May 21 (Reuters) – The U.S. FDA said on Thursday it would hold a meeting of outside experts next month to review Moderna’s experimental flu shot.
Moderna’s mRNA-based seasonal flu vaccine is currently under review by the U.S. Food and Drug Administration after the agency rejected the company’s initial application. A decision is expected by August 5.
In February, the agency fueled industry and investor concerns after it rejected Moderna’s application, citing concerns about the standard dose flu shot used in the comparison group.
After meeting with the company, the agency reversed course and accepted an amended application with the promise that Moderna would conduct an additional study in older adults once the vaccine is approved.
If approved, Moderna’s shot would be the first seasonal flu shot in the U.S. made with mRNA technology, a faster vaccine platform than conventional methods.
Health Secretary Robert F. Kennedy Jr., however, is a prominent critic of mRNA technology, which underpins Moderna’s and most other COVID-19 vaccines.
Moderna’s flu vaccine worked better than conventional flu shots in a late-stage international trial of more than 40,000 adults aged 50 and older, researchers reported earlier this month.
The advisory committee meeting is scheduled to be held on June 18, according to a federal register notice. The FDA’s Vaccines and Related Biological Products Advisory Committee advises the agency on whether to approve vaccines.
(Reporting by Sneha S K in Bengaluru; Editing by Tasim Zahid and Maju Samuel)
Comments