FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

The outcome today is in stark contrast to a few months ago, when Trump official Vinay Prasad was overseeing vaccines at the FDA. In a shocking decision in February, Prasad rejected Moderna’s filing, refusing to even review the vaccine. Prasad claimed that the large vaccine trial was not “adequate and well-controlled” because it did not compare efficacy to a high-dose vaccine in people 65 and older. Instead, Moderna used the smaller trial to compare immune responses of mRNA-1010 to a high-dose vaccine—which was a plan the FDA had previously agreed would be acceptable.

Moderna was blindsided by the refusal, which Prasad issued over the objections of FDA scientists and career officials. Amid widespread outcry, the FDA reversed the decision the next week, agreeing to review the vaccine. Around the same time, Prasad was also behind the rejection of a closely watched gene therapy for Huntington’s disease made by UniQure, which was widely criticized and called “truly evil” by a former FDA official.

Prasad was pushed out of FDA at the end of April amid a string of decried decisions and controversies. Prasad’s decision on UniQure’s gene therapy was reversed on Wednesday.