Merck and Moderna are preparing to file intismeran autogene, their personalized mRNA melanoma vaccine, for regulatory approval.
Merck and Moderna, joint developers of intismeran
Life Sciences & Medicine Active Updated Oct 16, 2026
Can the technology behind the COVID vaccines fight cancer too?
The expanding reach of mRNA vaccines
Where it stands as of Oct 16, 2026
The FDA approved mFlusiva, Moderna's mRNA seasonal flu vaccine for adults 50 and older, after a trial of nearly 41,000 people found it beat a standard flu shot by 26.6 percent. Merck and Moderna say intismeran, a personalized melanoma vaccine, met its primary endpoints in the first randomized Phase 3 trial of its kind, and they are now preparing to file for approval, with trials already running in lung, kidney and bladder cancer. The full melanoma numbers have not been released, and whether it works against 'cold'
Merck and Moderna's intismeran, a personalized mRNA vaccine built from a patient's own tumor mutations, is the first neoantigen cancer vaccine tested in a randomized Phase 3 trial, aimed at preventing melanoma recurrence after surgery. The stakes are whether a treatment built patient by patient can extend disease-free years and validate mRNA as a platform beyond infectious disease.
The story so far
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Oct 16, 2026 Latest
STAT reported that Merck and Moderna are preparing to file intismeran autogene for approval after August's Phase 3 melanoma result, and that trials are already running in adjuvant lung, kidney and bladder cancer. Moderna's Stephen Hoge said the companies 'have a lot of exploring to do and need to prioritize where we explore', since the vaccine has so far been tested only as an add-on after surgery, where Keytruda works best.
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Aug 20, 2026
Merck and Moderna announced that intismeran, a personalized mRNA melanoma vaccine encoding up to 34 tumor-specific mutations, met its primary endpoints in the first randomized Phase 3 trial of a neoantigen cancer vaccine, improving recurrence-free and distant metastasis-free survival among 1,137 patients when added to Keytruda after surgery, though full numbers are still pending.
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Aug 9, 2026
The FDA's approval of mFlusiva came exactly one year after Health Secretary Robert F. Kennedy Jr. canceled 22 mRNA vaccine projects on August 5, 2025, after nine expert advisers he appointed voted unanimously that the vaccine's benefits outweigh its risks. Vox reported the 2024-25 flu season caused 51 million illnesses, 710,000 hospitalizations and 45,000 deaths in the US, more than car crashes that year, with infection carrying about six times the normal heart attack risk in the following week.
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Aug 7, 2026
The FDA approved mFlusiva, Moderna's mRNA seasonal flu vaccine for adults 50 and older, after a trial of nearly 41,000 people across 11 countries found it beat a standard flu shot by 26.6 percent overall and 27.4 percent in people 65 and older. The approval came a year after Health Secretary Robert F. Kennedy Jr. canceled 22 mRNA vaccine projects worth about 500 million dollars, and followed FDA official Vinay Prasad initially refusing to review the file before reversing course and leaving the agency in April.
On the record
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