Advisers to the Centers for Disease Control and Prevention (CDC) this morning voted to recommend all newborns receive Merck’s new monoclonal antibody shot, designed to protect against respiratory syncytial virus (RSV).
Two of the seven committee members, Retsef Levi, Ph.D., and Vicky Pebsworth, Ph.D., opposed the recommendation, citing safety concerns. The remaining five members supported it.
The vote marked the first — and closely watched — decision by the new members of the Advisory Committee on Immunization Practices (ACIP), appointed early this month by U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. He replaced all 17 sitting members, citing long-standing conflicts of interest that he said had plagued the committee for years.
Kennedy’s decision outraged the mainstream public health industry, which feared the new committee would be more critical of vaccines. It even prompted a move by vaccine manufacturers, insurers and the professional medical organizations they support to bypass government health agencies’ recommendations by creating a nongovernmental system for recommending and purchasing vaccines.
The U.S. Food and Drug Administration earlier this month approved Merck’s RSV shot, clesrovimab, which will be marketed as Enflonsia. It joins two other recently approved RSV drugs. One is Sanofi and AstraZeneca’s monoclonal antibody shot for infants, Beyfortus (nirsevimab). The other is Pfizer’s RSV vaccine, Abrysvo, for pregnant mothers.
Data presented by the CDC during Wednesday’s ACIP meeting reassured committee members that the recently approved RSV interventions were safe and effective.
However, an analysis of the CDC’s Vaccine Safety Datalink for the 2023-2024 respiratory season revealed an association between Abrysvo and an increased risk for hypertensive disorders of pregnancy, which include gestational hypertension, preeclampsia, eclampsia and HELLP syndrome, a life-threatening pregnancy complication.
Presenters repeatedly emphasized that RSV — a common respiratory virus that usually causes mild cold-like symptoms but can be serious in infants — is the leading cause of hospitalization for infants in the U.S. There are fewer than 100 deaths per year from RSV in the U.S., according to data presented at the meeting.
Hellbound and Down 