Moderna, Inc. announced the FDA approval of the supplemental Biologics License Application for Spikevax for individuals aged 12 years and older. Emergency Use Authorization for the Moderna COVID-19 vaccine was also received for individuals aged 6 months through 11 years. 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 aged 6 months and older.

Stéphane Bancel, CEO of Moderna, stated, “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.”

In June 2023, the FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023–2024 vaccination season. Moderna presented clinical data at the June Vaccines and Related Biological Products Advisory Products Committee, demonstrating that its updated vaccine resulted in strong immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16.

In August 2023, Moderna announced additional clinical trial data that established the company’s updated COVID-19 vaccine triggered an immune response in humans against EG.5 and FL.1.5.1—currently the dominant variants in the United States. In September 2023, Moderna shared additional clinical trial data confirming that the updated vaccine also triggered a human immune response against BA.2.86.

The most common solicited local adverse event for Moderna’s updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia, and chills, which aligns with reported adverse drug reactions with previous formulations of Spikevax.

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

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