FDA and HHS Policy

NPR reports that pediatric infectious‑disease specialists are alarmed that the Food and Drug Administration has opened a new safety review into monoclonal antibody shots used to protect infants against respiratory syncytial virus (RSV), even after the products already cleared FDA vetting and were endorsed by the CDC. The story notes that more than half of U.S. babies have received one of the new long‑acting antibodies and that CDC data show the shots are about 80% effective at preventing intensive‑care admissions for RSV, the leading cause of infant hospitalizations in the first year of life. Doctors including Stanford’s Dr. Yvonne Maldonado and American Academy of Pediatrics infectious‑disease chair Dr. Sean O’Leary say hospitalizations have dropped sharply and accuse Health and Human Services Secretary Robert F. Kennedy Jr. of using FDA scrutiny and rhetoric about adverse‑event reports to sow unwarranted fear and "dismantle" immunization programs. The piece also reports that a federal judge in Boston has temporarily blocked Kennedy’s cuts to federally backed childhood vaccines and other new vaccine policies, deepening uncertainty over how the Trump administration will handle immunization guidance going forward. Vaccine‑skeptic advocates, such as Children’s Health Defense’s Brian Hooker, counter that reported fevers, seizures and some deaths justify the review, underscoring a widening clash between mainstream pediatric groups and Kennedy‑aligned activists over how to weigh rare adverse reports against population‑level benefits.