Will the FDA approve the personalized mRNA vaccine from Moderna/Merck for melanoma by December 31, 2027?
Current probability of “Yes”: 90%
- Status
- Open
- Category
- Science
- Closing date
- 5 January 2028
- Participants
- 2
VangAI analysis
VangAI estimate: +5% for “Yes”, confidence 85%
- Positive Phase 3 clinical trial results demonstrating significant improvement in recurrence-free survival and distant metastasis-free survival.
- FDA's designation of Breakthrough Therapy status for mRNA-4157/V940 in combination with Keytruda for adjuvant treatment of high-risk melanoma.
- Initiation of Phase 3 V940-001 study by Moderna and Merck aimed at evaluating the efficacy and safety of the mRNA-4157/V940 and Keytruda combination.
- Planned FDA approval submission based on successful Phase 3 results, with potential for accelerated approval.
Like a student with excellent grades and recommendations having a high chance of admission to a prestigious university.
Market rules
The market is resolved as YES if the U.S. Food and Drug Administration (FDA) officially approves (Approval, including accelerated approval) the personalized mRNA vaccine from Moderna (mRNA-4157/V940) in combination with Keytruda (pembrolizumab, Merck) for adjuvant therapy of high-risk melanoma recurrence by 11:59 PM UTC on December 31, 2027. The market is resolved as NO if approval has not been obtained by that date, including a Complete Response Letter, withdrawal of the application, or ongoing review. The submission of a BLA, Priority Review, positive advisory committee opinion, publication of trial results (including the announcement by Moderna and Merck on August 19, 2026, of the success of phase 3) and the stock performance of Moderna are not in themselves grounds for YES.