Moderna receives USFDA nod for updated COVID vaccine

"COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," said Stéphane Bancel, CEO of Moderna. "We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."

In June 2023, the U.S. FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023 - 2024 vaccination season. At the June VRBPAC, Moderna presented clinical data showing that its updated vaccine resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16. In August, Moderna announced additional clinical trial data which showed the company's updated COVID-19 vaccine elicited an immune response in humans against EG.5 and FL.1.5.1, currently the dominant variants in the United States. Last week, the company shared additional clinical trial data confirming that the updated vaccine also elicited a human immune response against BA.2.86.

Outside the U.S., regulatory applications for Moderna's updated COVID-19 vaccine are under review by other regulatory agencies with decisions anticipated in the coming weeks.