Stephen Hoge
President of Moderna and vaccine executive responsible for development strategy and clinical programs, discussing the company's mRNA flu vaccine and regulatory interactions.
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Feb 12, 2026 • 51min
388: The FDA's refusal to review Moderna's mRNA flu vaccine
Jesse Goodman, former FDA official with deep regulatory experience, offers perspective on refuse-to-file norms. Lizzy Lawrence, STAT reporter, brings inside reporting on FDA vaccine office dynamics. Stephen Hoge, Moderna president, explains the company’s mRNA flu strategy and regulatory interactions. They discuss the FDA blocking review, trial design disagreements, comparators, and how agency decisions affect innovation and global strategy.
