FDA Refuses to Say When It Found Safety Signal for Seizures and COVID Vaccines in Children

Drug regulators in the United States are refusing to say when they first discovered a possible link between seizures and COVID-19 vaccines in children.

The FDA reported in a preprint paper on Oct. 15 that it detected a safety signal for seizures/convulsions in children aged 2 to 4 following Pfizer COVID-19 vaccination, and in children aged 2 to 5 following Moderna COVID-19 vaccination.
The paper reviewed safety monitoring data from no later than April 2023.

When asked when regulators first detected the signal, an FDA spokeswoman declined to say, continuing a pandemic pattern of withholding information about COVID-19 vaccines.

The corresponding author of the study, an FDA statistician, did not respond to a request for comment.

Drug safety advocates argued that the FDA should be more forthcoming, noting that convulsions are a known side effect of other shots, such as the measles and pertussis vaccines, and that they can cause brain inflammation.

“It’s critical that the FDA be completely transparent about the safety signal indicating an increased risk of seizures in young children following COVID-19 shots,” Barbara Loe Fisher, founder and co-president of the National Vaccine Information Center, told The Epoch Times via email.

“Unfortunately, public health officials have a history of being hesitant to acknowledge serious vaccine reactions like convulsions for fear of undermining public trust in vaccine safety.” However, the public is aware that not everyone reacts the same way to vaccination, and trust in public health policy recommendations is lost when health officials either refuse or are slow to make information available that can help people weigh the risks for themselves while taking into account their own current health and medical history,” she added.

Paper Information

Researchers from the FDA and three health care companies, including CVS Health, examined data from health claims databases and discovered a link between COVID-19 vaccination and seizures/convulsions in young children.
They identified 72 cases of seizures/convulsions in children within seven days of receiving a shot and compared rates to baseline rates from 2020.

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

They concluded that the signal “should be interpreted with caution and further investigated in a more robust epidemiological study,” in part because the signal disappeared when using background rates from 2022.

It is unclear whether the government intends to conduct an epidemiological study, and the FDA’s delay in reporting the signal means that other researchers have been unable to respond.

In response to a question about when the FDA discovered the signal and whether it looked for it in more recent versions of the shots, an FDA spokeswoman stated, “The FDA is confident in the safety, effectiveness, and quality of the COVID-19 vaccines.” These preprint paper reviews are part of our ongoing safety surveillance efforts, which use a variety of data sources. The data available continues to show that the benefits of these vaccines outweigh the risks.”

Pfizer and Moderna have yet to respond to inquiries.

The FDA has not issued an alert for the signal, as it did when it identified signals among the elderly in 2021 and again in 2023.
According to the most recent data available through September 29, 75 seizures and convulsions were reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination in children under the age of six.

The FDA and the Centers for Disease Control and Prevention (CDC) in the United States co-manage the system. According to studies, the reports need to be verified, but they frequently undercount the number of post-vaccination adverse events.

Ms. Fisher stated that the signal should be communicated to doctors and other vaccine providers. She believes that parents, particularly those with young children who have a history of seizures, should be informed as well.

Transparency Issues

The FDA and CDC have repeatedly kept information about COVID-19 vaccines, including signals, hidden.
The CDC, for example, did not inform the public that it discovered over 700 signals for the Pfizer and Moderna vaccines in May 2022, the first time it used a type of data mining known as proportional reporting ratio on reports to the Vaccine Adverse Event Reporting System. The records were obtained by the Epoch Times under the Freedom of Information Act.
In defending its non-disclosure, the CDC stated that the results were “generally consistent” with those obtained from FDA data mining.

The FDA has refused to release those findings, though they have been mentioned in some studies and presentations. The CDC has also stated that it has looked into some of the signals, confirming a few and ruling out others. It has not provided evidence that each signal was investigated.
The agencies have also refused to release documents from investigations into deaths after COVID-19 vaccination, as well as the results of studies Moderna conducted on post-vaccination subclinical heart inflammation.
When federal judges ordered it, the FDA began sharing documents it analyzed for its emergency authorization of the Pfizer and Moderna vaccines.