The Food and Drug Administration’s top vaccine official has overruled agency reviewers on three decisions involving COVID-19 vaccines, including the recent approval of Moderna’s shot to only some young children, according to documents released by the FDA.
Dr. Vinay Prasad, the agency’s chief medical officer and head of its Center for Biologics Evaluation and Research, said in a memorandum dated July 9 and made public by the FDA on July 11 that his analysis of Moderna’s Spikevax reached a conclusion different from that of agency reviewers.