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    Moderna

    Also known as Moderna Inc, Moderna Therapeutics, MRNA

    Moderna is a US biotechnology company built around mRNA medicines; in August 2026 its mFLUSIVA became the first FDA-approved mRNA flu vaccine and its fourth US product.[1][2] With Merck it also reported the first positive phase 3 trial of a personalised mRNA cancer therapy, while its second-quarter 2026 revenue was $145 million.[3][4]

    Editor reviewedStrict sourcingUpdated mRNA and next-gen vaccinesHealth and medicineLife sciences
    Key facts

    Moderna is a biotechnology company headquartered in Cambridge, Massachusetts. Its stated mission is to deliver impact through mRNA medicines.[1] It matters because its mRNA-1273 was one of the first two authorized mRNA COVID-19 vaccines. That vaccine encodes the SARS-CoV-2 spike protein in a lipid nanoparticle.[5] In 2026 it extended mRNA to seasonal flu and to cancer.[2][3]

    Platform

    Moderna’s vaccines use nucleoside-modified mRNA packaged in lipid nanoparticles. Nucleoside modification reduces innate immune activation, and the particle carries the RNA into cells.[6][7] The mRNA itself is non-integrating and is broken down by normal cellular processes.[8] Because it is made by in vitro transcription, changing a vaccine mainly means changing its sequence.[9] See how mRNA vaccines work.

    Products

    In August 2026 the FDA approved mFLUSIVA (mRNA-1010) for adults 50 and older. It is the first mRNA influenza vaccine and Moderna’s fourth US product, after Spikevax, mRESVIA and mNEXSPIKE.[2] Its phase 3 trial enrolled 40,805 adults in 11 countries.[10] It showed about 26.6% relative efficacy against confirmed influenza-like illness compared with a standard-dose vaccine.[11] The FDA granted standard approval for ages 50-64. Approval for 65 and older is accelerated and conditional on a confirmatory trial.[12]

    The path was not smooth. In February 2026 the FDA refused to file the application over the comparator vaccine chosen for older adults, then accepted an amended filing about a week later.[13] An FDA advisory committee later backed the vaccine unanimously.[14] After approval, the Infectious Diseases Society of America said the mRNA platform allows streamlined development and rapid responses to viral mutations.[15]

    Respiratory vaccines

    Before mFLUSIVA, Moderna’s US portfolio was built on respiratory vaccines. The FDA approved its RSV vaccine mRESVIA effective 31 May 2024 for adults 60 and older.[16] On 12 June 2025 the agency extended it to adults aged 18-59 at increased risk of RSV lower respiratory tract disease.[17] In August 2026 the FDA approved a label update based on an interim analysis of a pediatric study. It describes an imbalance in severe or hospitalized RSV disease among infants vaccinated at 5-7 months of age who had no prior RSV antibodies. The vaccine’s approved uses remain limited to adults.[18]

    The FDA approved the next-generation COVID-19 vaccine mNEXSPIKE on 30 May 2025. The first label covered previously vaccinated people aged 65 and older, or aged 12-64 with at least one high-risk condition.[19] Unlike Spikevax, which encodes the full stabilised spike protein, mNEXSPIKE encodes only the spike’s N-terminal and receptor-binding domains, at a 10-microgram dose.[20][21]

    For the 2026-2027 season the FDA asked manufacturers to target the JN.1-lineage XFG variant.[22] It approved updated Spikevax and mNEXSPIKE on 27 August 2026.[21] Eligibility stayed as narrowed in 2025: everyone 65 and older, plus younger people with at least one high-risk condition, from 6 months for Spikevax and 12 years for mNEXSPIKE.[23]

    Pipeline

    • Cancer. With Merck, Moderna develops intismeran-autogene, a personalised neoantigen therapy. In August 2026 it met its primary endpoint in the phase 3 INTerpath-001 melanoma trial.[3]
    • Flu/COVID combination. As of July 2026, mRNA-1083 was under review in Japan, Canada and Australia. Moderna was awaiting FDA guidance on a US resubmission.[24]
    • Norovirus. mRNA-1403 did not meet the criteria for early success at a phase 3 interim analysis.[25]
    • Pandemic flu. HHS cancelled US funding for Moderna’s pandemic influenza work in May 2025.[26] CEPI then agreed to fund a phase 3 trial of the H5 candidate mRNA-1018, and Moderna committed 20% of its H5 capacity to low- and middle-income countries.[27]

    Finances

    Moderna reported second-quarter 2026 revenue of $145 million. It held $6.9 billion in cash and investments at 30 June 2026.[4]

    Policy environment

    Moderna operates amid contested US vaccine policy. The FDA narrowed COVID-19 vaccine labels in 2025, and HHS ended BARDA mRNA investments.[28][29] See the US mRNA policy debate. Main competitor BioNTech makes the other first-generation mRNA COVID-19 vaccine.[5]

    Questions readers ask

    What products does Moderna have approved in the US?

