The Food and Drug Administration has approved a first-of-its-kind flu vaccine made with messenger RNA technology, enabling its developer, Moderna, to complete a dramatic regulatory turnaround.
The agency on Wednesday approved mFlusiva, previously known as mRNA-1010, for use against seasonal influenza in all adults at least 50 years of age. The shot’s clearance in those 65 or older was handed out under an “accelerated” approval that’s contingent on results from a postmarketing study. Moderna previously disclosed that it’s already aligned with regulators on the framework of that trial, which will take place over the course of two flu seasons.
"Flu remains a significant public health challenge, and mFlusiva provides an important new option for America's seniors,” said Moderna CEO Stéphane Bancel, in a statement. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
Like the rest of Moderna’s pipeline, mFlusiva is built on mRNA technology capable of being weaponized against emerging pathogens more quickly than traditional vaccines. That speed advantage helped Moderna bring one of the first COVID-19 vaccines to market during the pandemic, and made Moderna a household name.
