The Food and Drug Administration (FDA) approved Merck’s monoclonal antibody shot against respiratory syncytial virus (RSV) for infants up to one year of age.

“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

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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.”

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.

Merck’s shot will join Sanofi and AstraZeneca on the RSV market.

“PR Newswire projected that the global RSV vaccine and antibody market would reach $13.59 billion by 2030,” The Defender noted.

From The Defender:

Merck touts its shot as superior to Beyfortus because it can be given in a single dose, instead of a two-dose series. Enflonsia is given as a single 105 milligram (mg) dose for all babies. Beyfortus can be administered in doses of 50 or 100 mg, depending on the baby’s weight.

Clesrovimab “combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV,” Dr. Octavio Ramilo of St. Jude Children’s Research Hospital in Memphis, Tennessee, an investigator in two of the clinical trials, said in the press release.

However, Selley cautioned that “more is not better.” He told The Defender:

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“The implications of this are that with only one dose of clesrovimab, tiny preterm babies under 5 kilograms are going to be injected with a relatively much bigger dose of the monoclonal antibody, leading to massive levels of the drug in their circulation.

“In most other fields of medicine, the aim is to find the lowest dose of a drug that is effective, as most side effects are dose-related.”

Jablonowski pointed out that the FDA just approved MenQuadfi, a meningococcal conjugate vaccine with a serious adverse event rate of 5.19% that diminished the immune system and induced RSV infection at a rate 270% greater than the comparator (MENVEO) and febrile convulsions at a rate 426% greater.

“Then the FDA approves Enflonsia, with similar rates of adverse events. If these are the standards for a successful FDA application, what does it take to fail?”

“FDA just shamefully approved MenQuadfi to be injected into infants 6 weeks to 2 yrs old based on a trial that compared it to Menveo,” attorney Aaron Siri said.

“In the trial, 5.3% of infants receiving MenQuadfi and 3.6% of infants receiving Menveo had a serious adverse reaction (which means something very serious, see definition below). But because these rates were ‘similar,’ this product was deemed ‘safe’ by FDA because it assumes Menveo is ‘safe,’” he added.

Full text:

FDA just shamefully approved MenQuadfi to be injected into infants 6 weeks to 2 yrs old based on a trial that compared it to Menveo. In the trial, 5.3% of infants receiving MenQuadfi and 3.6% of infants receiving Menveo had a serious adverse reaction (which means something very serious, see definition below). But because these rates were “similar,” this product was deemed “safe” by FDA because it assumes Menveo is “safe.”

But Menveo was licensed based on a trial in which Menactra (among other vaccines) was used as a control; and Menactra was licensed based on a trial in which Menomune was used as a control; and Menomune was not licensed based on a proper placebo-controlled trial. In fact – and this is mind twisting – the package insert for Menomune lists the clinical trial for Menactra (in which Menomume was used as the control) as the basis for its safety. I couldn’t even dream of making this stuff up.

This provides a good example of the vaccine safety pyramid scheme: Menomune was licensed without a proper placebo-controlled trial and was then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi. And then we get a trial with 5.3 % and 3.5% of infants suffering serious adverse reactions and no one bats an eye. They grant licensure.

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A pyramid scheme of safety, at the bottom of which there is no baseline on which safety is being judged. Just a get-it-licensed-to-profit shell game. FDA and pharma have nothing to lose here. We, as taxpayers, will pay for all of the harms suffered and, worst of all, the children who are injected and harmed and their families will really pay for the harms.

Per Reuters:

The U.S. saw limited supply of antibody Beyfortus up to the 2023 RSV season, but the companies have since tripled production capacity and doubled the number of manufacturing sites.

A Sanofi spokesperson said “current supply … matches the total amount distributed during the entire last season … We are continuing to manufacture more doses, which will result in a larger overall supply than was available last year.”

In the U.S., an estimated 58,000–80,000 children younger than five years are hospitalized due to RSV each year, according to the U.S. Centers for Disease Control and Prevention.

The CDC currently recommends two immunization options for babies to be protected from severe RSV — an RSV vaccine given to the mother during pregnancy or an RSV antibody given to the baby.

Merck expects the drug’s shipments to arrive in time for the 2025-2026 RSV season.

Merck had earlier on Monday said the CDC’s Advisory Committee on Immunization Practices was expected to meet later this month to discuss and make recommendations for the use of Enflonsia in infants. However, Health Secretary Robert F. Kennedy Jr. has fired all members sitting on the CDC panel.

 

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