FDA Reverses Course on Moderna mRNA Flu Vaccine After Allegations
The U.S. Food and Drug Administration has agreed to review Moderna’s influenza vaccine application, reversing a prior rejection after the company made modifications. The revised approach seeks full approval for adults aged 50-64 and accelerated approval for those 65 and older, with a post-marketing study planned for older adults. This acceptance, which saw Moderna’s shares rise, follows a recent decision that had surprised the market and comes amidst evolving national health policy concerning mRNA technology. A decision on the vaccine candidate is anticipated by August 5.
John Q. Hosedrinker