Summary
The U.S. Food and Drug Administration (FDA) will now review Moderna's application for a new flu vaccine made with mRNA technology after initially refusing it. The vaccine showed better results in adults over 50 compared to a standard flu shot, but the FDA was concerned it did not include a comparison with a brand recommended for those over 65.
Key Facts
- The FDA is considering approval of Moderna's new mRNA flu vaccine.
- There was an earlier refusal to review the vaccine application.
- The vaccine uses mRNA technology, which has won a Nobel Prize.
- A clinical trial with 40,000 participants showed better effectiveness in people over age 50 compared to an existing flu shot.
- The FDA had concerns because the trial did not compare the vaccine to another brand recommended for those over 65.
- Dr. Vinay Prasad, the FDA's vaccine director, initially refused to review the application.
