The Food and Drug Administration (FDA) is now reviewing Moderna's mRNA flu vaccine candidate, reversing an earlier rejection. The agency's initial decision to reject the application was reportedly met with internal scientific consensus to proceed with a review. However, a top official blocked the move.
Moderna's revised application proposes seeking full approval for individuals aged 50 to 64 and accelerated approval for those 65 and older. The latter pathway will require Moderna to conduct post-market trials to confirm effectiveness.
A spokesperson for the US Department of Health and Human Services confirmed the FDA accepted the amended application, emphasizing the agency's commitment to high standards. The situation highlights a broader concern within the industry regarding the perceived hostility towards mRNA technology by certain federal officials, which some argue is chilling vaccine research and investment.