The Food and Drug Administration has reversed its shocking decision to reject Moderna's mRNA flu vaccine application, agreeing to review the shot after a formal meeting with the company. The reversal comes after Vinay Prasad, the Trump administration's top vaccine regulator, initially overruled career scientists and rejected the application based on the control vaccine used in trials.

Moderna's vaccine, mRNA-1010, was tested in nearly 41,000 adults aged 50 and older using standard-dose influenza vaccines like Fluarix as comparators. The company has now proposed splitting the application, seeking full approval for ages 50-64 and accelerated approval for those 65 and up, which would require an additional effectiveness trial in older adults after market entry. The FDA expects to decide by August 5, 2026.

This reversal follows reporting that a team of career scientists was ready to review the vaccine and had presented their case to Prasad, who rejected it anyway. The decision aligns with Health Secretary Robert F. Kennedy Jr.'s broader anti-vaccine agenda, particularly his hostility toward mRNA technology. Moderna has already lost over $700 million in federal contracts for pandemic vaccines under the current administration.