FDA Reverses Refusal, Will Review Moderna mRNA Flu Vaccine
FDA agreed to review Moderna’s mRNA flu vaccine after a Type A meeting and an amended application that seeks full approval for adults 50–64 and accelerated approval for 65+. Agency aims decision by Aug. 5, 2026.
Overview
The FDA reversed a prior "refusal to file" and agreed to accept Moderna's amended application to review its mRNA flu vaccine, mRNA-100/mRNA-1010, after a Type A meeting, the company said.
The initial refusal centered on the Phase 3 trial's use of standard-dose licensed flu vaccines as comparators, which the FDA vaccine director said did not reflect the best-available standard of care for people 65 and older.
Moderna proposed seeking full approval for adults 50 to 64 and accelerated approval for adults 65 and older with an additional post-market study, and the FDA accepted the revised regulatory approach.
Moderna's pivotal trial involved roughly 40,000 adults aged 50 and older and found the mRNA vaccine was more effective than a standard-dose licensed shot in the study, company statements said.
The FDA is expected to provide a decision on the application by Aug. 5, 2026, and Moderna said it aims to make the vaccine available later this year pending approval.
Analysis
Center-leaning sources frame the story as a dispute highlighting FDA politicization and increased scrutiny of mRNA vaccines, emphasizing Moderna's objections and procedural oddities. They stress unusualness ('refusal to file', 'public dispute') and regulatory shifts under Health Secretary Robert F. Kennedy Jr., prioritizing context that casts the FDA's actions as controversial.
Sources (11)
FAQ
Accelerated approval is a regulatory pathway that allows the FDA to approve medications based on surrogate endpoints or preliminary evidence of effectiveness, rather than waiting for complete long-term data[1]. The FDA agreed to use this pathway for adults 65 and older because Moderna proposed conducting an additional post-marketing study in this population to gather more comprehensive data, allowing the vaccine to potentially reach the market sooner while still gathering required evidence.
The FDA initially refused to review the application because Moderna's pivotal trial used a standard-dose licensed influenza vaccine as the comparator, which the FDA said did not reflect the best-available standard of care for older adults[7][8]. The FDA had previously recommended in 2024 that Moderna use a comparator high-dose vaccine preferentially recommended for older adults by the CDC's Advisory Committee on Immunization Practices[6].
Moderna's pivotal trial involved approximately 40,000 adults aged 50 and older and found that the mRNA vaccine was more effective than a standard-dose licensed flu shot in the study[6].
Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, personally overruled FDA staff scientists who were ready to review Moderna's application and issued the refusal-to-file letter[1][2]. This reversal and his decision to overturn career scientists' recommendations signal broader concerns about decision-making at the FDA, particularly regarding vaccine scrutiny, which has been attributed partly to vaccine skepticism seeping into the agency from leadership, including health secretary Robert F. Kennedy Jr.[2].
The FDA has set a target action date of August 5, 2026, to make its decision on Moderna's flu vaccine application[6][8]. Moderna aims to make the vaccine available later in 2026 pending approval, positioning the vaccine to launch before the 2026-2027 flu season.
History
5 sources