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.
