Doctors worry about FDA scrutiny of RSV shots to protect babies
SCOTT DETROW, HOST:
Health and Human Services Secretary Robert F. Kennedy Jr. just suffered a big legal setback on vaccines. A federal judge has blocked, at least for now, Kennedy's childhood vaccination schedule changes. So what's next for the Trump administration's immunization policies? NPR health correspondent Rob Stein takes a look at one possible move.
ROB STEIN, BYLINE: Kennedy still has lots of levers. He can pull on immunizations. One involves a shot babies get to protect against RSV. This highly contagious virus can be very dangerous for babies. In fact, RSV is the No. 1 reason infants end up in the hospital in their first year of life.
YVONNE MALDONADO: Some of these children are sometimes on ventilators or they can be on oxygen because they really can't breathe with this virus.
STEIN: Dr. Yvonne Maldonado is a pediatric infectious disease specialist at Stanford University.
MALDONADO: So it's quite severe in the very young. Some of these babies develop chronic lung disease from this infection and can develop asthma.
STEIN: But Maldonado says two new shots have been a game changer for protecting babies against RSV. These laboratory-made monoclonal antibodies fight infections like natural antibodies. More than half of eligible U.S. infants had gotten the shot, according to a CDC survey conducted in February.
MALDONADO: They're very new. But they've already had great success. The monoclonal antibodies have resulted in major reductions in hospitalizations for babies for RSV infection by about 70% to 80%. It's pretty remarkable.
STEIN: So Maldonado and other infectious disease experts were surprised and alarmed when the Food and Drug Administration launched a new review of the safety of these monoclonal antibodies. Dr. Sean O'Leary is with the American Academy of Pediatrics.
SEAN O'LEARY: These products were already thoroughly reviewed for safety, including by the FDA. The science and the facts will bear out that these are very safe products.
STEIN: O'Leary suspects the investigation is the latest step by Kennedy to undermine immunizations.
O'LEARY: It's more of the same. It's falsely promoting these safety risks that aren't real in the name of continuing to try and dismantle the U.S. vaccination program.
STEIN: The FDA has not said when the agency's review might be complete. Others welcome the investigation. Brian Hooker is the chief scientific officer for Children's Health Defense, an anti-vaccine group. He points to adverse reactions that have been reported among kids who got the shots, including fevers, seizures and even some deaths.
BRIAN HOOKER: I am concerned about the safety of these products. I think the entire safety profile, especially for this very vulnerable population, is worth taking a look at.
STEIN: The companies that make the shots, Sanofi and Merck, say they're cooperating with the FDA's review. They stress that the shots are very safe and there's no evidence that deaths or any other serious reactions were caused by the shots. Here's Ayman Chit from Sanofi.
AYMAN CHIT: The death of any child is a tragedy. But no deaths during our clinical studies were linked to the immunization. And this is not only our conclusion. The FDA itself, in analyzing all of our data, has come to the same conclusion.
STEIN: But many public health experts worry the FDA safety review could lead to restrictions that make it harder for babies to get the shots and discourage doctors or parents from protecting babies from RSV. So they're watching Kennedy's next moves to remake vaccine policies, especially amid White House worries about the political fallout of his unpopular restrictions.
Rob Stein, NPR News.
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