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  "description": "“Refuse-to-file.”",
  "path": "/us-govt-refuses-to-review-modernas-inadequate-mrna-flu-shot-application/",
  "publishedAt": "2026-02-12T01:19:46.000Z",
  "site": "https://goodoil.news",
  "tags": [
    "Centrist",
    "**Read more over at The Washington Post**",
    "** _Receive our free newsletter here_**"
  ],
  "textContent": "Summarised by Centrist\n\n**The US Food and Drug Administration has refused to review Moderna’s mRNA flu vaccine application, issuing a rare “refuse-to-file” letter and deeming it “inadequate for review” for lacking an “adequate and well-controlled” study.**\n\nRefuse-to-file letters are uncommon. A study in JAMA Internal Medicine found that over a decade, only 4 per cent of nearly 2,500 applications received such letters.\n\nThe filing included results from two Phase 3 trials in adults aged 50 and older. In one, the shot was compared with Fluarix, a standard-dose flu vaccine.\n\nThe FDA had previously suggested the company compare its product to a higher-dose flu shot for older adults, who are most at risk from influenza.\n\nThe regulator did not publicly cite safety or efficacy concerns. Instead, it focused on the structure of the evidence submitted.\n\nModerna said the agency had earlier indicated its trial design was “acceptable,” making the refusal unexpected.\n\nFDA vaccine chief Vinay Prasad has urged the agency to “rethink its framework for annual flu shots.”\n\nThe current administration has also pulled back funding from several mRNA projects, with Health Secretary Robert F. Kennedy Jr. saying the government was “moving beyond the limitations of mRNA and investing in better solutions.”\n\nModerna’s application has been accepted for review in the European Union, Canada and Australia. The company has requested a formal meeting with the FDA to clarify what additional evidence would be required.\n\n**Read more over at The Washington Post**\n\n** _Receive our free newsletter here_**",
  "title": "US govt refuses to review Moderna’s ‘inadequate’ mRNA flu shot application",
  "updatedAt": "2026-02-12T01:19:46.000Z"
}