    As of August 2026, four products are FDA-approved. They are Spikevax, mRESVIA, mNEXSPIKE and the mRNA flu vaccine mFLUSIVA.[2]

    Why did the FDA first refuse Moderna's flu vaccine application?

    In February 2026 the FDA refused to file it over the choice of comparator vaccine for older adults, not over safety or efficacy concerns. It accepted an amended application about a week later.[13]

    What happened to Moderna's US bird-flu vaccine funding?

    HHS cancelled federal funding for Moderna's pandemic influenza vaccine work in May 2025. In December 2025 CEPI agreed to provide up to $54.3 million for a phase 3 trial of the H5 candidate.[26][27]

    When were mRESVIA and mNEXSPIKE approved?

    The FDA approved the RSV vaccine mRESVIA effective 31 May 2024 for adults 60 and older, and extended it to higher-risk adults aged 18-59 on 12 June 2025. It approved the COVID-19 vaccine mNEXSPIKE on 30 May 2025.[16][17][19]

    Are Moderna's COVID-19 vaccines updated for 2026-2027?

    Yes. On 27 August 2026 the FDA approved XFG-targeted 2026-2027 formulas of Spikevax and mNEXSPIKE, with eligibility still limited to people 65 and older and younger people with high-risk conditions.[21][23]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      Moderna is headquartered in Cambridge, Massachusetts, and describes its mission as delivering impact through mRNA medicines. confirmedas of 2026-10-10

    2. [2]

      In August 2026 the FDA approved Moderna's mFLUSIVA (mRNA-1010) for adults 50 and older, the first mRNA-based influenza vaccine and Moderna's fourth FDA-approved product after Spikevax, mRESVIA and mNEXSPIKE. confirmedas of 2026-08-06

    3. [3]

      On 19 August 2026 Merck and Moderna reported that the phase 3 INTerpath-001 trial of intismeran autogene plus pembrolizumab met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma. confirmedas of 2026-08-19

    4. [4]

      Moderna reported second-quarter 2026 revenue of $145 million and cash and investments of $6.9 billion at 30 June 2026. confirmedas of 2026-07-31

    5. [5]

      The first authorized mRNA COVID-19 vaccines, Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273, both encode the SARS-CoV-2 spike protein and are formulated in lipid nanoparticles. confirmedas of 2023-03-01

    6. [6]

      Chemically modified nucleosides in synthetic mRNA partially suppress recognition of double-stranded RNA and reduce type I interferon signalling, an innate immune alarm response. confirmedas of 2018-01-12

    7. [7]

      Lipid nanoparticles used for mRNA delivery usually contain four components, an ionizable lipid, a PEG-linked lipid, cholesterol and a phospholipid (helper lipid). confirmedas of 2023-03-01

    8. [8]

      mRNA is a non-infectious, non-integrating platform that is degraded by normal cellular processes. confirmedas of 2018-01-12

    9. [9]

      mRNA vaccines can potentially be manufactured rapidly, cheaply and at scale, mainly because in vitro transcription reactions give high yields. confirmedas of 2018-01-12

    10. [10]

      The phase 3 trial behind mFLUSIVA enrolled 40,805 adults aged 50 and older in 11 countries and compared it with a licensed standard-dose flu vaccine. confirmedas of 2026-08-06

    11. [11]

      mFLUSIVA showed about 26.6% relative vaccine efficacy against confirmed influenza-like illness compared with a standard-dose flu vaccine. confirmedas of 2026-08-06

    12. [12]

      The FDA granted mFLUSIVA standard approval for ages 50-64 and accelerated approval for 65 and older, the latter conditional on a confirmatory trial. confirmedas of 2026-08-06

    13. [13]

