---
title: "mRNA vaccines vindicated: mFlusiva approval and subsequent data after HHS cancellations"
id: "stat-news-0-opinion-one-year-since-kennedy-canceled-mrna-vaccine-projects-science-shows-how"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-0-opinion-one-year-since-kennedy-canceled-mrna-vaccine-projects-science-shows-how"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/08/06/mflusiva-fda-mrna-flu-vaccine-rfk-jr/?utm_campaign=rss"
published_at: "2026-08-06T12:10:18.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# mRNA vaccines vindicated: mFlusiva approval and subsequent data after HHS cancellations
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-0-opinion-one-year-since-kennedy-canceled-mrna-vaccine-projects-science-shows-how
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/08/06/mflusiva-fda-mrna-flu-vaccine-rfk-jr/?utm_campaign=rss)
- **Published At:** 2026-08-06T12:10:18.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The FDA approved **mFlusiva**, the first licensed mRNA seasonal influenza vaccine in the U.S., following unanimous advisory committee endorsements for adults 50–64 and 65+. - One year earlier, HHS under Health Secretary Robert F. Kennedy Jr. canceled 22 federally funded **mRNA** vaccine projects, halting roughly $500 million in platform investment. - Moderna’s Phase 3 influenza trial enrolled 40,805 adults across 11 countries and showed **mFlusiva** outperformed a licensed standard-dose flu shot by 26.6%, including benefit in adults over 65. - The FDA initially refused to review Moderna’s application citing the use of a standard-dose rather than high-dose comparator for older adults; the agency reversed that decision 15 days later after public outcry. - Independent scientific developments continued after the HHS cancellations: a five-year individualized **mRNA** therapy plus pembrolizumab reduced melanoma recurrence or death by 49% and distant metastasis by 59% in reported results. - A Memorial Sloan Kettering Phase 1 report found that among pancreatic cancer patients whose immune systems responded to an individualized **mRNA** vaccine, nearly 90% were alive up to six years after dosing; the author notes confirmation requires larger randomized trials. - A gene-editing therapy delivered as mRNA in a lipid nanoparticle enabled a child (KJ) with a rare disorder to survive and develop—an example of the platform’s role in ultra-rare disease therapies. - The author argues the U.S. is ceding leadership in the platform to private capital and foreign governments, with China increasingly originating programs, and recommends Congress restore canceled contracts and require platform funding decisions go through scientific review. - The piece emphasizes that the evidence cited (Phase 3 trial, cancer survival data, and rare-disease treatment) contradicts the administration’s rationale for defunding the **mRNA** platform.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) Opinion[First Opinion](https://www.statnews.com/category/first-opinion/) # One year since Kennedy canceled mRNA vaccine projects, science shows how wrong he was ## Congress must restore mRNA vaccine research funding to keep the U.S. competitive * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * Email this article * [Share this article](https://www.statnews.com/2026/08/06/mflusiva-fda-mrna-flu-vaccine-rfk-jr/?utm_campaign=rss) ![](https://www.statnews.com/wp-content/uploads/2026/06/GettyImages-2276972565-645x645.jpg) Health secretary Robert F. Kennedy Jr.Heather Diehl/Getty Images By Jeff Coller Aug. 6, 2026 Coller is Bloomberg distinguished professor of RNA biology and therapeutics at Johns Hopkins University and a co-founder of the Alliance for mRNA Medicines. On Wednesday, the Food and Drug Administration’s approved [mFlusiva](https://www.statnews.com/2026/08/05/fda-approves-moderna-mflusiva-first-mrna-flu-vaccine/), the first mRNA seasonal influenza vaccine ever licensed in this country. In June the agency’s own [advisory committee voted unanimously](https://www.statnews.com/2026/06/18/fda-mrna-flu-vaccine-vrbpac-advisers-endorse-moderna-shots/) that its benefits outweigh its risks in adults 50 to 64, then unanimously again for adults 65 and older. Nine independent experts, appointed by this government, could not produce a single vote against it. Wednesday was also an anniversary. On Aug. 5, 2025, the Department of Health and Human Services [killed 22 mRNA vaccine development projects worth roughly $500 million](https://www.statnews.com/2025/08/05/mrna-vaccine-development-canceled-by-kennedy-hhs/) and ordered a halt to federal investment in the platform. Advertisement Health secretary Robert F. Kennedy Jr. did not hedge about why. He claimed the data showed these vaccines fail to protect effectively against upper respiratory infections like Covid and flu, and that the money would move to safer platforms. He also told the country the technology poses more risks than benefits and can prolong pandemics, neither of which the evidence supports. I have worked on messenger RNA for more than three decades, and one of my former graduate students helped design the mRNA sequence inside the Moderna Covid vaccine, so I am not a neutral party here. But the secretary made a claim about what the evidence showed, and 12 months is long enough for evidence to answer back. Begin with what was already on the record. Five weeks before Kennedy abandoned mRNA research, on June 30, 2025, Moderna reported results from a Phase 3 influenza trial in 40,805 adults across 11 countries. The mRNA vaccine now known as mFlusiva outperformed a licensed standard-dose flu shot by 26.6%, and the benefit held in patients over 65. Kennedy’s claim that the data showed mRNA fails against influenza was made 36 days after the data showed the opposite. Advertisement Related Story ![](https://www.statnews.com/wp-content/uploads/2025/05/AdobeStock_525738206_Editorial_Use_Only-768x432.jpeg) ### ![](https://www.statnews.com/wp-content/themes/stat/images/home/statplus.svg) [STAT