The U.S. Food and Drug Administration (FDA) has agreed to review Moderna's new mRNA-based influenza vaccine, reversing an earlier decision to reject the application.
Moderna announced the FDA's decision follows a constructive meeting, with the review proceeding under a pathway focused on older adults. The company is seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. An additional post-market study has also been agreed upon.
The FDA's initial rejection cited an inadequate clinical trial. This development occurs amidst calls for a reconsideration of vaccine approval procedures, including for influenza, with proposed federal policy changes raising concerns among public health professionals.
Moderna's new shot utilizes mRNA technology, which has seen varied stances from administration officials. The vaccine has already received acceptance for review in the European Union, Canada, and Australia.
Moderna CEO Stephane Bancel expressed appreciation for the FDA's engagement, stating the company looks forward to making the flu vaccine available to American seniors.