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    mRNA vaccines and RNA medicines tracker

    This tracker follows the mRNA and RNA-medicine frontier. Since 2025 the main milestones have been the first mRNA flu vaccine, the first positive phase 3 trial of a personalised mRNA cancer therapy and RNAi's growth in heart disease.[1][2][3] Over the same period, US agencies narrowed COVID-19 vaccine labels and ended BARDA mRNA investments, and a federal court stayed the reconstituted ACIP's appointments and votes.[4][5][6]

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

    What we know

    • The FDA approved the first mRNA flu vaccine, Moderna's mFLUSIVA, for adults 50+ in August 2026[1]
    • Intismeran plus pembrolizumab met its primary endpoint in the phase 3 INTerpath-001 melanoma trial[2]
    • A self-amplifying mRNA COVID-19 vaccine (Kostaive) is authorized in the EU[38]
    • Alnylam's Amvuttra passed $1 billion in quarterly sales in Q2 2026[8]
    • US COVID-19 mRNA vaccine labels are limited to people 65+ and higher-risk younger people[4]
    • XFG-targeted 2026-2027 COVID-19 vaccines were approved on 27 August 2026 with the same narrower eligibility[11]
    • State bills to ban mRNA vaccines in Montana (2025) and against mRNA vaccine requirements in South Dakota (2026) failed[27]
    • HHS cancelled federal funding for Moderna's pandemic flu work in May 2025[39]
    • CEPI agreed in December 2025 to fund a phase 3 trial of Moderna's H5 pandemic flu vaccine candidate[19]
    • ACIP appointments and votes since June 2025 are stayed while the government appeals[9]
    • The WHO Pandemic Agreement cannot open for signature until its PABS annex is agreed[40]

    What we don't know yet

    • Full INTerpath-001 effect sizes, and whether and when Merck and Moderna file for approval
    • How the First Circuit will rule in AAP v. Kennedy, and what that means for federal vaccine recommendations
    • Results of the FDA-required placebo-controlled COVID-19 vaccine trial in healthy adults aged 50-64
    • Whether the FDA will accept a US filing for Moderna's flu/COVID combination vaccine mRNA-1083
    • Whether the PABS annex is agreed at a 2026 special session or the May 2027 World Health Assembly
    • Whether self-amplifying RNA shows clinical advantages over conventional mRNA in comparative trials
    • Whether federal agencies will issue a recommendation for the 2026-2027 COVID-19 vaccines while ACIP's votes are stayed
    • Whether more states will pass mRNA-specific restrictions, or more will change laws to rely less on ACIP
    Story status

    Story status

    State
    developing
    Started
    2018-08-10
    Timeline entries
    26
    Last entry

    Timeline data (JSON)

    Dated milestones in mRNA vaccines, RNA drugs and related policy. New to the field? Start with the crash course.

    Where things stand (October 2026)

    mRNA has moved beyond COVID-19. The FDA approved Moderna’s mFLUSIVA flu vaccine for adults 50 and older in August 2026.[1] Weeks later, intismeran-autogene gave the first positive late-stage result for an mRNA cancer treatment.[7] On the drug side, Alnylam‘s Amvuttra passed $1 billion in quarterly sales.[8] In US policy, the reconstituted ACIP’s votes are stayed while the government’s appeal is pending.[9] The FDA approved XFG-targeted 2026-2027 COVID-19 vaccines on 27 August 2026, keeping eligibility limited to people 65 and older and higher-risk younger people.[10][11]

    Key numbers

    • 40,805 adults in the phase 3 trial behind mFLUSIVA, which showed about 26.6% relative efficacy against a standard-dose flu vaccine.[12][13]
    • 1,137 melanoma patients randomized in INTerpath-001.[14]
    • Up to 34 neoantigens encoded in each personalised intismeran dose.[15]
    • XFG, the JN.1-lineage variant chosen for 2026-2027 COVID-19 vaccines.[16]
    • 10 micrograms of mRNA per mNEXSPIKE dose, which encodes only two parts of the spike protein.[17]
    • At least seven states where bills to ban or limit mRNA vaccines were introduced in 2025.[18]
    • 22 BARDA mRNA investments, worth about $500 million, ended in August 2025.[5]
    • Up to $54.3 million from CEPI for the phase 3 trial of Moderna’s H5 vaccine.[19]
    • 16 antisense drugs approved by the FDA and EMA as of February 2026.[20]

    Setbacks and policy changes

    Progress has not been uniform. Moderna’s norovirus vaccine missed an early-success bar at a phase 3 interim analysis.[21] The FDA first refused to file Moderna’s flu vaccine application over its comparator, then accepted an amended application about a week later.[22] Alnylam trimmed its 2026 guidance despite record sales.[23]

    In US policy, HHS ended 22 BARDA mRNA investments, and the FDA narrowed COVID-19 vaccine labels.[5][4] HHS and its critics disagree about these changes.[24][25] Both sides’ arguments are set out in the policy debate.

