FDA detects seizure risk in mRNA vaxxed toddlers, yet maintains technology still ‘favourable for use’

The US Food and Drug Administration (FDA) has detected a safety signal for seizures in children ages two to four following mRNA COVID-19 vaccination. Despite findings, government officials continue to recommends the shots for young children.The FDA study includes only “monovalent” vaccines. The adverse effects of subsequent boosters were not evaluated. Researchers found in most cases, the seizures occurred within three days of mRNA inoculation. The majority of those children suffered a febrile seizure, which occurs when the young child has a fever above 100.4°F, per Kids Health. The World Health Organization (WHO) defines a vaccine safety signal as information that indicates a potential causal link between a vaccine and an adverse event that could affect health, where further research is needed to confirm the link. The study, published Wednesday in peer-reviewed medical publication JAMA Network Open, examines the “safety” of several strands of COVID-19 mRNA vaccines in US children aged six-months to 17 years old.Data on more than four million children was analyzed from three major claims databases provided by Optum, Carelon Research, and CVS Health, which contribute to the FDA’s Biologics Effectiveness and Safety System — a system that monitors the emergence of safety signals after vaccination, according to Children’s Health Defense. The same safety signal was found in all three databases.State and regional vaccination information systems were also analyzed and included in the study. .FDA officials identified and researched 21 adverse health outcomes following the mRNA jab in 4,102,016 children six-months to 17 years old prior to early 2023. These include Guillain-Barré syndrome, encephalitis, seizures, myocarditis and pericarditis. Researchers then selected 15 conditions with the most historical data related to inoculation and compared the 2023 data to outcomes from other vaccines in 2019, 2020 or both. Overall, 72 cases of seizures among two- to four-year-old children, or five years old (for the Moderna vaccine). Using “near-real-time monitoring,” health officials detected “a new statistical signal for seizure” in children ages two to four who received the original Pfizer vaccine and children ages two to five who received the original Moderna vaccine, the report states. A previously identified safety signal for myocarditis or pericarditis following the Pfizer vaccine in youth ages 12 to 17 was reinforced through the same study. .The FDA report follows a preliminary study published March 12, which specifically evaluated “febrile seizure risk” following the vaccination among US children aged two to five years old.Researchers, who analyzed the same data as the JAMA study, found COVID-19 mRNA-vaccinated young children from two to five years of age were 2.5 times more likely to have a febrile seizure within one day of inoculation than between eight and 63 days following vaccination.Authors also found a higher risk of febrile seizures among two- to four-year-olds one day after the Pfizer vaccine than in the 8 to 63 days following vaccination, but said the increased risk was not statistically significant. .In the same fashion, a government-funded study from National Academies released earlier in April reported a causal link between mRNA COVID-19 vaccines and myocarditis but rejected a causal link between the mRNA jabs and a laundry list of other potential adverse effects. Researchers said they had reviewed numerous studies on COVID-19 vaccination adverse events in minors under 18, but did not find sufficient evidence to make definitive conclusions. The JAMA study findings are consistent with the Vaccine Adverse Event Reporting System (VAERS) database, where eight seizures were identified after approximately one million mRNA shots through August 2022 in children ages six-months to five-years-old. However, of the eight per million VAERS reports, only two were reportedly febrile. Pfizer’s own clinical trials demonstrated five cases of seizures among vaccinated young children — but claims only one of those cases was considered “possibly related to the vaccine,” per Children’s Health Defense. Strengths of the JAMA study included the large and geographically diverse population covered by the databases, the study authors said. Limitations included a lack of control for confounding variables.Despite the safety signals, FDA researchers maintain vaccinating young children with the COVID-19 mRNA shots is still favourable to not doing so. “The new statistical signal for seizure observed in our study should be interpreted with caution and further investigated in a more robust epidemiologic study,” wrote researchers, asserting the febrile seizures found in young children may not be related to vaccination. Researchers also noted the safety signal either changed or disappeared when they used data from earlier years as a test group.“The FDA concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection,” wrote FDA officials. Prior to the FDA study, the US Centers for Disease Control and Prevention (CDC) published an April 19 report disclosing the mRNA vaccines don’t provide long-term protection from COVID-19, plummeting from 52% effectiveness against hospitalization to 19% after only four months. Likewise, protection against “critical illness” dropped from 57% to 25% in the same time frame. Yet, like the FDA, CDC officials still recommended children should get mRNA boosters and remain up-to-date with all COVIS-19 shots. Researchers only analyzed monovalent COVID-19 vaccines (not including boosters) administered December 19, 2021 through October 29, 2023.The CDC said not enough children and teens got the booster to do a comprehensive separate study. Ethical questions were raised surrounding the CDC study, because several researchers admitted to either receiving funding or holding Pfizer stocks, and one reported funding from Moderna, according to Children’s Health Defense.CDC recommendations still include boosters for babies six-months and older.