The exterior view of the entrance to Merck headquarters in Rahway, New Jersey, on Feb. 5, 2024.
Spencer Platt | Getty Images
Robert F. Kennedy Jr.’s revamped government panel of outside vaccine advisors on Thursday recommended the use of Merck‘s shot to protect infants from respiratory syncytial virus, a temporary reprieve for public health officials and companies concerned about the Health and Human Services secretary’s immunization policy.
The group, called the Advisory Committee on Immunization Practices, or ACIP, also voted unanimously to include Merck’s shot in the government’s list of recommended 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, some of whom are well-known vaccine critics.
The signoff will allow the company to launch the shot ahead of the RSV season that typically kicks off around fall and winter and lasts through the spring. Enflonsia, recommended for infants during their first RSV season, will compete head-to-head with a rival shot from Sanofi and AstraZeneca called Beyfortus.
Both are preventative monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection. But each targets a different part of the virus, making it difficult to compare them directly.
ACIP’s “recommendations are an important step forward in efforts to help reduce the significant burden RSV continues to place on infants, families, and health care systems,” said Dr. Richard M. Haupt, Merck’s head of global medical & scientific affairs, vaccines and infectious diseases, in a statement.
RSV causes thousands of deaths among older Americans and hundreds of deaths among infants each year, and complications from the virus are the leading cause of hospitalization among newborns. In a mid- to late-stage trial on Enflonsia, the shot reduced RSV-related hospitalizations by more than 84% and decreased hospitalizations due to lower respiratory infections by 90% compared with a placebo among 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 some other members underscored the safety of Merck’s shot, which won approval from the Food and Drug Administration earlier this month.
“These are truly remarkable products. They are safe and they’re effective, and I don’t think there’s any further data that needs to be presented,” said member Dr. Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth.
The ACIP “work group has spent an enormous amount of time, the FDA has spent an enormous amount of effort looking at safety and efficacy, and it is simply not an issue here,” said Meissner, who has also held advisory roles at the CDC and FDA.
Other experts at the meeting, who aren’t members of the committee, agreed.
“This is a tremendous advance for medical science, and I urge the committee to approve and pass this resolution so that we can continue to protect our children 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 is not “ready to be administered to all healthy babies. He added, “I think we should 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.