    States have also acted. Montana’s 2025 bill to ban mRNA vaccines for humans did not pass.[26] In February 2026 the South Dakota House rejected a bill against requirements for mRNA and other “genetic-based” vaccines.[27] Meanwhile Maryland and at least seven other states enacted laws in 2026 that change ACIP’s role in state vaccine policy.[28][29]

    On the safety side, an August 2026 label update for Moderna’s RSV vaccine mRESVIA describes an imbalance in severe RSV disease among some vaccinated infants in a pediatric study. The vaccine is approved only for adults.[30]

    What to watch next

    • INTerpath-001 full data and filings. Merck and Moderna said the data would go to a medical meeting and to regulators.[31]
    • AAP v. Kennedy appeal. The First Circuit’s decision, which could itself be appealed, will bear on whether the reconstituted ACIP’s appointments and votes stand.[9][32]
    • Combination vaccines. Moderna’s flu/COVID combination mRNA-1083 was under review in Japan, Canada and Australia, pending FDA guidance on a US resubmission.[33]
    • mFLUSIVA confirmatory trial. Approval for adults 65 and older is accelerated and depends on a postmarketing trial.[34]
    • Pandemic preparedness. The PABS annex negotiations, Moderna’s H5 phase 3 and CEPI’s $2.5 billion fundraising for 2027-2031.[35][19][36]
    • RNAi pipeline. Alnylam’s ZENITH phase 3 of zilebesiran and its mivelsiran Alzheimer’s trials.[37]

    How this tracker is maintained

    • Entries come from official feeds (FDA, WHO, EMA and journals) listed for this field.
    • Each entry is tagged confirmed, reported, disputed or unknown.
    • Reported items rely on press coverage not yet confirmed by primary documents.

    This page describes evidence and regulatory status. It is not medical advice.

    Timeline

    25 confirmed1 reported

    1. reported

      AAP v. Kennedy paused in district court pending appeal; ACIP has not met since March[9][51]

    2. confirmed

      FDA approves 2026-2027 COVID-19 vaccines, keeping narrower eligibility[10][11]

    3. confirmed

      Personalised mRNA cancer therapy succeeds in phase 3 melanoma trial[2][7]

    4. confirmed

      mRESVIA label updated with pediatric study findings[30]

    5. confirmed

      FDA approves mFLUSIVA, the first mRNA flu vaccine[1][13]

    6. confirmed

      Moderna's norovirus vaccine misses early-success bar at phase 3 interim[21]

    7. confirmed

      Alnylam's Amvuttra passes $1 billion in a quarter, though the company trims its guidance[8][23]

    8. confirmed

      FDA picks the XFG variant for 2026-2027 COVID-19 vaccines[16]

    9. confirmed

      World Health Assembly extends negotiations on the Pandemic Agreement's PABS annex[35]

    10. confirmed

      Maryland enacts law on state immunization recommendations, one of several states changing ACIP's role[28][29]

    11. confirmed

      Federal court stays ACIP appointments and votes since June 2025[6][50]

    12. confirmed

      South Dakota House rejects bill against requirements for mRNA and other "genetic-based" vaccines[27][49]

    13. confirmed

      FDA accepts Moderna's flu vaccine filing after an initial refusal to file[22]

    14. confirmed

      CEPI funds phase 3 of Moderna's H5 pandemic flu vaccine after US funding ended[19][39]

    15. confirmed

      BioNTech's exchange offer for CureVac meets closing conditions[48]

    16. confirmed

      Reconstituted ACIP moves COVID-19 vaccination to individual decision-making[47]

    17. confirmed

      FDA limits Comirnaty label to 65+ and high-risk people, requires a placebo-controlled trial[4][46]

    18. confirmed

      HHS ends 22 BARDA mRNA vaccine investments worth about $500 million[5][24]

    19. confirmed

      FDA extends mRESVIA to higher-risk adults aged 18-59[45]

    20. confirmed

      FDA approves Moderna's next-generation COVID-19 vaccine mNEXSPIKE[44][17]

    21. confirmed

      Montana bill to ban mRNA vaccines for humans dies[26][18]

    22. confirmed

      FDA approves Amvuttra for ATTR cardiomyopathy[3]

    23. confirmed

      EU authorizes Kostaive, the first self-amplifying mRNA COVID-19 vaccine in the EU[38]

    24. confirmed

      FDA approves Moderna's RSV vaccine mRESVIA for adults 60 and older[43]

    25. confirmed

      Nobel Prize recognises nucleoside-modified mRNA[42]

    26. confirmed

      FDA approves Onpattro, the first RNAi therapeutic[41]

    Questions readers ask

    What are the biggest mRNA milestones of 2026?