Plus: Moderna launches early trial of Ebola mRNA vaccine](https://www.statnews.com/2026/08/05/biotech-news-moderna-launches-early-ebola-mrna-vaccine-trial/) Then came the mFlusiva application itself. On Feb. 3 of this year, the [FDA refused to review it](https://www.statnews.com/2026/02/10/fda-refuses-review-moderna-flu-vaccine-application/). The letter was signed personally by Vinay Prasad, who at the time ran the center that evaluates vaccines, which is not how such letters normally leave the building. His sole objection was that Moderna had tested the vaccine against a standard-dose flu shot rather than the high-dose version preferred for people over 65. The criterion he invoked appears nowhere in the agency’s own influenza guidance, and his own center had told Moderna in writing that the standard-dose comparator was acceptable. Regulators in Europe, Canada, and Australia had accepted the identical application without difficulty. Fifteen days later, after one meeting and a public outcry, [the FDA reversed itself](https://www.statnews.com/2026/02/18/fda-moderna-reverse-course-flu-vaccine/), agreed to review the file, and set the decision date for Wednesday. Nothing about the evidence changed in those 15 days. Only the politics did. There is a contradiction here the administration has never resolved. The mRNA Covid vaccine is [an American government success story](https://www.statnews.com/2022/02/14/why-covid-19-vaccines-are-a-freaking-miracle/). Moderna’s vaccine was designed with the National Institutes of Health and paid for by the same department that killed the platform last August. It reached arms in 11 months under Operation Warp Speed, which President Trump still calls one of the great achievements of his first term. He is right about that. Published [analyses](https://www.thelancet.com/journals/laninf/article/PIIS1473-3099\(22\)00320-6/fulltext) credit Covid vaccination with [preventing](https://www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations) more than 3 million American deaths in its first two years. That achievement was delivered by mRNA. You cannot celebrate the miracle and defund the machinery that produced it. The rest of the year was worse for the secretary’s argument. In June, researchers [reported](https://www.oncology-central.com/keynote-942-study-pembrolizumab-vaccine-combination-cuts-melanoma-recurrence-by-49/) five-year results on an individualized mRNA therapy given with pembrolizumab after surgery for high-risk melanoma. Half a decade out, the combination therapy had cut the risk of recurrence or death by 49% and the risk of the cancer spreading to distant organs by 59%. In April, a Memorial Sloan Kettering team [reported](https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out) that among pancreatic cancer patients whose immune systems responded to an individualized mRNA vaccine, nearly 90% were alive as long as six years after their final dose of the vaccine. Five-year survival in that disease sits near 13%. This was a small Phase 1 study, and confirming the result requires a larger randomized trial. That trial is precisely the kind of research HHS cut. Advertisement Then there is KJ, the most famous toddler in biotech. February marked one year since he became the [first person](https://www.statnews.com/2025/05/15/crispr-gene-editing-landmark-first-ever-single-patient-genetic-fix-nejm-reports/) treated with a [gene-editing therapy built for his mutation alone](https://www.statnews.com/2025/05/26/what-kj-muldoon-crispr-gene-editing-treatment-means-for-interventional-genetics/). Half the infants born with his disorder never reach their first birthday. He is walking and talking. The editor that corrected his DNA reached his liver as messenger RNA inside a lipid nanoparticle, the same chemistry this administration defunded. Weeks after the anniversary, the FDA [proposed a new pathway](https://www.statnews.com/2026/02/23/fda-rare-disease-new-guidelines-plausible-mechanism-pathway/) to speed these therapies to children with ultra-rare disease, a pathway that runs straight through the platform the secretary wrote off. Despite Kennedy’s decision, the science has continued. Private capital and foreign governments are still building on mRNA, and a growing share of the world’s programs now originates in China. The United States invented this platform and is the only country walking away from it. Related Story ![](https://www.statnews.com/wp-content/uploads/2025/05/AdobeStock_525738206_Editorial_Use_Only-768x432.jpeg) ### ![](https://www.statnews.com/wp-content/themes/stat/images/home/statplus.svg) [STAT Plus: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy](https://www.statnews.com/2026/06/18/fda-mrna-flu-vaccine-vrbpac-advisers-endorse-moderna-shots/) There is a straightforward fix. Congress should restore the canceled contracts and require that any decision to fund or defund an entire medical platform go through scientific review rather than a press release. The secretary set that standard himself when he promised the country gold-standard science. He has it. It is in the New England Journal of Medicine, in a trial of 40,805 people, in five-year cancer survival curves, and in a boy with a rare disease who is walking and talking today. A year ago, Kennedy made his claims to the country, and the truth has been sitting in plain sight ever since. As long as he refuses to look, Americans will be less healthy and less safe, and the medicine that saves them will increasingly be made somewhere else. _Jeff Coller is the Bloomberg distinguished professor of RNA biology and therapeutics at Johns Hopkins University and a co-founder of the Alliance for mRNA Medicines._ * * * ###### Letter to the editor Have an opinion on this essay? [Submit a letter to the editor](https://www.statnews.com/submit-a-letter-to-the-editor/?subject=One%20year%20since%20Kennedy%20canceled%20mRNA%20vaccine%20projects,%20science%20shows%20how%20wrong%20he%20was). 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