Friday, 04 July 2025

CDC Vaccine Advisory Panel Recommends Merck’s RSV Shot For Infants Despite Safety Concerns

100 Percent Fed Up
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In a controversial decision, the Advisory Committee on Immunization Practices (ACIP) voted on Thursday to recommend Merck’s monoclonal antibody shot against respiratory syncytial virus (RSV) for infants up to one year of age.

The panel, which advises the Centers for Disease Control and Prevention (CDC) on the vaccine schedule, held its first meeting since Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. retired prior members.

HHS Secretary Robert F. Kennedy Jr. Appoints Robert Malone, Others To Vaccine Advisory Panel

The committee voted 5-2 to recommend the use of Merck's shot.

CNN shared additional details:

The advisers also voted 5-2 on Thursday to recommend the use of a new shot that can protect babies from respiratory syncytial virus, adding an additional tool against the most common cause of hospitalization in infants.

The shot, called clesrovimab and given the brand name Enflonsia, is made by Merck and joins two other interventions already on the market to protect babies against severe disease from RSV, a common virus that can be especially dangerous for infants. One, like clesrovimab, is an antibody shot, and the other is a vaccine given during pregnancy.

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Data presented at the meeting showed that the approved interventions were safe and dramatically reduced hospitalizations among babies from RSV in the last respiratory virus season.

“As a pediatrician, I mean, people need to understand what a spectacular accomplishment these results are,” Meissner said at Wednesday’s ACIP meeting. They “will have an enormous influence on public health.”

The new drug was approved this month by the FDA, and the CDC committee’s recommendation was the next step in making it widely available for the coming RSV season, which typically begins in the fall.

As 100 Percent Fed Up highlighted earlier this month, the FDA approved Merck's RSV shot despite a disturbing serious adverse event rate in clinical trials.

FDA Approves RSV Shot For Infants – DISTURBING Serious Adverse Event Rate In Clinical Trials

“ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight,” Merck stated.

Children’s Health Defense warned the monoclonal antibody shot had a staggering 11.71% serious adverse event rate.

“These included febrile convulsions, seizures, facial paralysis and brain injury at about three times the rate in the vaccine group (25 of 2,409) as the placebo group (4 of 1,202),” Children’s Health Defense wrote.

Full text:

FDA Greenlights Merck’s RSV Shot for Newborns — Clinical Trials Showed 11.71% Rate of Serious Adverse Events, Including Death

The clinical trial results posted on the government website http://ClinicalTrials.gov included serious neurological adverse reactions that Dr. Peter Selley, a U.K. general practitioner who has closely followed the development of the drugs for RSV, called “concerning.”

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These included febrile convulsions, seizures, facial paralysis and brain injury at about three times the rate in the vaccine group (25 of 2,409) as the placebo group (4 of 1,202).

Children’s Health Defense Senior Research Scientist Karl Jablonowski said the trials showed a serious adverse event rate of 11.71% and included:

👉 A 50% greater chance of death (three deaths in the group that received the shot versus one in the placebo group).
👉 A 350% greater chance of an upper respiratory tract infection.
👉 A 63% greater chance of a lower respiratory tract infection.
👉 A 41% greater chance of febrile convulsion.

According to Children's Health Defense, several concerns about possible adverse event signals were raised during the ACIP meeting.

"Yesterday's vote on @Merck's new monoclonal antibody shot came after Retsef Levi, Ph.D. (@RetsefL) raised several concerns about possible adverse event signals from the drug’s clinical trials. In one trial, he said, there were five deaths in the vaccinated baby group and none in the placebo group. In another, when compared with an existing treatment, the death ratio was 5-to-1. In a third trial, it was 7-to-3," Children's Health Defense wrote.

"In one of the trials, immunized babies admitted to the hospital for RSV-related illness stayed longer than non-immunized babies with the same condition. Levi said this raises concerns that the immunization may have worsened their illness — a phenomenon called immunization-enhanced disease, which has complicated previous attempts to develop an RSV vaccine for infants," it continued.

"He said the trials and the adverse events were small, but 'should we perhaps be concerned?' Two of the seven committee members, Retsef Levi, Ph.D., and Vicky Pebsworth, Ph.D., opposed the recommendation, citing safety concerns. The remaining five members supported it," it added.

More from The Defender:

A Merck representative said investigators conducted an extensive analysis of the adverse events and determined none were related to the shot. She also noted that the FDA review was extensive and that the agency ultimately approved the shot.

Dr. Meryl Nass, who live-blogged the meeting for Children’s Health Defense (CHD) on CHD.TV, wrote, “I have to say this is what is always claimed by the manufacturer and the CDC, usually with no supportive information.”

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A researcher from the FDA acknowledged Levi’s point, saying “numerical numbers go in the wrong direction,” but the percentage differences were very small, between 0.2% and 0.3%, she said.

Co-chair Martin Kulldorff, Ph.D., said it would be critically important to monitor adverse events going forward.

New committee member Dr. H. Cody Meissner, who was part of the RSV work group, strongly supported the approval. He said the group had extensively discussed Levi’s concerns and was comfortable with the clinical trial results.

CHD Senior Research Scientist Karl Jablonowski told The Defender that despite Meissner’s assurances, the CDC working group noted that they “have serious concerns in the certainty assessment, specifically imprecision because ‘too few infants were included in the trial to capture rare events.’”

Jablonowski said that the trials showed clear risks and the drug “clearly needs a larger clinical trial to assess the risk to the most vulnerable. However, because the drug was approved, it won’t be a clinical trial of a few thousand that shows the risk; it will be population-wide surveillance.”

New committee member and ACIP co-chair Dr. Robert Malone also voiced strong support for the shots. Despite the short time frame, he said the group had conducted a rigorous analysis.

Levi, a father of six, said if he had a high-risk child, he would use the product to protect them. “On the other hand, if I was the father — and luckily I was the father — of a healthy child that was born on time, knowing all of this, I would be concerned to use it.”

After the vote to recommend Merck’s shot, all seven members then voted to add it to the Vaccines for Children Program, making it available for free to all infants whose families cannot afford it. The program serves more than 50% of U.S. children.


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