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. 

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The logo for Merck is displayed on a screen at the New York Stock Exchange on Nov. 17, 2021.

Andrew Kelly | Reuters

Merck on Thursday said its experimental treatment designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing for approval of the shot. 

The pharmaceutical giant could emerge as a new competitor in the market for treatments against RSV, which causes thousands of deaths among older Americans and hundreds of deaths among infants each year. Complications from the virus are the leading cause of hospitalization among newborns, making Merck’s drug a valuable new treatment option if approved.

Merck plans to discuss the study data with regulators worldwide, with a goal of making the treatment available for infants as early as the 2025 to 2026 RSV season, according to a release. 

The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Merck presented the results at the medical conference IDWeek in Los Angeles.

The treatment 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, according to Merck. Clesrovimab also reduced lower respiratory infections that required medical attention by more than 60% compared with a placebo through five months.

RSV is a common cause of lower respiratory tract infections such as pneumonia. Results were consistent through both the five-month and six-month time points in the trial, Merck said.

The rates of adverse and serious side effects were comparable between patients who received Merck’s shot and those who took placebos in the trial. There were no treatment or RSV-related deaths in the study, the company added. 

“These promising results demonstrating decreased incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in helping to alleviate the continued burden of RSV on infants and their families,” Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude’s Children’s Research Hospital, said in Merck’s release. Ramilo is also an investigator working on the trials. 

Merck’s clesrovimab could potentially compete against a similar treatment from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand. Both are monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection. 

But Merck’s treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on an infant’s body weight. 

Last year, Pfizer and GSK rolled out RSV vaccines that are administered to expectant mothers who can pass on protection to their fetuses. 

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