to very young children and the elderly. Following the recent changes in vaccination policies—such as the contentious recommendation to cease routine newborn hepatitis B vaccinations—this drug review signifies a pivotal moment in managing infectious diseases in vulnerable populations.

The FDA's review of these innovative treatments signals significant advancements in pediatric healthcare and underscores ongoing efforts to enhance child safety amid evolving public health strategies.