FDA Launches Safety Review of RSV Drugs for Babies and Toddlers
The Food and Drug Administration (FDA) has initiated a safety review of two injectable drugs used to protect babies and toddlers from Respiratory Syncytial Virus (RSV), a common and potentially life-threatening virus that affects thousands of American children each year. The drugs in question, developed by Merck and Sanofi, are not vaccines but rather laboratory-made versions of natural antibodies that help the immune system fight off RSV.
Background and Context
RSV is a seasonal virus that typically lasts five months and can be a coldlike nuisance for most healthy people. However, it can be life-threatening for the very young and the elderly. The FDA has approved vaccines for older patients and pregnant women, but not for babies or children, making these injections a first-line treatment for youngsters against RSV. According to the Centers for Disease Control and Prevention (CDC), in 2023, advisers recommended the antibody shots for infants born just before or during the RSV season, as well as for some 8- to 19-month-olds at higher risk of serious illness from RSV.
Government Review and Response
The government review comes as health officials and advisers under Health Secretary Robert F. Kennedy Jr. roll back recommendations on routine childhood vaccinations. A spokesman for Kennedy described the inquiry as a routine safety evaluation, stating that the FDA “will update product labeling if warranted by the totality of the evidence.” The two drugmakers, Merck and Sanofi, have stated that they haven’t seen any new safety signals with their medications, which were approved in recent years for infants and young children facing RSV.
Merck, the maker of Enflonsia, said company representatives met with the FDA last week, and the company believes deeply in the importance of transparency and values the FDA’s rigorous review of their clinical data. Sanofi, on the other hand, stated that it regularly submits any potential safety concerns to the FDA for review but hasn’t seen any new signals with its drug across more than 50 studies.
Implications and Concerns
The review has sparked concerns among medical and scientific professional societies, particularly given the recent decision by the CDC committee to urge an end to routine newborn vaccination against hepatitis B, a virus that can cause liver failure or liver cancer. The decision triggered swift backlash from numerous medical and scientific professional societies. Separately, officials at the FDA have been scrutinizing the safety of vaccines, particularly COVID-19 shots, and floated plans for a wholesale overhaul of the agency’s decades-old approach to approving and reviewing vaccines.
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