WASHINGTON — Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and toddlers from RSV, the respiratory virus that sends thousands of American children to the hospital each year.
The long-acting drugs from Merck and Sanofi are not vaccines, but 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 and said the FDA ''will update product labeling if warranted by the totality of the evidence.''
The two drugmakers said in separate statements 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.
News of the review was first reported by Reuters.
The drugs are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV. The FDA has approved vaccines for older patients and pregnant women but not babies or children, making the injections a first-line treatment for youngsters against the seasonal virus.
A spokesperson for Merck, maker of Enflonsia, said company representatives met with the FDA last week.
''We expect questions from the FDA, and we want them to ask,'' the company said. ''We believe deeply in the importance of transparency and we value the FDA's rigorous review of our clinical data of all of our products.''
