FOOD and Drug Administration officials have opened an investigation into a common drug given to babies and toddlers.
The drug is used to prevent RSV, a respiratory virus that sends thousands of young children to the hospital every year.
The drug is not a vaccine, but the safety check comes as the FDA continues to roll back childhood vaccine recommendations under the leadership of Health Secretary Robert F. Kennedy Jr.
A spokesperson for RFK said the FDA “will update product labeling if warranted by the totality of the evidence.”
The medication, produced by drug companies Merck and Sanofi, are laboratory-made versions of natural antibodies that protect the immune system against RSV.
RSV presents as a common cold for most people, but can be deadly for babies and the elderly.
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Merck and Sanofi said in separate statements that they hadn’t seen any safety issues with their drugs.
A spokesperson for Merck said the company 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.”
A spokesperson for Sanofi added that the company regularly submits potential concerns about their drug to the FDA for review, and has not uncovered any issues.
“At this time, no safety issue has been identified from clinical studies of [the RSV injection] or from post-marketing experience with more than 6 million babies immunized worldwide,” the company said in a statement.
The Center for Disease Control and Prevention previously recommended the antibody shot for infants born during or just before RSV season, if the mother wasn’t vaccinated late in pregnancy.
It also recommended a booster shot for babies aged 8 to 19 months who are at an increased risk of catching RSV.
The CDC’s vaccine advisory board also scrapped the recommendation for all newborns to get the hepatitis B shot on December 5.
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