Summary
The FDA will review Moderna's flu vaccine application after initially declining to do so. Moderna wants approval for a flu shot for people aged 50 and over. The review process should finish by August 5.
Key Facts
- The FDA agreed to review Moderna's flu vaccine application after initially refusing.
- Moderna's flu vaccine is intended for people aged 50 and older, with expedited approval sought for those over 65.
- The FDA initially refused the application because it lacked a comparison with a high-dose vaccine in the trial.
- Moderna had already conducted a 40,000-person trial showing the vaccine's effectiveness.
- The flu vaccine uses mRNA technology, which has been criticized by Health and Human Services Secretary Robert F Kennedy Jr.
- The FDA plans to decide on the revised application by August 5.
- The refusal and subsequent acceptance of the vaccine application raised concerns about regulatory consistency and vaccine policies under President Donald Trump's administration.
- Moderna's CEO expressed gratitude for the FDA’s willingness to reconsider the application.
