# Stephen Hoge

Type: Person

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/stephen-hoge
Canonical HTML page: https://getbiobrief.com/entity/stephen-hoge

## Timeline

- **2026-08-05**: FDA Decision Deadline — The agency faces a deadline to approve or reject the vaccine.
- **2026-06**: Advisory Panel Recommends Approval — An FDA advisory panel votes in favor of approving the vaccine.
- **2026-02**: FDA Issues Refuse-to-File Letter — FDA informs Moderna it will not review the mRNA flu shot application, surprising the company after prior assurances.
- **2026-02**: FDA Accepts Application After Outcry — A little over a week later, the agency reverses its decision after Moderna commits to a confirmatory study.

## Recent coverage (1 stories)

### Moderna's mRNA Flu Shot: FDA Decision by Aug 5 Could End 6-Month Regulatory Ordeal
2026-08-01 15:39:40 · Sentiment: Neutral · Impact: 6/10 · Sources: 6

After a shocking FDA refusal-to-file in February and a subsequent advisory panel endorsement, Moderna's experimental mRNA influenza vaccine faces a final decision on August 5. The outcome holds deep implications for the viability of mRNA technology beyond COVID-19 and the future of Moderna's pipeline diversification.
Full story: https://getbiobrief.com/story/moderna-mrna-flu-shot-fda-decision-aug-5

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