Moderna announces FDA approval for updated COVID-19 vaccine

Moderna announced the U.S. Food and Drug Administration has approved the supplemental Biologics License Application, or sBLA, for Spikevax for ages 12 years and above. Emergency Use Authorization for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age. Moderna’s updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA’s decision, Moderna will begin shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days. “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. 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,” said Stephane Bancel, CEO of Moderna.