FDA’s Vinay Prasad, in his own words

CBER Director Vinay Prasad announced radical changes to FDA’s regulatory framework for vaccines in a memo sent to FDA staff on Friday, Nov. 28.

As BioCentury has reported, the memo, which has not been publicly released, asserts that COVID vaccines were responsible for the deaths of at least 10 children. It cites this assertion to support decisions to stop allowing manufacturers to rely on immunogenicity surrogates and to require premarket randomized controlled trials for most vaccines. ...