FDA Withholds Information on Safety Signal for Seizures and COVID Vaccines in Children
U.S. drug regulators have come under scrutiny for their handling of information regarding a potential link between seizures and COVID-19 vaccines in children.
On October 15, the U.S. Food and Drug Administration (FDA) released a preprint paper revealing a safety signal for seizures or convulsions in children aged 2 to 4 after receiving the Pfizer COVID-19 vaccine, and in children aged 2 to 5 after receiving the Moderna COVID-19 vaccine. This analysis was based on data up to April 2023.
Despite this revelation, the FDA has refrained from disclosing when they initially identified this signal. This lack of transparency has raised concerns among drug safety advocates. Convulsions are recognized complications of other vaccines, like those for measles and pertussis, which can lead to brain inflammation.
Barbara Loe Fisher, founder and co-president of the National Vaccine Information Center, emphasized the importance of the FDA being forthright about this potential risk, noting that trust in public health policies can be eroded when information is withheld.
The study, conducted by researchers from the FDA and three healthcare companies, including CVS Health, examined health claims databases and identified 72 cases of seizures or convulsions within seven days of vaccination in young children.
They compared these rates with background rates from 2020, highlighting that this signal had not been previously reported for this age group in studies of mRNA COVID-19 vaccines. However, they also cautioned that further investigation in a more comprehensive epidemiological study was warranted.
Notably, when using background rates from 2022, the signal diminished, adding complexity to the interpretation. Unfortunately, it remains unclear if the government intends to conduct such an epidemiological study, and the delay in reporting by the FDA has hindered other researchers from taking action.
The FDA’s response to inquiries about the signal focused on reaffirming confidence in the safety, effectiveness, and quality of COVID-19 vaccines, without directly addressing when the signal was initially identified or if it was investigated with more recent vaccine versions. Both Pfizer and Moderna have not issued comments regarding this development.
In contrast to previous instances where the FDA promptly issued alerts for signals among older populations, no alert has been issued for this signal involving young children. As of September 29, the Vaccine Adverse Event Reporting System (co-managed by the FDA and the U.S. Centers for Disease Control and Prevention) recorded 75 instances of seizures and convulsions following COVID-19 vaccination in children under 6. It’s worth noting that these reports may not capture the full scope of post-vaccination adverse events.
Barbara Loe Fisher emphasized the importance of informing doctors, vaccine providers, and parents, especially those with young children prone to seizures, about this signal. This episode underscores ongoing transparency issues with the FDA and CDC regarding COVID-19 vaccines. The CDC, for instance, did not publicly disclose over 700 signals for Pfizer and Moderna vaccines in May 2022.
The FDA has also declined to release certain results and documents related to investigations into post-vaccination events, only doing so under court order. These instances of non-disclosure have raised concerns about the agencies’ commitment to transparency and public trust.
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