(The Epoch Times)—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 zero to one day after a Moderna shot, compared to 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, compared to the same 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 febrile 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 jab. 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 utilized in the new study ensures 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.
Coffee the Christian way: Promised Grounds
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.”
Independent Journalism Is Dying
Ever since President Trump’s miraculous victory, we’ve heard an incessant drumbeat about how legacy media is dying. This is true. The people have awakened to the reality that they’re being lied to by the self-proclaimed “Arbiters of Truth” for the sake of political expediency, corporate self-protection, and globalist ambitions.
But even as independent journalism rises to fill the void left by legacy media, there is still a huge challenge. Those at the top of independent media like Joe Rogan, Dan Bongino, and Tucker Carlson are thriving and rightly so. They have earned their audience and the financial rewards that come from it. They’ve taken risks and worked hard to get to where they are.
For “the rest of us,” legacy media and their proxies are making it exceptionally difficult to survive, let alone thrive. They still have a stranglehold over the “fact checkers” who have a dramatic impact on readership and viewership. YouTube, Facebook, and Google still stifle us. The freer speech platforms like Rumble and 𝕏 can only reward so many of their popular content creators. For independent journalists on the outside looking in, our only recourse is to rely on affiliates and sponsors.
But even as it seems nearly impossible to make a living, there are blessings that should not be disregarded. By highlighting strong sponsors who share our America First worldview, we have been able to make lifelong connections and even a bit of revenue to help us along. This is why we enjoy symbiotic relationships with companies like MyPillow, Jase Medical, and Promised Grounds. We help them with our recommendations and they reward us with money when our audience buys from them.
The same can be said about our preparedness sponsor, Prepper All-Naturals. Their long-term storage beef has a 25-year shelf life and is made with one ingredient: All-American Beef.
Even our faith-driven precious metals sponsor helps us tremendously while also helping Americans protect their life’s savings. We are blessed to work with them.
Independent media is the future. In many ways, that future is already here. While the phrase, “the more the merrier,” does not apply to this business because there are still some bad actors in the independent media field, there are many great ones that do not get nearly enough attention. We hope to change that one content creator at a time.
Thank you and God Bless,
JD Rucker
