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[HEALTH] · United States · 52 sources

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Part of situation: Moderna mRNA flu vaccine mFlusiva US launch and scrutiny (7 clusters)

Moderna's mFlusiva mRNA Flu Vaccine Approved by US FDA

Moderna mFlusiva FDA approval mRNA flu vaccine adults 50+

The U.S. Food and Drug Administration has granted approval to Moderna’s mFlusiva, the first seasonal influenza vaccine that uses messenger‑RNA technology. The approval covers adults aged 50‑64 with full approval based on a late‑stage trial of about 40,000 participants that showed roughly a 27 % reduction in flu cases compared with a standard vaccine. Adults 65 and older receive accelerated approval, relying on a smaller study that demonstrated a strong immune response versus a high‑dose flu shot, with a confirmatory trial required. No major safety concerns were identified; the most common adverse events were mild injection‑site pain, fever, headache, fatigue and muscle aches. An independent FDA advisory committee voted unanimously in June to recommend the vaccine. After an earlier refusal to file, the agency reversed its decision following industry pressure and a public dispute. Moderna expects limited supplies of mFlusiva to reach selected retailers for the 2026‑27 flu season. Health Secretary Robert F. Kennedy Jr. has publicly criticized mRNA vaccines, but the FDA’s approval marks a significant milestone for seasonal flu prevention in the United States.

Entities

Adults aged 50 and older · Food and Drug Administration · Food and Drug Administration (FDA) · Moderna · Moderna Inc. · Robert F. Kennedy Jr. · Stéphane Bancel · U.S. Food and Drug Administration · U.S. Food and Drug Administration (FDA) · United States · mFLUSIVA · mFlusiva (mRNA‑1010)

Claims

What the coverage asserts, and how many sources carry each claim.

