Summary
The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday.
[...]
Moderna is now “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” the news release said.
“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said in a statement. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”