Moderna has initiated a Phase I first-in-human study of mRNA-1469, an mRNA vaccine against Bundibugyo ebolavirus, in roughly 80 healthy adults across three Canadian sites, marking the first Ebola mRNA candidate to reach clinical stage for this strain amid a WHO-declared Public Health Emergency of International Concern (PHEIC) with over 3,000 confirmed cases and 1,400 deaths.

Separately, the US FDA approved mFLUSIVA (mRNA-1010) for seasonal influenza prevention in adults aged 50 and older, making it the first mRNA influenza vaccine approved in the US and Moderna's fifth globally approved product. The approval rested on a 40,805-participant Phase III trial (NCT06602024) showing acceptable safety and relative vaccine efficacy versus standard-dose inactivated vaccine, with a separate immunogenic bridge study (NCT05827978) in 2,992 adults aged 65 and older supporting accelerated approval in that subgroup pending confirmatory post-marketing data.

Regulatory filings for mRNA-1010 are also under review in the EU, Canada, and Australia, with further submissions planned in 2026, marking Moderna's transition from pandemic-only mRNA use to seasonal and outbreak infectious disease commercialisation.