RFK Jr. CDC vaccine panel backs Merck RSV shot for infants

Robert F. Kennedy Jr.’s revamped government panel of outdoor vaccine advisors on Thursday beneficial the usage of Merck‘s shot to guard infants from respiratory syncytial virus, a brief reprieve for public health officials and firms concerned concerning the Health and Human Services secretary’s immunization policy.

The group, called the Advisory Committee on Immunization Practices, or ACIP, also voted unanimously to incorporate Merck’s shot in the federal government’s list of beneficial childhood immunizations that receive wide insurance coverage.

The votes in favor of the injectable antibody, Enflonsia, are a sigh of relief for drugmakers and the medical community after Kennedy earlier this month gutted the panel and tapped replacements, a few of whom are well-known vaccine critics. 

The signoff will allow the corporate to launch the shot ahead of the RSV season that typically kicks off around fall and winter and lasts through the spring. Enflonsia, beneficial for infants during their first RSV season, will compete head-to-head with a rival shot from Sanofi and AstraZeneca called Beyfortus.

Each are preventative monoclonal antibodies, which deliver antibodies directly into the bloodstream to supply immediate protection. But each targets a unique a part of the virus, making it difficult to check them directly.

RSV causes hundreds of deaths amongst older Americans and a whole lot of deaths amongst infants every year, and complications from the virus are the leading explanation for hospitalization amongst newborns. In a mid- to late-stage trial on Enflonsia, the shot reduced RSV-related hospitalizations by greater than 84% and decreased hospitalizations because of lower respiratory infections by 90% compared with a placebo amongst infants through five months.

Two of the vaccine critics on the panel, Retsef Levi and Vicky Pebsworth, voted against recommending Merck’s shot and questioned its safety throughout the meeting. 

But another members underscored the security of Merck’s shot, which won approval from the Food and Drug Administration earlier this month. 

“These are truly remarkable products. They’re protected and so they’re effective, and I do not think there’s any further data that should be presented,” said member Dr. Cody Meissner, a professor of pediatrics on the Geisel School of Medicine at Dartmouth. 

The ACIP “work group has spent an unlimited period of time, the FDA has spent an unlimited amount of effort safety and efficacy, and it is solely not a problem here,” said Meissner, who has also held advisory roles on the CDC and FDA.

Other experts on the meeting, who aren’t members of the committee, agreed. 

“That is an amazing advance for medical science, and I urge the committee to approve and pass this resolution in order that we will proceed to guard our youngsters and keep them healthy,” said Dr. Jason Goldman, president of the American College of Physicians. 

Levi said he voted against the shot because he believes it just isn’t “able to be administered to all healthy babies. He added, “I believe we must always take a more precautionary approach to this.”

The vote specifically recommends one dose of Merck’s shot for infants ages 8 months or younger born during or entering their first RSV season.