{
  "$type": "site.standard.document",
  "bskyPostRef": {
    "cid": "bafyreibkzr6cxjiqw3tjtlrijyyn43ypj2noiwqbprim2hbjmuqbj4zifa",
    "uri": "at://did:plc:sl2hrcwo6voaorzsr26d3bo2/app.bsky.feed.post/3mom3nl47ozq2"
  },
  "coverImage": {
    "$type": "blob",
    "ref": {
      "$link": "bafkreihkddekrgicnie5hnxhirftly7e457uppnbvhuwi5nvxt3b72zase"
    },
    "mimeType": "image/jpeg",
    "size": 84636
  },
  "description": "Four months after refusing to review Moderna's application, FDA advisers appear ready to endorse the same vaccine based on largely the same evidence.",
  "path": "/poised-to-approve-mrna-flu-vaccine/",
  "publishedAt": "2026-06-19T00:30:32.000Z",
  "site": "https://goodoil.news",
  "tags": [
    "Maryanne Demasi",
    "accused",
    "stated",
    "18 June",
    "briefing documents",
    "MD Reports"
  ],
  "textContent": "Maryanne Demasi\n_Maryanne Demasi PhD is an investigative journalist who writes for online media and top-tiered medical journals. For over a decade, she was a TV presenter for the Australian Broadcasting Corporation (ABC)._\n\nEarlier this year, the FDA issued Moderna a Refusal-to-File letter, effectively rejecting the company’s application before a full scientific review could begin.\n\nAt the centre of the decision was Vinay Prasad, then director of the FDA’s Center for Biologics Evaluation and Research (CBER), who argued that Moderna had tested its vaccine against the wrong benchmark.\n\nBecause the vaccine was intended for older adults, the FDA said Moderna should have compared it against one of the influenza vaccines routinely recommended for people aged 65 and older, rather than a standard-dose flu shot.\n\nThe decision immediately sparked controversy.\n\nCritics accused the FDA of moving the goalposts after the trial had already been completed. Others argued that the study design should never have been accepted in the first place.\n\nBut lost in the dispute was a simpler question – how well did the vaccine actually work?\n\nModerna’s phase-three trial enrolled more than 40,000 adults aged 50 years and older across 11 countries. Participants received either the company’s mRNA influenza vaccine, mRNA-1010, or a licensed standard-dose influenza vaccine.\n\nThe results, published in the _New England Journal of Medicine_ in May, showed that Moderna’s vaccine reduced laboratory-confirmed influenza-like illness by **26.6 per cent** relative to the comparator vaccine.\n\nBut the absolute difference was far less impressive.\n\nInfluenza-like illness occurred in **2.8 per cent** of participants who received the standard flu vaccine, compared with **2.0 per cent** of those who received mRNA-1010 – **an absolute difference of just 0.8 per cent**.\n\nImportantly, the trial was not designed to show that the vaccine prevented hospitalisations or deaths from influenza.\n\nGiven that modest benefit, the harms of the vaccine come into sharper focus.\n\nAmong recipients of Moderna’s vaccine, fatigue was reported in **45 per cent** , headache in **38 per cent** , muscle aches in **35 per cent** , and chills in **23 per cent**.\n\nThose are strikingly high rates for a vaccine intended to be given every year.\n\nMost notably, reactions severe enough to interfere with normal daily activities occurred in **6.4 per cent** of vaccine recipients, compared with just **1.0 per cent** among those who received the licensed flu vaccine – **a six-fold difference**.\n\nIn other words, for every additional case of influenza-like illness prevented, several people experienced reactions serious enough to disrupt their normal activities.\n\nWhether that trade-off is worthwhile is ultimately a value judgement.\n\nSome people may question a vaccine that leaves them feeling as though they have come down with the very illness it is designed to prevent.\n\nThe controversy deepened when documents showed that the FDA had told Moderna early on that its chosen comparator was “acceptable”.\n\nIn written feedback provided in April 2024, before enrolment began and well before Prasad arrived at CBER, the agency stated:\n\n> _While we agree it would be**acceptable** to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study, we **recommend** you use a vaccine preferentially recommended for use in older adults. [emphasis added]_\n\nThat distinction between “acceptable” and “recommended” would prove consequential.\n\nModerna proceeded with a study design that the agency had explicitly deemed acceptable. Yet only after the trial was completed did the comparator become the primary reason for refusing to review the application.\n\nThe decision was not widely supported among Prasad’s colleagues and reportedly caught some senior officials by surprise, including then-Commissioner Dr Marty Makary.\n\nBut the rejection was short-lived.\n\nAccording to people familiar with the matter, Makary was summoned to the White House shortly afterwards and urged to find a path forward for Moderna’s application.\n\nModerna subsequently met with FDA officials and revised its regulatory strategy.\n\nThe company agreed to seek traditional approval for adults aged 50 to 64 years and accelerated approval for those aged 65 years and older. It also committed to conducting a post-marketing study in older adults – the population at the centre of the FDA’s concerns.\n\nThat was enough for the agency to reverse course and accept the application for review.\n\nThis week, on 18 June, FDA advisers will meet to discuss the vaccine.\n\nThe comparator controversy that derailed Moderna’s application earlier this year now appears largely resolved.\n\nThe briefing documents just released ahead of the meeting read less like an examination of whether Moderna’s vaccine deserves approval, and more like a roadmap _to_ approval.\n\nThat leaves a much simpler question.\n\n**Does a reduction in influenza-like illness from 2.8 per cent to 2.0 per cent justify a six-fold _increase_ in vaccine reactions severe enough to interfere with daily activities?**\n\nMy guess is that the FDA’s rubber-stamping advisory committee will conclude that it _does_ – and that Moderna’s new vaccine will sail through the review process and secure approval.\n\nThis article was originally published by MD Reports.",
  "title": "Poised To Approve mRNA Flu Vaccine",
  "updatedAt": "2026-06-19T00:30:32.808Z"
}