Sources

FDA Clears First mRNA Flu Vaccine for Adults 50 and Older - The Garden Magazine [thegardenmagazine.com]
FDA Approves First mRNA-Based Flu Vaccine [www.lootpress.com]
Les États-Unis approuvent le premier vaccin antigrippal à ARN messager [www.netcost-security.fr]
অনুমোদন পেল বিশ্বে প্রথম এমআরএনএ ফ্লু টিকা [anannya.com.bd]
অনুমোদন পেল বিশ্বে প্রথম এমআরএনএ ফ্লু টিকা [chandpurtimes.com]
EUA aprovam primeira vacina contra gripe com tecnologia de RNA mensageiro - Revista Soberana [revistasoberana.com.br]
FDA approves Moderna’s mRNA-based vaccine for the flu - The Crystal Eyes [thecrystaleyes.com]
FDA Approves mFlusiva, First mRNA Flu Vaccine in the United States » ¡Que Onda Magazine! [queondamagazine.com]
ΗΠΑ: Πράσινο φως στην πρώτη mRNA εποχική γρίπη της Moderna - SBC TV [www.sbctv.gr]
FDA Approves the First Ever mRNA Flu Vaccine From Moderna [drug-dev.com]
Aprueban inyección ARNm contra la gripe con una tasa de reacciones adversas del 75% [cienciaysaludnatural.com]
Don’t Shed on Me: How the FDA’s New mRNA Flu Shot Turns Grandma Into a Walking Bioweapon [newstarget.com]
Saga s cepivom mRNA proti gripi v ZDA srečno končana [slo-tech.com]
For Moderna’s Greenlit mRNA Flu Vaccine, Payoff Is a Ways Off [www.thedailyupside.com]
¡Aprobada por la FDA! Moderna lanza la primera vacuna antigripal de ARNm en EEUU [2001online.com]
Don’t Take the Flu Shot — It’s Even More Dangerous Now [livingtraditionally.com]
FDA aprueba mFlusiva, la primera vacuna de ARNm contra la gripe para mayores de 50 - Notiulti [www.notiulti.com]
ФДА ДАДЕ ЗЕЛЕНО СВЕТЛО ЗА ПРВАТА МРНК ВАКЦИНА ПРОТИВ ГРИП: Новиот препарат на „Модерна“ наменет за лица над 50 години [denesen.mk]
ФДА даде зелено светло за првата мРНК вакцина против грип: Новиот препарат на „Модерна“ наменет за лица над 50 години - Press24 [press24.mk]
A new flu vaccine geared to older people is coming soon [www.ksfr.org]
Estados Unidos aprobó la primera vacuna antigripal de ARN mensajero para adultos mayores [eldebate.com.ar]
Jóváhagyták az első mRNS-alapú influenza vakcinát az USA-ban [qubit.hu]
FDA: Ενέκρινε το πρώτο εμβόλιο mRNA κατά της γρίπης - 26,6% υψηλότερη αποτελεσματικότητα έναντι παλιού [www.thestival.gr]
Voici ce que le premier vaccin contre la grippe à ARNm pourrait signifier pour la saison de la grippe [issues.fr]
ФДА даде зелено светло за првата мРНК вакцина против грип: Новиот препарат на „Модерна“ наменет за лица над 50 години - Независен Весник [nezavisen.mk]
Week In Review | The Regulatory Review [www.theregreview.org]
بشرى لكبار السن، هيئة الأدوية الأمريكية تقر أول لقاح إنفلونزا بتقنية الحمض النووي [www.vetogate.com]
After Initial Rejection, FDA Greenlights First mRNA Flu Vaccine. [thenationalpulse.com]
Con ARN mensajero: los detalles de la nueva vacuna antigripal aprobada por la FDA [www.prensalibre.com]
Aprueban en EU primera vacuna de ARNm contra influenza para mayores de 50 [www.am.com.mx]
FDA Approves Moderna’s mFLUSIVA as First mRNA Flu Vaccine in United States - Weekly Voice [weeklyvoice.com]
FDA aprova vacina de mRNA contra gripe da Moderna após rejeitar pedido em fevereiro [www.infomoney.com.br]
Moderna recibe luz verde de la FDA para su primera vacuna antigripal ARNm [vanguardia.com.mx]
هيئة الأدوية تقر أول لقاح إنفلونزا بتقنية الحمض النووي الريبوزي المرسال في الولايات المتحدة [arabic.euronews.com]
ABD'de ilk mRNA grip aşısı onaylandı [tr.euronews.com]
Le régulateur américain autorise le premier vaccin antigrippal à ARN messager [fr.euronews.com]
La agencia del medicamento de EEUU aprueba la primera vacuna antigripal de ARNm [es.euronews.com]
Estados Unidos: regulador aprova primeira vacina contra a gripe com mRNA [pt.euronews.com]
Aprueban la primera vacuna de ARNm contra la influenza estacional [www.excelsior.com.mx]
FDA Approval Of Moderna’s mRNA Flu Vaccine Is Great News. Here’s Why [ca.news.yahoo.com]
Moderna wins FDA approval for first mRNA-based flu shot [americanbazaaronline.com]
EUA aprovam a primeira vacina da gripe com tecnologia mRNA [pplware.sapo.pt]
Un nuevo tipo de vacuna contra la gripe está en camino [laopinion.com]
New kind of flu shot is on the way as the FDA approves Moder. . . [www.semissourian.com]
FDA Approves Moderna's mRNA-Based Flu Vaccine | PharmExec [www.pharmexec.com]
5 things to know about Moderna’s new mRNA flu vaccine [triblive.com]
First mRNA flu shot approved by FDA bodes well for improving drugs of the future [www.downtoearth.org.in]
موافقة أميركية على لقاح موديرنا المضاد للإنفلونزا [www.aajeg.com]
美國批准全球首款mRNA流感疫苗 效力較傳統高27% [www.stheadline.com]
Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain - MedCity News [medcitynews.com]
Here’s what the first mRNA flu vaccine could mean for flu season [www.sciencenews.org]
A new flu vaccine geared to older people is coming soon [www.kpbs.org]