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    "original_url": "https:\/\/www.nytimes.com\/2026\/02\/10\/health\/fda-moderna-mrna-flu-vaccine.html?campaign_id=9&emc=edit_nn_20260211&instance_id=170910&nl=the-morning&regi_id=122976029&segment_id=215096&user_id=b25c5730c89e0c73f75709d8f1254337",
    "parsed_content": "U.S. Health PolicyCovid Shots\u2018Naturally Derived\u2019 DyesFederal Autism PanelApproach to ImmunizationVaccine ChangesAdvertisementSKIP ADVERTISEMENTSupported bySKIP ADVERTISEMENTThe vaccine maker\u2019s shots involve the successful Covid vaccines\u2019 RNA technology. Health Secretary Robert F. Kennedy Jr. has broadly rejected it, canceling millions of dollars in research projects.Listen to this article \u00b7 7:17 min Learn moreShare full articleModerna is a pioneer in using mRNA technology, first with the Covid vaccine. Its flu shot was being developed for people 50 and older.Credit...Brian Snyder\/ReutersBy Christina Jewett and Rebecca RobbinsFeb. 10, 2026The vaccine maker Moderna said on Tuesday that the Food and Drug Administration had notified the company that the agency would not review its mRNA flu vaccine, the latest sign of federal health policy that has become hostile to vaccine development.Dr. Vinay Prasad, the agency\u2019s top vaccine regulator, rejected the company\u2019s application for approval over a concern that Moderna\u2019s clinical trial had compared its experimental vaccine against a product the agency did not consider the best on the market. People in the comparison group received Fluarix Quadrivalent, a flu vaccine sold by GSK.Moderna had spent years and hundreds of millions of dollars testing its flu vaccine, enrolling 41,000 people and aimed at a market of adults ages 50 and older. The company concluded that its shot was superior to GSK\u2019s product.Dr. Stephen Hoge, the company\u2019s president, said in an interview on Tuesday that the new flu vaccine was designed to be better tailored for a single nation than the ones that tended to be used by an entire hemisphere. He also said the F.D.A. had earlier indicated support for the company\u2019s study plan.\u201cThis refusal to start a review is all confusing, to say the least,\u201d Dr. Hoge said, adding: \u201cIt is surprising, and we\u2019re trying to understand what has changed.\u201dA spokesman for the Department of Health and Human Services, which oversees the F.D.A., said the agency did not comment on communications with individual applicants for drug approval.Moderna said it had received what is known as a \u201crefuse to file\u201d letter from the agency, meaning that the company tried to submit an application for approval, but was dismissed. Such cursory rejections are unusual; the agency tends to complete a thorough review before denying approval.Moderna said the agency\u2019s letter did not cite any specific concerns about the product\u2019s safety or effectiveness. A journal article published by company scientists last year concluded that the vaccine was safe. It reported that some of the company\u2019s research showed that the vaccine had generated strong immune responses against both the A and B strains of the flu, though some results indicated that the vaccine seemed to work better against the A strain of the flu rather than the B strain.A strains of the flu tend to cause more flu cases and more severe illness than B strains do.This latest move by the F.D.A. reflects expansion of a new policy under Health Secretary Robert F. Kennedy Jr., who has repeatedly criticized the mRNA technology used most successfully against Covid and made by both Moderna and Pfizer. Recognized with a Nobel Prize in Physiology or Medicine in 2023, the technology instructs the body to produce a fragment of a virus that then sets off the body\u2019s immune response.But Mr. Kennedy has scuttled the use of mRNA in vaccines and canceled hundreds of millions of dollars in funding for research using the technology, claiming it is not safe or effective. During his first year as health secretary, he has quashed several projects involving the technology, including an effort by Moderna to develop a shot against bird flu.Pfizer has been in a race with Moderna to develop an mRNA flu vaccine. However, Dr. Marty Makary, the F.D.A. commissioner, has alluded critically to Pfizer\u2019s vaccine, saying in news media interviews that it failed to work in seniors in a clinical trial and suggesting it would not pass agency muster.Moderna spent years on the studies for a vaccine that was meant to improve on egg-based and other methods to combat the flu, allowing nations to specifically select the strain they hoped to target.Dr. Hoge