The external advisory group for the U.S. Centers for Disease Control and Prevention voted 5-2 to recommend the use of new shots that can protect babies against the most common causes of hospitalization in babies.
This vote was the first of a newly constructed group. This was first appointed after US Health and Human Services Secretary Robert F. Kennedy Jr. dismissed a previous panel of 17 experts earlier this month, claiming there was a conflict of interest. The division revealed tensions around the committee. Some members raised serious concerns from the public health community about their approach to vaccines and scientific evidence.
The shot, called Clesrovimab and brand name Enflonsia, is created by Merck and joins two other interventions already on the market to protect babies from severe illnesses from RSV. One, like Clesrovimab, is an antibody shot, and the other is a vaccine administered during pregnancy.
Data presented at the conference showed that approved interventions were safe and dramatically reduced hospitalizations for babies with RSV in the last respiratory virus season.
“As a pediatrician, I need people to understand that these results are epic achievements,” said ACIP Member, a professor of pediatrics at Dartmouth Geisel School of Medicine, on Wednesday. They “will have a huge impact on public health.”
The new drug was approved by the U.S. Food and Drug Administration earlier this month, and the CDC Committee’s recommendations were the next step to make it widely available for the upcoming RSV season, which usually begins in the fall. CDC candidate Dr. Susan Monares is still waiting for confirmation from the Senate, so now he is recommended to CDC Director or potentially Kennedy.
The vote comes after Dr. Retsef Levi, professor of operational management at the Massachusetts Institute of Technology Sloan Management and one of the new panelists, raised questions Thursday morning about whether there were any safety signals that occurred in clinical trials of antibody shots worthy of further scrutiny. Representatives from both the FDA and Merck highlighted the safety of the product and the rigour of clinical trials.
Meissner also expressed how the CDC panel workgroup on RSVs thoroughly investigated the data.
“We looked into the details very carefully. We are grateful for the careful review of Dr. Record (Levi’s) careful review, but the workgroup is pleased with the results of the various creslovimab trials,” he said.
Levi voted against the recommendation of Merckshot, joined by Dr. Vicki Pebworth, volunteer director of research and patient safety at the National Vaccine Information Center.
The vote was closely monitored as the first signal of how the new controversial committee approaches vaccination policies. The Advisory Committee on Vaccination Practices (ACIP) has a huge impact on how vaccines are used in the US, affecting insurance coverage and state policies.
Kennedy’s group tumultuous led an organization like the American Academy of Pediatrics this week to break concerns about scientific integrity with ACIP.
In its second vote at Merckshot on Thursday, the group voted unanimously that it should be included in the children’s vaccine program. This provides a free vaccine to children whose families may not be able to afford them.
