WASHINGTON (AP) 鈥� Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect , the respiratory virus that 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. on routine childhood vaccinations.
A spokesman for described the inquiry as a routine safety evaluation and said the FDA 鈥渨ill update product labeling if warranted by the totality of the evidence.鈥�
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.
草莓传媒 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 and but not babies or children, making the injections for youngsters against the seasonal virus.
A spokesperson for Merck, maker of Enflonsia, said company representatives met with the FDA last week.
鈥淲e expect questions from the FDA, and we want them to ask,鈥� the company said. 鈥淲e believe deeply in the importance of transparency and we value the FDA鈥檚 rigorous review of our clinical data of all of our products.鈥�
Merck鈥檚 injection is approved to protect babies before or during their first RSV season, which typically lasts five months.
A spokesperson for Sanofi said it regularly submits any potential safety concerns to the FDA for review, but hasn鈥檛 seen any new signals with its drug across more than 50 studies.
鈥淎t this time, no safety issue has been identified from clinical studies of (Beyfortus) or from post-marketing experience with more than 6 million babies immunized worldwide,鈥� the company said in a statement.
An infection with RSV is a coldlike nuisance for most healthy people, but it can be life-threatening for the very young and the elderly.
In 2023, Centers for Disease Control and Prevention advisers for infants born just before or during the RSV season 鈥� if the birth mother wasn’t vaccinated late in pregnancy. The panel also recommended a dose for some 8- to 19-month-olds at higher risk of a serious illness from RSV.
Since taking over the Department of Health and Human Services, Kennedy replaced every member of the CDC committee, which also makes vaccine recommendations.
Last week, the panel urged an , a virus that can cause liver failure or liver cancer. The decision triggered swift backlash from numerous medical and scientific professional societies.
Separately, have been scrutinizing the safety of vaccines, particularly COVID-19 shots, and floated plans for a of the agency鈥檚 decades-old approach to approving and reviewing vaccines.
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