said the company met with the F.D.A. about the study and understood that the decision of which vaccine to use in comparison would be acceptable, albeit a \u201creview issue,\u201d he recounted. He said the company had requested an additional meeting with the agency about its decision to reject the application.Blackstone, the private equity company, had invested $750 million in the development of Moderna\u2019s flu shot, in addition to the vaccine maker\u2019s own support for the large clinical trial, he said.No country has approved an mRNA flu vaccine, although Mr. Hoge said Moderna\u2019s product was being reviewed in Europe, Canada and Australia. Dr. Prasad\u2019s letter to Moderna said the reason for the refusal was that the company had not run an \u201cadequate and well-controlled\u201d study but had compared its product with a flu vaccine that \u201cdoes not reflect the best-available standard of care.\u201dIn recent months, Dr. Prasad has held drug companies to standards that were different from what they were expecting based on previous agency guidance, generating backlash from the biotech and pharmaceutical industries. In November, a long list of biotech investors and chief executives wrote a letter of concern about \u201cdecisional volatility\u201d and turmoil at the F.D.A.Dr. Makary has defended Dr. Prasad\u2019s decisions and said the agency\u2019s drug approvals last year were in line with recent years.In a large clinical trial, Pfizer\u2019s experimental mRNA vaccine against the flu was found to be at least as good as a comparison product against A strains of the flu, but not against B strains. Funded by Pfizer, the study compared the company\u2019s experimental vaccine against Fluzone, a shot on the market sold by Sanofi.In an interview on \u201cFox & Friends\u201d in November, Dr. Makary criticized Pfizer\u2019s data, though he did not name the company. \u201cWe\u2019re not just going to rubber-stamp new products that don\u2019t work, that fail in a clinical trial,\u201d he said. \u201cIt makes a mockery of science if we\u2019re just going to rubber-stamp things with no data.\u201dIn another interview the next month with NPR, Dr. Makary suggested that Pfizer\u2019s vaccine did not meet the agency\u2019s criteria for approval. \u201cI personally like mRNA technology. But this mRNA flu shot in its randomized control trial in seniors failed. It showed no benefit,\u201d he said.He added: \u201cWell, we basically said, We\u2019re not interested in approving a drug that has failed in its Phase 3 randomized trial.\u201dPfizer said in a statement on Tuesday evening that it was engaged in discussions with health officials about the road to approval for mRNA flu vaccines. The company declined to comment on its timetable for seeking or winning approval.Perhaps no vaccine developer has been harder hit than Moderna, as federal health officials have turned against mRNA technology and some vaccines. Demand for the company\u2019s Covid vaccine has declined considerably, after generating huge sales at the height of the pandemic. The F.D.A. also narrowed approval of Covid shots for the season that began last fall. Moderna\u2019s stock has plummeted by more than 90 percent since its peak in August 2021.Moderna has said it is halting plans for late-stage studies of some experimental vaccines aimed at preventing infectious diseases and infections that lurk in the body. Late-stage studies of Moderna\u2019s experimental cancer vaccines are expected to continue unimpeded.Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.See more on: Food and Drug Administration, Moderna Inc, Robert F. Kennedy Jr., Donald TrumpRead 175 commentsShare full articleRelated ContentAdvertisementSKIP ADVERTISEMENT",
    "ai_headline": "F.D.A. Rejects Moderna\u2019s M.R.N.A. Flu Vaccine, a Sign of Policy Shift",
    "ai_simplified_title": "FDA Rejects Moderna Flu Vaccine Amidst Policy Shift",
    "ai_excerpt": "The FDA rejected Moderna's mRNA flu vaccine, signaling a shift in federal health policy under Health Secretary Robert F. Kennedy Jr. The rejection is based on concerns about the clinical trial's comparison product. Moderna's stock has plummeted since its peak.",
    "ai_subject_tags": [
        "FDA",
        "Moderna",
        "mRNA Vaccine",
        "Flu Vaccine",
        "Robert F. Kennedy Jr.",
        "Vaccine Policy",
        "Vaccine Development"
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    "ai_context_type": "News",
    "ai_context_details": {
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        "perspective": "neutral",
        "audience": "general",
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