The U.S. FDA will hold an expert committee meeting in June to review Moderna's experimental flu shot.
Moderna's mRNA-based seasonal flu vaccine is under review after the agency initially rejected its application. A decision is expected by August 5.
In February, the FDA rejected Moderna's application over concerns about the standard dose comparator. After discussions, the agency accepted an amended application with a pledge for an additional study in older adults.
If approved, it would be the first seasonal flu shot in the U.S. using mRNA technology.
Health Secretary Robert F. Kennedy Jr. is a prominent critic of mRNA technology.
Moderna's vaccine outperformed conventional shots in a late-stage trial of over 40,000 adults aged 50 and older.
The advisory committee meeting is scheduled for June 18.
