STAT NEWS – The Food and Drug Administration’s top vaccine regulator asserted in an email to staff sent Friday that the Covid-19 vaccine caused at least 10 deaths in children and called for changes to the way the agency regulates vaccines.
But experts told STAT they are skeptical of the memo’s “extraordinary” claim because it was not presented with detailed data.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in the email that regulatory requirements for new vaccines would be heightened as a result of the deaths.
“This is a profound revelation,” Prasad wrote in the memo, which was obtained by STAT and has since been made available online by other news organizations. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
“Outside experts said they would need much more evidence to understand whether it had been established that the Covid vaccine caused deaths in children. They said it was surprising that more data were not included in the memo … “
“In many cases, such mandates were harmful,” Prasad wrote. “It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”
Prasad and representatives of the the Department of Health and Human Services, which oversees the FDA, did not respond to a detailed request for comment.
It is unclear what the FDA’s next steps will be. The memo does not contain any information on plans to release more detailed information on the deaths or to publish the result in a medical journal.
Prasad said the agency would require more definitive data for vaccines administered during pregnancy and that he plans to reform the way that annual influenza vaccines are regulated.
He also stated that the FDA may look at whether multiple shots should be given at once, a concern that could disrupt the childhood vaccine schedule.
“The talk about purported danger of combined vaccines or multiple vaccines given at same visit is concerning” …
