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FDA Admits COVID Vaccines Cause Seizures in Toddlers

The risk was “significantly elevated,” FDA researchers wrote in a new preprint paper.



This article originally appeared on The Epoch Times and was republished with permission.

Guest post by Zachary Stieber

Toddlers and other young children faced a higher risk of seizures shortly after COVID-19 vaccination, according to a new study from U.S. Food and Drug Administration (FDA) researchers.

The incidence of febrile seizures was 2.5 times higher among children within a day after receiving a Moderna shot than among the same children eight to 63 days after vaccination, the researchers said.

That risk was “significantly elevated,” they wrote in a preprint paper describing the results.

There was also a higher risk for febrile seizures zero to one day after receipt of a Pfizer-BioNTech dose than in the 8–63 day window following vaccination, but that elevated risk was not statistically significant.

Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, and other researchers conducted the self-controlled case series by analyzing data from commercial databases. The data came from CVS Health, Optum, and Carelon Research. The children were 2 to 5 years old.

Fever is a common side effect of the COVID-19 vaccines. Some 19 percent of children aged 2 to 3, for instance, in Pfizer’s clinical trial suffered fever after a second dose. Fever may result in some cases in seizures, health officials said.

The study was carried out after the researchers identified seizures/convulsions as a safety signal among children aged 2 to 4 following receipt of Pfizer’s shot and among children aged 2 to 5 after a Moderna shot. Further research was needed because the method of identification, near real-time surveillance, “was designed to be sensitive but not specific for screening and detection purposes,” the researchers said. Febrile seizures became the focus because most of the cases identified in the prior study were seizures of that type.

The two-day window used in the new study ensures that the seizure cases “are more likely to be associated with vaccination rather than other causes,” the researchers said.

There were 88 febrile seizures after the Pfizer vaccination among the study population. Seven of those cases happened the day of or the day after vaccination.

There were 67 cases after the Moderna vaccination. Ten happened in the two-day window.

Seizures that happened two to seven days after vaccination were excluded from the primary analysis.

Read the full story in The Epoch Times.

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