Moderna flu shot outperforms marketed vaccines in pivotal late-stage trial

Moderna’s mRNA-1010 Moderna flu shot showed 26–27% higher efficacy than current seasonal vaccines in adults 50+, positioning it as a strong contender amid stricter FDA review standards.

Moderna’s mRNA-1010 Moderna flu shot just raised the bar. In a Phase III trial of more than 40,000 participants, it outperformed current seasonal flu vaccines by 26.6% in adults over 50. In the 65-plus group, the edge was even sharper 27.4%. These aren’t minor gains. They’re a clear sign of progress at a moment when vaccine performance is being watched more closely than ever. And for Moderna, the timing couldn’t be better, with the FDA now applying tougher standards to vaccine approvals. The late-stage trial results confirmed superior efficacy across all four flu strains.

Here’s what’s turning heads. In a direct matchup with a licensed comparator widely thought to be GSK’s the Moderna flu shot came out ahead, and not just once. It showed consistent strength across every targeted strain. That’s more than just encouraging. It’s hard clinical proof of concept, drawn from data collected across 11 countries and confirmed by strong immune responses in multiple age groups. With momentum on its side, Moderna is moving toward regulatory discussions for approval. At the same time, it’s actively considering a combined flu and COVID shot filing. The company, after stepping back once before, looks ready to re-engage this time with stronger footing. These results validate the mRNA-1010 efficacy claims, showcasing its real-world potential against seasonal influenza.

For pharma executives and healthcare investors, this isn’t just a set of promising numbers. It’s a signal worth watching. The Moderna flu shot just proved that mRNA platforms aren’t theoretical anymore they can hold their own and even outperform older technologies in a mature, highly competitive category. With FDA vaccine standards growing tougher, Moderna has gained a real edge by delivering comparative clarity, not just potential. Next steps? Think Phase 3B safety tracking, final tweaks to manufacturing scale, and locking down the regulatory path ahead of the 2026 to 2027 flu season. No small lift. And as seasonal influenza vaccine performance takes center stage in global public health strategies, Moderna’s late-stage results could shake up how success is defined and who gets there first. Market entry still depends on the speed of FDA decisions and production readiness. In a space crowded with legacy players and new challengers alike, the Moderna flu shot may be the frontrunner everyone’s about to chase.