Vaccine Advisers Recommend New RSV Vaccine for Infants

A group of outside advisers to the Centers for Disease Control and Prevention (CDC) voted 5-2 to recommend the use of Merck’s new antibody vaccine, Enflonsia (clesrovimab), that can protect babies from respiratory syncytial virus (RSV), adding an additional tool against the most common cause of hospitalization in infants. Data presented at the meeting showed the approved interventions were safe and dramatically reduced hospitalizations among babies from RSV in the last respiratory virus season. 

The vote was the first for the newly assembled group, which was appointed by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. earlier this month after he dismissed the previous panel of 17 experts, claiming they had conflicts of interest. The split revealed tensions around the committee, some members of which have raised serious concerns from the public health community for their approach to vaccines and scientific evidence.

Enflonsia was approved earlier this month by the U.S. Food and Drug Administration, and the CDC committee’s recommendation was the next step in making it widely available for the coming RSV season, which typically begins in the fall. The recommendation now goes to the CDC director or potentially to Kennedy, as CDC nominee Susan Monarez, PhD, is still awaiting Senate confirmation.

The vaccine joins two other interventions already on the market to protect babies against severe disease from RSV. One, like clesrovimab, is an antibody shot, while another is a vaccine given during pregnancy.

The group also voted unanimously that Enflonsia should be included in the Vaccines for Children Program, which provides free vaccines to children whose families may not be able to afford them.