Toddlers and young children are at risk of suffering from deadly
seizures shortly after COVID-19 vaccination, according to an urgent
warning issued by the U.S. Food and Drug Administration (FDA).
The occurrence of febrile seizures was 2.5 times higher among children
within 24 hours of receiving a Moderna shot than among the same children
eight to 63 days after vaccination, researchers at the FDA warned.
Theepochtimes.com reports: 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.
In a secondary analysis, using a longer risk interval within seven
days of vaccination, researchers identified 103 febrile seizures and 135
seizures/convulsions after Pfizer vaccination, including 22 febrile
seizures and 32 seizures/convulsions within seven days of a shot. The
secondary analysis showed 78 febrile seizures and 106
seizures/convulsions after Moderna vaccination, including 21 febrile
seizures and 28 seizures/convulsions in the longer risk interval.
No statistically significant findings showed up for that secondary
analysis, or any other secondary analyses, after researchers applied
adjustments to the data.
Exclusions included children who received more doses than approved.
Researchers analyzed data from the Carelon database from June 2022 to
February 2023, from June 2022 to March 2023 from the CVS database, and
from June 2022 to May 2023 in the Optum database.
The FDA authorized new versions of vaccines from Pfizer, Moderna, and
Novavax in late 2023, relying on clinical trial data from just 50
humans. Those currently available versions are not covered by the
research.
The FDA funded the new study. Limitations of the research included the small number of cases, according to the researchers.
Dr. Harvey Risch, professor emeritus of epidemiology at the Yale
School of Public Health, who was not involved in the research, agreed.
“These small numbers are not large enough for a reliable statistical
analysis, which makes the paper scientifically weak,” Dr. Risch told The
Epoch Times in an email.
The corresponding author, Mr. Forshee, did not respond to a request
for comment. The FDA declined to comment. Moderna and Pfizer did not
return inquiries.
Despite the finding of elevated risk, the researchers claimed that
“based on the current body of scientific evidence, the safety profile of
the monovalent mRNA vaccines remains favorable for use in young
children.”
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Author: Planet Today
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