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The decision by the FDA on Wednesday to reverse course and review Moderna’s flu vaccine application was the result of a meeting Tuesday between an unusual group of senior FDA leaders and Moderna, with the FDA leaders walking back their boss’ overruling, according to two sources familiar with the meeting.
The reversal was not based on previous data or the new submission, according to an FDA senior leader with direct knowledge of Moderna’s application. In the meeting, three senior leaders in the agency’s Office of Vaccines Research and Review, including the office director David Kaslow, walked back their refuse-to-file (RTF) letter sent last week. CBER Director Vinay Prasad had overruled Kaslow and review staff in making the decision to issue the letter.