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FDA reverses course on Moderna’s flu vaccine
The Food and Drug Administration has reversed its prior decision and will review Moderna’s experimental flu vaccine application for potential approval under a revised regulatory approach. Last week, the FDA rejected the company’s application, citing issues wit
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The Food and Drug Administration has reversed its prior decision and will review Moderna’s experimental flu vaccine application for potential approval under a revised regulatory approach. Last week, the FDA rejected the company’s application, citing issues with the comparator chosen in clinical testing. Moderna said Wednesday that, following a so-called Type A meeting, the agency agreed to review the approval application for mRNA-1010, with a deadline of Aug. 5. Moderna hopes to secure an FDA nod based on age. It’s seeking traditional approval for adults aged 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it agreed to conduct a post-marketing study in older adults. If approved, the shot could be available to that population for the 2026-27 flu season. "We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," said Stéphane Bancel, CEO of Moderna. Vaccine makers have faced an uncertain market under the leadership of Robert F. Kennedy Jr., a vaccine skeptic who has heavily questioned the safety and efficacy of several shots. Moderna has been especially hit. Reeling from lowered sales of its COVID-19 vaccine, the company has been heavily scrutinized for its use of messenger RNA technology. Under Kennedy’s leadership, the Health and Human Services Department canceled millions of dollars in government contracts for mRNA vaccine research. Meanwhile, the FDA set stricter approval standards for COVID shots and issued narrow approvals, while the Centers for Disease Control and Prevention softened recommendations for the vaccines. As a result of the challenging climate, Moderna said it would no longer invest in late-stage trials for vaccines and is shifting its focus to oncology. Last week, in an unorthodox move, the company publicly shared the “refusal-to-file” letter that rejected its application. The FDA’s top vaccine official, Vinay Prasad, signed the letter and stated Moderna’s Phase 3 trial testing mRNA-1010 was not “adequate and well-controlled.” Moderna immediately requested a meeting to discuss the candidate’s future. The move sparked backlash from the industry, as reports said Prasad overruled agency reviewers in rejecting the application. In a Wednesday note to clients, TD Cowen analyst Tyler Van Buren wrote that he believes this backlash led the agency to “quickly find an acceptable solution.” He highlighted the “remarkably short turnaround for a Type A meeting,” which typically doesn’t happen for 30 to 60 days after a refuse to file letter is received. Some analysts are still skeptical of the move. Mani Foroohar, in his own note, argued the FDA reversal is a “meaningful positive ... though uncertainty remains.” “It remains to be seen how this more assertive approach to the FDA ultimately impacts the review outcome for mRNA-1010, details of a post-marketing study, and — most financially important for Moderna — approval path for the combo flu/COVID vaccine,” Foroohar added. In an email to BioPharma Dive, HHS Spokesman Andrew Nixon said the “FDA will maintain its high standards during review and potential licensure stages as it does with all products.” Shares for Moderna were up more than 8% at certain points Wednesday morning. Editor's Note: This story has been updated to include a statement from HHS.