![mFlusiva: The First mRNA Flu Vaccine](https://cdn.slatesource.com/e/4/a/e4adc3bc-9edd-402e-a05a-a91351f7ca64.webp) # mFlusiva: The First mRNA Flu Vaccine - [Made in Slatesource](https://slatesource.com/@steph/mflusiva-the-first-mrna-flu-vaccine) - By [Steph](https://slatesource.com/@steph) - Created on Aug 7, 2026 Relative efficacy vs best standard flu shot 26.6% better (95% CI: 16.7 to 35.4) Phase 3 trial participants across 11 countries 40,805 adults Time to update a traditional egg-based flu vaccine up to 6 months Time to update an mRNA flu vaccine as little as 6 weeks Americans hospitalised by flu in the 2024-25 season at least 600,000 VRBPAC advisory vote to recommend approval (June 2026) unanimous Approval status for ages 50 to 64 standard approval Approval status for ages 65 and older accelerated approval ## How mRNAmRNA FluFlu VaccinesVaccines WorkWork TraditionalTraditional fluflu shotsshots are mademade by growinggrowing influenzainfluenza virusvirus insideinside fertilisedfertilised henshens' eggseggs, then killingkilling it, purifyingpurifying the proteinsproteins, and formulatingformulating the dosedose. The processprocess takestakes up to sixsix monthsmonths, whichwhich meansmeans healthhealth authoritiesauthorities mustmust guessguess in FebruaryFebruary whichwhich strainsstrains will circulatecirculate the followingfollowing winterwinter. When they guessguess wrongwrong, seasonalseasonal protectionprotection can dropdrop to as lowlow as 20%. mFlusivamFlusiva skipsskips the eggseggs entirelyentirely. ScientistsScientists taketake the geneticgenetic sequencesequence of the targettarget fluflu strainsstrains, encodeencode the relevantrelevant surfacesurface proteinsproteins as mRNAmRNA strandsstrands, and wrapwrap them in lipidlipid nanoparticlesnanoparticles, the samesame deliverydelivery systemsystem usedused in COVID-19COVID-19 vaccinesvaccines. InjectedInjected into your armarm, the mRNAmRNA tellstells your cellscells to brieflybriefly produceproduce fluflu proteinsproteins. Your immuneimmune systemsystem recognisesrecognises them, buildsbuilds antibodiesantibodies, and destroysdestroys the mRNAmRNA withinwithin daysdays. No livelive virusvirus everever entersenters the equationequation. SpeedSpeed is the definingdefining advantageadvantage. If a newnew strainstrain emergesemerges mid-seasonmid-season, an mRNAmRNA updateupdate couldcould be readyready in weeksweeks ratherrather than the followingfollowing yearyear. journey·5 Dates # From trial to approval: the turbulent road to mFlusiva Event / Date "FDA vaccine director Vinay Prasad signs a refusal-to-file letter. Objection: trial compared mFlusiva to a standard-dose shot, not the high-dose version recommended for over-65s. "Industry and public health experts push back hard. FDA Commissioner Makary reverses the decision via a Type A dispute meeting, letting Moderna split the approval by age group. "An independent FDA advisory committee, VRBPAC, reviews the Phase 3 data and votes unanimously to recommend approval. "FDA grants standard approval for ages 50-64 and accelerated approval for 65 and older. mFlusiva becomes the first mRNA flu vaccine in US history. "ACIP, the CDC panel that converts approvals into insurance-covered recommendations, remains frozen. A federal court blocked the committee after RFK Jr. fired all 17 members in March 2026. > This is an important advance. Influenza remains a serious public health challenge, and better vaccines mean fewer hospitalisations and deaths each year. # Will mFlusiva change how you think about the annual flu shot? The political storm around this approval was louder than the science. A vaccine with a 27% efficacy advantage survived a politicised FDA refusal, a hostile HHS secretary, and a frozen advisory committee. Does that story make you more or less likely to get it this autumn? No comments yet. Be the first. Log in to comment subtitle: Who can get mFlusiva in autumn 2026? 0% \- Adults 50 to 64: fully approved. Standard coverage expected from most insurers once ACIP issues its recommendation. \- Adults 65 and older: accelerated approval. Confirmatory trial vs high-dose comparator required; ACIP recommendation pending court ruling. \- Under 50: not yet approved. Clinical trials in younger adults are ongoing; a broader age-group submission is planned. \- High-risk under-50s (asthma, heart disease, diabetes): mFlusiva is not yet authorised for this group. Standard options remain available. \- Already vaccinated with a standard flu shot this season: no need to switch. mFlusiva launches for the 2026-27 season. What happens next. Moderna expects mFlusiva to be available for the 2026-27 respiratory season. The bigger bottleneck is ACIP: without a formal CDC recommendation, most insurance plans are not required to cover the shot at no cost. A First Circuit ruling on Kennedy's committee terminations could unlock that pathway. Separately, Moderna is developing a combined mRNA vaccine covering flu and COVID-19 in one injection, with a regulatory submission planned for 2027. [FDA approval page for mFlusiva (mRNA-1010), approved August 5, 2026](https://www.fda.gov/vaccines-blood-biologics/vaccines/mflusiva?utm_source=slatesource) [STAT News: full coverage of the mFlusiva FDA approval and the road to it](https://www.statnews.com/2026/08/05/fda-approves-moderna-mflusiva-first-mrna-flu-vaccine/?utm_source=slatesource)