Moderna says FDA will now review its new flu vaccine, reversing earlier decision
CBSN
The U.S. Food and Drug Administration has reversed an earlier decision and said it will review drugmaker Moderna's application for approval of a seasonal flu vaccine, the company said in a statement Wednesday. Edited by Aimee Picchi In:
The U.S. Food and Drug Administration has reversed an earlier decision and said it will review drugmaker Moderna's application for approval of a seasonal flu vaccine, the company said in a statement Wednesday.
The FDA's Center for Biologics Evaluation and Research notified Moderna that the agency will allow the application for the vaccine candidate, mRNA-100, to proceed to review, the drugmaker said.
This marks a reversal for the FDA, which last week sent Moderna a so-called "refusal to file" letter rejecting the application. The dispute centered on a 40,000-person clinical trial that found Moderna's new vaccine was more effective in adults aged 50 and older than one of the standard flu shots used today.
The FDA, part of the U.S. Department of Health and Human Services (HHS), on Wednesday told CBS News that subsequent discussions with Moderna "led to a revised regulatory approach and an amended application, which FDA accepted."
"FDA will maintain its high standards during review and potential licensure stages as it does with all products," HHS spokesperson Andrew Nixon told CBS News.
