A preprint study by the U.S. Food and Drug Administration (FDA) posted October 15 found a safety ‘signal’ of seizures/convulsions for young children who received an mRNA COVID-19 injection.

The agency detected the signal for seizures/convulsions for children aged 2-4 who received the Pfizer COVID-19 shot and children aged 2-5 who received the Moderna COVID-19 shot.

“In this study including 4,102,106 vaccinated enrollees from three commercial claims databases, myocarditis or pericarditis signaled after BNT162b2 (12-17 years) and a new signal was detected for seizures/convulsions after BNT162b2 (2-4 years) and mRNA1273 COVID-19 vaccinations (2-5 years),” the preprint read.

“In the primary analysis, seizures/convulsions met the statistical threshold for a signal in children aged 2-4 years following BNT162b2 vaccination in all three databases, and in children aged 2-5 years following mRNA-1273 vaccination in two of the three databases. Dose-specific signals for seizures/convulsions were detected in two of the three databases following dose 1 and dose 2 BNT162b2 vaccination in ages 2-4 years and following dose 2 mRNA-1273 vaccination in ages 2-5 years,” the preprint stated.

“There were 72 observed seizures/convulsions cases among children aged 2-4/5 years and >50% of these cases met the definition of febrile seizures. No differences in rates of seizures/convulsions by sex were identified. The timing of cases did not indicate substantial clustering with cases distributed across the 0-7-day risk window; 31.9% of the seizures/convulsions cases occurred within the 0-1 days following COVID-19 vaccination. The median time between vaccination and diagnosis of seizures/convulsions was 2 days,” the preprint read.

“The seizures/convulsions signal in children aged 2-4/5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines. However, there are reports from the Vaccine Adverse Events Reporting System (VAERS) database which is a passive reporting system and has limitations. In an analysis of VAERS data, only 8 seizures were identified following approximately one million mRNA vaccinations through August 2022 in the age group 6 months to 5 years. Six of the 8 seizures were afebrile on medical evaluation,” it added.

“A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link,” The Epoch Times noted.

Per The Epoch Times:

The data came from three health claims databases run by Optum, Carelon Research, and CVS Health, supplemented with vaccination information from state and local systems. The health claims databases are part of the FDA’s Biologics Effectiveness and Safety System, a drug safety monitoring system.

Researchers looked at 15 health conditions following vaccination entered in the commercial databases and compared rates among children aged 6 months old to 17 years old to background rates from 2019, 2020, or both.

Overall, 72 cases of seizures/convulsions were recorded within seven days of a shot among toddlers and other young children. Most happened within three days of a shot.

When stratifying the data by dose, the researchers found signals for dose one and dose two for Pfizer’s shot in two of the three databases in children aged 2 to 4. They also found a signal following dose two of Moderna’s shot in children aged two to five.

The signal for seizures/convulsions for the young children “has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines,” the researchers said, referring to the Pfizer and Moderna shots.

“Our study detected a signal for myocarditis/pericarditis in older children which is consistent with existing literature, and a new signal for seizures/convulsions in young children that is being further evaluated in a more robust study,” the preprint concluded.

However, the agency had the same Pharma-shielding analysis.

“FDA concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection. This study was conducted under the FDA BEST Initiative which plays a major role in the larger US federal government vaccine safety monitoring efforts and further supports regulatory decision-making regarding COVID-19 vaccines,” the preprint stated.

Read the full preprint HERE.

 

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