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Robert F. Kennedy Jr.’s improved government panel of external vaccine advisors on Thursday recommended use of MerckA shot to protect infants from respiratory syncytial virus. This is temporary tolerance for businesses involved in the vaccination policies of the public health authorities and the Secretary of Health and Human Services.
The group unanimously voted to include Merck’s shots on the government’s list of recommended pediatric vaccinations, known as the Advisory Committee on Immunization Practices, or ACIP, with a wide range of insurance coverage.
The vote in favor of Enfrusia, an injectable antibody, is a relief sigh for drugmakers and the medical community after Kennedy shot a panel earlier this month and hit a portion of it.
Sign-off allows the company to start shots before the RSV season. This usually kicks off around autumn and winter and continues until spring. Enflonsia, recommended for infants during the first RSV season, competes directly with rival shots from Sanofi and AstraZeneca It is called Beyfortus.
Both are prophylactic monoclonal antibodies that deliver antibodies directly into the bloodstream to provide immediate protection. However, direct comparisons are difficult because they target different parts of each virus.
RSV causes thousands of deaths among older Americans and hundreds of deaths among infants each year, and complications of the virus are the main cause of newborn hospitalizations. In a mid- to late-stage trial at Enflonsia, the shot reduced RSV-related hospitalizations by more than 84%, and reduced respiratory infections by 90% compared to placebo in babies up to 5 months.
Two vaccine critics on the panel, Retsef Levi and Vicky Pebsworth, voted against Merck’s recommendation for shots, questioning the safety during the meeting.
However, some other members highlighted the safety of Merck’s shot, which earned Food and Drug Administration approval earlier this month.
“These are truly remarkable products. They are safe and effective and I don’t think there’s any more data to present,” said Dr. Cody Meissner, professor of pediatrics at Geisel School of Medicine in Dartmouth.
ACIP: “Workgroups are spending a huge amount of time and the FDA has put in a huge amount of effort into considering safety and efficacy. It’s not a problem here.”
Other experts from the meeting who are not members of the committee agreed.
“This is a huge advancement in medicine and I urge the committee to approve and pass this resolution, so that we can protect our children and stay healthy.”
“I said I voted against the shot because I believe I am not ready to be managed by all healthy babies,” Levi said.
This vote recommends one Merck shot for babies under eight months of age during or entering their first RSV season.
