Moderna Suspends New Late-Stage Vaccine Trials Over U.S. Backlash
Moderna CEO Stephane Bancel said the company will not invest in any new late-stage vaccine trials due to escalating opposition from U.S. officials towards immunizations. The decision may reallocate R&D resources from future vaccine candidates to other mRNA therapies and reshape Moderna’s long-term pipeline strategy.
1. Five-Year Phase IIb Data Show 49% Reduction in Melanoma Recurrence or Death
Moderna and Merck announced that long-term follow-up from their Phase IIb study of intismeran autogene in combination with pembrolizumab in high-risk stage III/IV melanoma patients demonstrated a 49% reduction in the risk of recurrence or death compared with pembrolizumab alone. The trial enrolled 180 patients across 25 sites in North America and Europe, with a median follow-up of 60 months. Five-year recurrence-free survival rose from 45% in the control arm to 67% in the combination arm, while safety data remained consistent with previous reports, showing no new immune-related adverse events beyond those expected with checkpoint inhibition.
2. CEO Signals Shift Away from New Late-Stage Vaccine Trials
In a Bloomberg TV interview at the World Economic Forum in Davos on January 22, 2026, Moderna’s CEO Stephane Bancel said the company will not initiate new late-stage vaccine trials in 2026 due to mounting scrutiny from U.S. health officials and policymakers. Bancel cited increasing regulatory hurdles and political headwinds around novel immunizations as key factors in the decision. He emphasized that Moderna will instead focus R&D spend on oncology and rare disease mRNA programs, reallocating an estimated $200 million that had been earmarked for additional respiratory and pandemic-preparedness studies.
3. Pipeline Reallocation Aims to Accelerate Oncology Programs
Following the strategic pause in vaccine trial investments, Moderna plans to redirect resources toward three late-stage oncology candidates, including personalized mRNA-1893 for skin cancers and two undisclosed solid tumor vaccines. The company estimates this shift will accelerate timelines by six to nine months, potentially bringing a lead candidate into Phase III by late 2026. Moderna’s R&D budget for cancer and rare disease is slated to increase from $1.2 billion in 2025 to $1.5 billion in 2026, reflecting management’s confidence in mRNA’s therapeutic potential beyond infectious diseases.