Post by : Badri Ariffin

The U.S. Food and Drug Administration has initiated a safety evaluation of two injectable treatments aimed at safeguarding infants and toddlers against respiratory syncytial virus (RSV), a prevalent yet potentially dangerous virus that results in hospital visits for thousands of young children annually.

Manufactured by Merck and Sanofi, these long-acting antibody therapies are not vaccines, but serve as crucial protection for infants and toddlers. Officials noted that this review is part of a routine assessment to guarantee the ongoing safety of these medications for general use.

While RSV generally manifests as mild, cold-like symptoms in healthy individuals, it can escalate to serious respiratory conditions in infants, young children, and older adults. Vaccines for older patients and pregnant women have already received FDA approval; however, these antibody shots remain the primary preventive measure available for infants.

Merck’s Enflonsia injection is typically given prior to or during an infant’s first RSV season, which lasts about five months. Meanwhile, Sanofi’s Beyfortus has been administered to over six million children around the globe. Both companies have indicated that no new safety issues have been reported from clinical trials or post-market evaluations.

The CDC has previously advised administering antibody shots to infants born just before or during RSV season, especially if the mother did not get vaccinated in late pregnancy. Additional recommendations apply to certain high-risk children aged 8 to 19 months.

This safety review unfolds amidst a wider examination of vaccine and drug safety protocols under Health Secretary Robert F. Kennedy Jr., who has recently made changes to the CDC's advisory committee and is considering adjustments to routine hepatitis B vaccinations for newborns.

FDA officials clarified that this review does not imply any confirmed safety problems. Depending on the outcomes of ongoing assessments, there may be updates to the product labeling.

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