The exterior view of the entrance to Merck headquarters in Rahway, New Jersey, on February 5, 2024.
Spencer Platt | Getty images
The renewed panel of the Government Government of External Vaccine Advisors of Robert F. Kennedy Jr. MerckThe shot to protect babies from the respiratory syncitial virus, a temporary respite for public health officials and companies concerned with the immunization policy of the Secretary of Health and Human Services.
The group, called Immunization Practices Advisory Committee, or ACIP, also voted unanimously to include Merck's opportunity in the recommended children's immunization government list that receive wide insurance coverage.
The votes in favor of the injectable antibody, Enflonsia, are a relief sigh for drug manufacturers and the medical community after Kennedy at the beginning of this month destroyed the panel and took advantage of the replacements, some of which are well -known vaccine critics.
The firm will allow the company to throw the shot before the RSV season that usually begins around autumn and winter and lasts during spring. Flonlonsia, recommended for babies during your first RSV season, will compete face to face with a rival shot of Healthy and Astrazeneca called Beyfortus.
Both are preventive monoclonal antibodies, which administer antibodies directly to the bloodstream to provide immediate protection. But each one points to a different part of the virus, which makes comparison difficult directly.
Acip's “recommendations are an important step forward in efforts to help reduce the significant burden that the RSV continues to place in babies, families and medical care systems,” said Dr. Richard M. Haupt, head of world medical and scientific affairs of Merck, vaccines and infectious diseases, in a statement.
The RSV causes thousands of deaths among older Americans and hundreds of deaths among babies every year, and virus complications are the main cause of hospitalization among newborns. In to Middle stage rehearsal in lateness, the shot reduced hospitalizations related to the RSV by more than 84% and decreased hospitalizations due to lower respiratory infections at 90% compared to a placebo among babies up to five months.
Two of the Vaccine's critics on the panel, Resef Levi and Vicky Pebsworth, voted against recommending Merck's shot and questioned their safety during the meeting.
But some other members stressed the security of Merck's shot, which obtained the approval of the Food and Drug Administration earlier this month.
“These are really notable products. They are safe and effective, and I don't think there are more data that are presented,” said Dr. Cody Meissner, a Pediatrics professor at the Geisel Medicine School in Dartmouth.
The Acip working group “has passed a huge amount of time, the FDA has spent a huge amount of effort by analyzing safety and efficiency, and it is simply not a problem here,” said Meissner, who has also had advice roles in the CDC and the FDA.
Other experts at the meeting, who are not 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 protecting our children and keep them healthy,” said Dr. Jason Goldman, president of the American Medical College.
Levi said he voted against the opportunity because he believes he is not “ready to be administered to all healthy babies. He added:” I think we should adopt a more candidate approach to this. “
The vote specifically recommends a dose of the Merck for Babies of 8 months or less born during or entering its first RSV season.
