• The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval. • Therefusal was revealed last weekin a sharply worded press release from Moderna. • Subsequent reporting found that the decision was made by political appointee Vinay Prasad, the Trump administration’s top vaccine regulator, whooverruled a team of agency scientistsand a top career official in rejecting Moderna’s application. • Inan announcement Wednesday morning, Moderna said the FDA has now agreed to review its vaccine after the company held a formal (Type A) meeting with the FDA and proposed a change to the regulatory pathways used in the application. • “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Moderna’s CEO, said in the announcement. • “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.” The agency is expected to provide a decision on the vaccine by August 5, 2026.
Article Summaries:
- The FDA has overturned its earlier refusal to review Moderna’s mRNA flu vaccine, mRNA‑1010, after a formal Type A meeting and a change to the regulatory pathway. The initial rejection, led by political appointee Vinay Prasad, overruled agency scientists and a career official, citing that the Phase 3 trial used standard‑dose influenza vaccines instead of the high‑dose product recommended for seniors. Moderna agreed to add a high‑dose comparison arm and provide additional analysis. The agency now plans to review the application, with a decision expected by August 5, 2026.
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