by Brenda Baletti, Ph.D., Childrens Health Defense:
According to FDA researchers, the higher rate of febrile seizures from the mRNA COVID-19 vaccines “is not large compared to some other vaccines and combinations of vaccines” that can cause seizures at higher rates.
Children ages 2-5 who received the COVID-19 mRNA vaccine faced an increased risk of febrile seizures immediately following vaccination, according to a new study led by researchers at the U.S. Food and Drug Administration (FDA).
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The preprint study found children who received the Moderna shot were 2.5 times more likely to have a febrile seizure within a day of being vaccinated than they were to have one between eight and 63 days following vaccination.
The incidence rate ratio was “significantly elevated,” the researchers wrote, but the “absolute risk” — the risk of having a seizure following vaccination, was low within the first day following vaccination.
FDA researchers also found a higher risk of febrile seizures among children ages 2-4 on the first day following the Pfizer vaccine than in the 8-63 days following vaccination. However, that increased risk was not statistically significant, the researchers reported.
“Based on the current body of scientific evidence, the safety profile of the monovalent mRNA vaccines remains favorable for use in young children,” the researchers concluded.
Dr. Michelle Perro, a pediatrician and co-author of “What’s Making our Children Sick?” told The Defender that the way the authors mixed different measures of risk in their reporting obfuscated the findings.
“This paper buried itself in statistical gymnastics and made it difficult to assess their true findings,” despite their claim that the safety profile remains favorable, Perro said.
“Based on their own data, I would advise that this vaccination is risky due to the probability of the occurrence of non-febrile seizures in a small population of vaccinated children, along with the fact that we don’t know what other future effects might be,” Perro said.
The FDA’s Richard A. Forshee, Ph.D., led the team of researchers who came largely from commercial health claim database companies — Carelon Research, CVS Health and Optum — that contributed data to the analysis.
Safety signal led to study
After the FDA authorized Pfizer and Moderna’s COVID-19 vaccines in June 2022 for emergency use in children ages 6 months and older, the agency’s Center for Biologics and Evaluation Research conducted the mandatory near-real-time safety monitoring.
The agency detected a signal for seizures/convulsions after both one and two doses of the vaccines among children ages 2-5 who received the Moderna vaccine and children ages 2-4 who received the Pfizer vaccine.
Further evaluation of the signal was necessary, the researchers wrote, because the agency’s surveillance was “designed to be sensitive but not specific for screening and detection purposes.”
The FDA had monitored seizures/convulsions for seven days following vaccination and found that febrile seizures were the most common event, so they made those the primary object of analysis.
Forshee and his team analyzed data on COVID-19 vaccination and medical claims regarding seizures among children ages 2-5 from several medical claims databases.
The study excluded children who had received more than the recommended number of vaccine doses. All study periods began when the vaccines were authorized for children in June 17, 2022.
The data from the Carelon database extended through Feb. 4, 2023. The CVS database extended through March 26, 2023, and the Optum database extended through May 20, 2023.
The research examined only the original emergency use authorized monovalent vaccines.
The CDC now recommends that children ages 6 months to 4 years get two to three doses of the updated Moderna or Pfizer vaccines and children ages 5 and up get one dose.
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