Moderna announced the Food and Drug Administration (FDA) will review its new mRNA flu vaccine, changing course less than two weeks after the agency said it refused to accept Moderna’s application.
In an announcement on Wednesday, Moderna said the FDA had reversed course and would review the vaccine with a “revised regulatory approach.”
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FDA says it won’t review
The process began last week, when Moderna submitted a review proposal to the FDA for a new mRNA seasonal flu vaccine. The vaccine would be the first of its kind following the rapid development of mRNA vaccines during the COVID-19 pandemic.
In response to Moderna’s application, the FDA declined to review the proposal and stated that it lacked an “adequate and well-controlled” study.
The decision left Moderna and other scientists stunned, with Moderna President Dr. Stephen Hoge telling CNN, “the complete stunner here is, at no point in any of this, did anybody say that it was not adequate.”
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The federal government distributed 977 million COVID-19 vaccine doses since the beginning of the COVID-19 pandemic.
Moderna conducted a 40,700-person clinical trial and said the FDA had previously agreed to the plan in 2024. But that was before Dr. Vinay Prasad was appointed to the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine regulation.
Prasad has been an outspoken critic of the government’s response to the COVID-19 pandemic and its vaccines. He was appointed to his position in 2025.
FDA changes course
After the refusal, Moderna reached out to the FDA for clarification on what was lacking, and “proposed a revised regulatory approach.” It amended its submission, seeking full approval for adults aged 50 to 64 and an accelerated approval for adults 65 and older.
The FDA accepted the amended application and will review the vaccine with the goal of approving it ahead of 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,” Moderna CEO Stéphane Bancel said in a statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
