Overview
- The late-stage study, published Wednesday in the New England Journal of Medicine, found roughly 26.6% greater protection versus a standard-dose shot.
- About 2.0% of people who got Moderna’s shot developed symptomatic flu versus about 2.8% with standard vaccines in a trial of more than 40,000 adults aged 50 and older across 301 sites in 11 countries.
- Common reactions such as arm pain, fatigue, headache and muscle aches were more frequent with the mRNA shot, yet most were short-lived and severe adverse events were similar between groups at 2.2% versus 1.9%.
- The FDA rejected the initial filing in February over the comparator for people 65 and older, then accepted an amended application that splits the age groups and requires a post-approval study in older adults.
- If cleared, this would be the first seasonal mRNA flu vaccine in the United States, with parallel reviews underway in the EU, Canada and Australia and potential benefits from faster strain updates using mRNA technology.