    The FDA approved the first mRNA flu vaccine in August 2026. Later that month Merck and Moderna reported that a personalised mRNA cancer therapy met its primary endpoint in a phase 3 melanoma trial.[1][2]

    Is the ACIP currently issuing recommendations?

    A March 2026 court order stayed the reconstituted committee's appointments and votes. As of mid-September 2026 it had not met since, and the government's appeal was pending.[6][51][9]

    Have any mRNA vaccine trials had setbacks recently?

    Moderna's norovirus candidate mRNA-1403 did not meet the statistical criteria for early success at a phase 3 interim analysis, reported in July 2026.[21]

    Which COVID-19 vaccines are approved for 2026-2027 in the US?

    On 27 August 2026 the FDA approved XFG-targeted versions of Comirnaty, Spikevax and mNEXSPIKE, plus Novavax's protein-based vaccine. They are approved for everyone 65 and older and younger people with at least one high-risk condition.[10][11]

    Sources

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

    1. [1]

      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

    2. [2]

      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

    3. [3]

      On 20 March 2025 the FDA approved Alnylam's RNAi drug Amvuttra (vutrisiran) for the cardiomyopathy of transthyretin amyloidosis (ATTR-CM), based on the phase 3 HELIOS-B trial, with quarterly subcutaneous dosing. confirmedas of 2025-03-20

    4. [4]

      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

    5. [5]

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

    6. [6]

      On 16 March 2026 a federal district court in Massachusetts, in American Academy of Pediatrics v. Kennedy, stayed the 13 ACIP appointments and all votes of the reconstituted committee since June 2025. confirmedas of 2026-03-17

    7. [7]

      INTerpath-001 was described as the first positive late-stage result for an mRNA-based cancer treatment and for an individualized neoantigen therapy. confirmedas of 2026-08-19

    8. [8]

      Alnylam reported second-quarter 2026 net product revenues of about $1.17 billion, of which Amvuttra contributed about $1.01 billion. confirmedas of 2026-07-30

    9. [9]

      The federal government appealed the March 2026 ruling to the First Circuit (No. 26-1503), and district court proceedings were paused pending the appeal. confirmedas of 2026-09-30

    10. [10]

      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

    11. [11]

      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

    12. [12]

      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

    13. [13]

      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

    14. [14]

      INTerpath-001 randomized 1,137 patients with completely resected stage IIB-IV melanoma 2:1 to intismeran plus pembrolizumab or pembrolizumab alone. confirmedas of 2026-08-19

    15. [15]

      Each intismeran dose is a synthetic mRNA encoding up to 34 neoantigens chosen from the mutations in that patient's own tumour. confirmedas of 2026-08-19

    16. [16]

      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

    17. [17]

      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

    18. [18]

      In 2025 Republican lawmakers in at least seven states introduced bills to ban or limit mRNA vaccines; some would have imposed criminal penalties, fines or licence revocation on clinicians who gave the shots. confirmedas of 2025-04-14

    19. [19]

      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

    20. [20]

      A February 2026 review counted sixteen antisense oligonucleotide drugs approved by the US FDA and the European Medicines Agency. confirmedas of 2026-02-01

    21. [21]

      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

    22. [22]

      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

    23. [23]

      In July 2026 Alnylam lowered its full-year 2026 TTR net product revenue guidance from $4.4-4.7 billion to $4.2-4.5 billion. confirmedas of 2026-07-30

    24. [24]

      HHS Secretary Robert F. Kennedy Jr. said the BARDA mRNA investments were ended because, in his view, the data show these vaccines fail to protect effectively against upper respiratory infections, and that funding would shift to other platforms such as whole-virus vaccines. confirmedas of 2025-08-08

    25. [25]

      Scientists and industry groups criticised the BARDA cancellations; a former BARDA director called it a blow to national security and the Alliance for mRNA Medicines called it unscientific. confirmedas of 2025-08-08

    26. [26]

      Montana's 2025 bill to ban mRNA vaccines for humans, HB 371, did not pass. confirmedas of 2025-05-20

    27. [27]

      In February 2026 the South Dakota House rejected HB 1163, which would have barred employers and others from requiring "genetic-based vaccinations", defined to include mRNA vaccines. confirmedas of 2026-07-31

