The Centers for Disease Control and Prevention’s influential panel of vaccine advisers Thursday approved updated recommendations for a new shot for respiratory syncytial virus, or RSV. It is also set to vote on recommendations for this year’s influenza vaccine.
Their votes mark the panel’s first official move after Health and Human Services Secretary Robert F. Kennedy Jr. fired the committee’s experts and replaced them with his own picks earlier this month.
Votes by the panel are closely watched by health authorities because they are tied to federal policies and programs that enable access to vaccines, including requirements for insurance coverage and funding to provide shots for uninsured children.
Other vaccines are also being discussed by the panel, but not voted on, including those for COVID-19, chikungunya and anthrax.
Kennedy’s new committee also announced Wednesday that it would start a renewed review of all recommended pediatric vaccines, over fears about the “cumulative effect” that the shots could be having on children. That includes weighing changes to recommendations for hepatitis B and measles vaccines given early in life.
The American Academy of Pediatrics denounced the move as sowing distrust in safe and effective immunizations, and warned Wednesday against curbing hepatitis B recommendations.
“Secretary Kennedy has given this committee a clear mandate to use evidence-based medicine when making vaccine recommendations, and that is what we will do. Vaccines are not all good or bad,” Dr. Martin Kulldorff, the panel’s chair, said Wednesday.
RSV shot
An RSV vaccine during pregnancy and another antibody shot called clesrovimab that can be given to newborns have previously been approved by the Food and Drug Administration and recommended by the CDC to prevent the disease.
The committee Thursday voted by a majority — five in favor, two against — to recommend a shot for newborns, branded as Enflonsia by Merck, adding another option to the already approved immunizations.
Two of the panel’s new members — Retsef Levi, an operations management professor at the Massachusetts Institute of Technology, and Vicki Pebsworth, the research director of a group focused on preventing vaccine injuries and deaths — voted against recommendations for the shot.
Pebsworth said she worried about coadministration of the shot with other childhood vaccines, despite data presented by the CDC’s Vaccine Safety Datalink showing that RSV antibody shots being given alongside other vaccines are not resulting in a safety risk.
Levi said that he was uncomfortable with clinical trial data he claimed suggested that deaths could be more frequent after use of the shots. He cited his experience as a parent, saying that “as a father, I can feel that I would be concerned.”
“I don’t feel this is ready to be administered to all healthy babies. I think we should take a more precautionary approach to this,” Levi said.
That was at odds with reviews by the CDC and FDA, which did not turn up evidence of this risk. An FDA official told the panel that the death rates — 0.3% versus 0.2% — were not significant, and that careful reviews of the deaths concluded that their causes were not related to the drug.
Another panel member, Dr. Cody Meissner of Dartmouth University, disagreed with Levi, warning that 80% of children hospitalized with RSV are healthy with no underlying conditions.
Meissner had previously participated in the deliberations of the committee’s work group as an outside adviser, before Kennedy purged its voting members.
“The work group has spent an enormous amount of time, the FDA has spent an enormous effort looking at safety and efficacy, and it is simply not an issue here,” he said.
Flu vaccines
The panel is also expected to vote on updated recommendations for influenza vaccines for the coming season, usually a routine annual affair for the committee before Kennedy’s purge.
This year is different also because Kennedy’s committee is now scheduled to vote on vaccines that use thimerosal, a preservative used in a small handful of shots that has been the subject of debunked claims about risks for autism and other neurodevelopmental disorders.
Thursday’s vote on thimerosal is scheduled to follow a presentation from Lyn Redwood, the former head of a group founded by Kennedy that has lobbied against vaccine authorizations and requirements. The group has been hired to work in the agency’s vaccine safety office.
