Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine

Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86
Updated vaccine to be available in pharmacies and care settings across the U.S. in the coming days

CAMBRIDGE, MA / ACCESSWIRE / September 11, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application(sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) 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.