    28. [28]

      Maryland's 2026 Vax Act (HB 637), signed by the governor on 14 April 2026, requires the state health secretary to issue recommendations for immunizations based on evidence-based scientific and clinical guidance and changes related insurance coverage requirements. confirmedas of 2026-10-10

    29. [29]

      According to the Association of State and Territorial Health Officials, in 2026 Colorado, Connecticut, Maine, Maryland, New Mexico, Oregon, Vermont and Washington enacted laws modifying ACIP's role in state vaccine policy, several of them requiring insurers to cover vaccines recommended by bodies other than ACIP. reportedas of 2026-05-25

    30. [30]

      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

    31. [31]

      Merck and Moderna said the INTerpath-001 data would be presented at a medical meeting and shared with regulatory authorities; no approval decision had been announced as of the announcement. confirmedas of 2026-08-19

    32. [32]

      In its appeal brief the government argues that ACIP appointments are not reviewable final agency action, that the plaintiffs lack standing, and that the district court wrongly evaluated appointees' credentials one by one. confirmedas of 2026-06-18

    33. [33]

      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

    34. [34]

      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

    35. [35]

      In May 2026 the World Health Assembly extended PABS annex negotiations, with the outcome due at the May 2027 Assembly or a special session in 2026. confirmedas of 2026-05-19

    36. [36]

      CEPI is seeking $2.5 billion in new investment to fund a $3.6 billion strategy for 2027-2031, called CEPI 3.0. confirmedas of 2026-10-10

    37. [37]

      As of July 2026 Alnylam was running the ZENITH phase 3 trial of zilebesiran and phase 2 trials of mivelsiran in Alzheimer's disease. confirmedas of 2026-07-30

    38. [38]

      On 14 February 2025 the European Commission authorized CSL and Arcturus Therapeutics' Kostaive (ARCT-154), the first self-amplifying mRNA COVID-19 vaccine approved in the EU, for adults 18 and older. confirmedas of 2025-02-14

    39. [39]

      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

    40. [40]

      The World Health Assembly adopted the WHO Pandemic Agreement in May 2025, but it cannot open for signature until its annex on pathogen access and benefit sharing (PABS) is finalised. confirmedas of 2026-05-19

    41. [41]

      On 10 August 2018 the FDA approved Alnylam's Onpattro (patisiran), the first approved RNAi therapeutic, which silences the mRNA encoding transthyretin to treat hereditary ATTR amyloidosis polyneuropathy. confirmedas of 2018-08-10

    42. [42]

      The 2023 Nobel Prize in Physiology or Medicine was awarded to Katalin Karikó and Drew Weissman for discoveries on nucleoside base modifications that enabled effective mRNA vaccines against COVID-19. confirmedas of 2023-10-02

    43. [43]

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

    44. [44]

      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

    45. [45]

      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

    46. [46]

      Under the FDA framework, approval for healthy people requires randomized trials measuring clinical outcomes; Pfizer-BioNTech agreed to a saline placebo-controlled trial in healthy adults aged 50-64. confirmedas of 2025-08-25

    47. [47]

      On 19 September 2025 ACIP voted to recommend COVID-19 vaccination based on individual-based (shared clinical) decision-making for people 6 months and older, and rejected a proposal to require prescriptions. confirmedas of 2025-09-19

    48. [48]

      On 3 December 2025 BioNTech announced that about 81.74% of CureVac shares had been tendered in its exchange offer and that all closing conditions for the acquisition had been satisfied. confirmedas of 2025-12-03

    49. [49]

      All six COVID-19-related bills considered in South Dakota's 2026 session failed, including one that would have required blood centres to ask donors whether they had received a COVID-19 or mRNA vaccine and to label their blood accordingly. confirmedas of 2026-07-31

    50. [50]

      In its March 2026 ruling the district court assessed the new ACIP members' credentials, concluding that many lacked the requisite vaccine expertise, and described their appointment as a rushed, informal process. confirmedas of 2026-06-18

    51. [51]

      As of mid-September 2026, the reconstituted ACIP had not met since the March ruling, and medical societies and state health departments were issuing their own vaccination recommendations. reportedas of 2026-09-15

    Revision history (2)
    1. Page created.
    2. Added mRESVIA and mNEXSPIKE approval dates, the mRESVIA label update, the 2026-2027 COVID-19 vaccine strain choice and approvals, and state legislation.

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

    Cite this page

    "mRNA vaccines and RNA medicines tracker." ContentLora, updated Oct 10, 2026. https://contentlora.com/events/vaccines-mrna-tracker

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

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