FDA Refuses to Say Whether It Will Add Seizures to COVID-19 Vaccine Labels

The U.S. Food and Drug Administration (FDA) is refusing to say whether it will add the possible side effect of seizures to labels for the two most widely used COVID-19 vaccines, after researchers with the agency detected a safety signal for seizures following Moderna and Pfizer-BioNTech COVID-19 vaccination.

In a preprint paper published in late 2023, researchers with the FDA said that seizures and convulsions among children aged 2 to 5 after COVID-19 vaccination set off a safety signal in health care databases. A peer-reviewed version of the paper was published on April 24.

Another recent paper from FDA scientists, published in March, found that young children faced a higher risk of seizures shortly after receipt of the Moderna or Pfizer shots.

The Epoch Times on April 29 asked the FDA whether the agency would be updating labels for the vaccines to reflect the safety signal finding, as the labels for the vaccines currently do not list seizures as a possible side effect.

An FDA spokesperson on Monday acknowledged receipt of the query and promised to “be back in touch shortly.” But neither the spokesperson nor any other FDA officials answered questions prior to the deadline they were given, which was over 36 hours after the query was received.

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