The following information is from Children’s Health Defense.

The FDA has approved Merck’s RSV antibody injection for newborns and infants, to be marketed under the name Enfanzia. The one-time shot, known scientifically as clesrovimab, is Merck’s direct competitor to Sanofi and AstraZeneca’s RSV shot, Beyfortus — which made $1.8 billion in its first year.

The approval positions Merck to claim a share of what analysts project to be a $13.59 billion global RSV market by 2030.

Merck says Enfanzia will reduce RSV-related hospitalizations by over 84% and medically attended cases by 60%. The company claims its safety profile is comparable to placebo.

But clinical trial data tell a different story.

According to records filed on ClinicalTrials.gov, infants who received Enfanzia experienced an 11.71% serious adverse event (SAE) rate — including a range of neurological issues such as seizures, febrile convulsions, facial paralysis, and brain injuries. These events were three times more frequent than in the placebo group.

There were also more deaths: three in the Enfanzia group, compared to one in the placebo group — a 50% increase. Additionally, babies who received the shot were more likely to suffer respiratory tract infections. Upper respiratory infections increased by 350%, and lower tract infections rose by 63%.

Dr. Karl Jablonowski, a biostatistician with Children’s Health Defense, questioned the FDA’s standards:

“If these are the standards for a successful FDA application, what does it take to fail?”

One major safety concern is the one-size-fits-all dose. Enfanzia uses a flat 105 mg dose regardless of the infant’s size. Dr. Peter Selley, a retired pediatrician, warned this could lead to dangerously high drug levels in very small or premature babies.

“Tiny preterm babies under 5 kilograms are going to be injected with a relatively much bigger dose… leading to massive levels of the drug in their circulation.”

RSV, or respiratory syncytial virus, infects nearly all babies by age two. While it is the leading cause of infant hospitalizations in the U.S., most cases are mild, and infant deaths remain rare — averaging about 25 per year.

Several pharmaceutical companies are now racing to dominate the infant RSV market. Pfizer’s Abrysvo, approved for use in pregnant women, was linked to increased risk of preterm birth. Beyfortus, a two-dose RSV shot, is already on the market. Synagis is reserved for high-risk infants only.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to vote on whether to recommend Enfanzia at its June 25–27 meeting. But the vote may now be uncertain: RFK Jr., in his role as HHS secretary, recently removed all 17 members of ACIP, citing systemic corruption and ties to the pharmaceutical industry.

For more information, read the full article here.