      In February 2026 the FDA first refused to file Moderna's flu vaccine application, citing the choice of comparator vaccine for older adults rather than safety or efficacy concerns, then accepted an amended application about a week later. confirmedas of 2026-02-18

    14. [14]

      The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended mFLUSIVA for adults 50 and older before approval. confirmedas of 2026-08-06

    15. [15]

      The Infectious Diseases Society of America welcomed the mFLUSIVA approval, saying the mRNA platform allows streamlined development and rapid responses to viral mutations. confirmedas of 2026-08-06

    16. [16]

      The FDA approved Moderna's RSV vaccine mRESVIA effective 31 May 2024 for adults 60 and older. confirmedas of 2024-05-31

    17. [17]

      On 12 June 2025 the FDA extended mRESVIA's approval to adults aged 18-59 who are at increased risk of RSV lower respiratory tract disease. confirmedas of 2025-06-12

    18. [18]

      In August 2026 the FDA approved an mRESVIA label update, based on an interim analysis of a pediatric study, describing an imbalance in severe or hospitalized RSV lower respiratory tract disease among infants vaccinated at 5-7 months of age who were RSV-seronegative at baseline; the vaccine's approved uses remain limited to adults. confirmedas of 2026-08-07

    19. [19]

      On 30 May 2025 the FDA approved Moderna's next-generation COVID-19 vaccine mNEXSPIKE for previously vaccinated people aged 65 and older, or aged 12-64 with at least one condition that puts them at high risk of severe COVID-19. confirmedas of 2025-05-30

    20. [20]

      mNEXSPIKE encodes only two parts of the coronavirus spike protein, the N-terminal domain and the receptor-binding domain, at a 10-microgram dose in its 2026-2027 formula. confirmedas of 2026-08-28

    21. [21]

      On 27 August 2026 the FDA approved 2026-2027 formula versions of the mRNA vaccines Comirnaty, Spikevax and mNEXSPIKE, which target the XFG variant; Novavax's protein-based Nuvaxovid was also approved for the season. confirmedas of 2026-08-27

    22. [22]

      After its vaccine advisory committee met on 28 May 2026, the FDA advised manufacturers that 2026-2027 COVID-19 vaccines for the US should be monovalent vaccines targeting the JN.1-lineage XFG variant. confirmedas of 2026-05-29

    23. [23]

      The 2026-2027 approvals kept the narrower US eligibility set in 2025, covering everyone 65 and older plus younger people with at least one high-risk condition, from age 5 for Comirnaty, 6 months for Spikevax and 12 for mNEXSPIKE. confirmedas of 2026-08-28

    24. [24]

      As of July 2026 Moderna's combined flu and COVID-19 vaccine mRNA-1083 was under regulatory review in Japan, Canada and Australia, while the company awaited FDA guidance on a US resubmission. confirmedas of 2026-07-31

    25. [25]

      Moderna's norovirus vaccine candidate mRNA-1403 did not meet the statistical criteria for early success at a phase 3 interim analysis, the company reported in July 2026. confirmedas of 2026-07-31

    26. [26]

      In May 2025 the US Department of Health and Human Services cancelled federal funding for Moderna's pandemic influenza vaccine development, including its H5 bird-flu candidate. confirmedas of 2025-12-18

    27. [27]

      In December 2025 CEPI agreed to provide up to $54.3 million for a phase 3 trial of Moderna's H5 pandemic influenza vaccine candidate mRNA-1018, and Moderna committed 20% of its H5 vaccine capacity to low- and middle-income countries at affordable prices. confirmedas of 2025-12-18

    28. [28]

      In August 2025 the FDA limited the approved use of Pfizer-BioNTech's Comirnaty to people 65 and older and younger people with at least one condition that puts them at high risk of severe COVID-19. confirmedas of 2025-08-25

    29. [29]

      In August 2025 HHS announced that BARDA was terminating 22 mRNA vaccine development investments worth about $500 million. confirmedas of 2025-08-08

    Revision history (2)
    1. Page created.
    2. Added dated approvals for mRESVIA and mNEXSPIKE, the August 2026 mRESVIA label update and the 2026-2027 COVID-19 vaccine approvals.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "Moderna." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/moderna

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    Intismeran autogene Co-developer ofCEPI Funded for H5 phase 3 byBioNTech Competitor
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