Celebrating U.S. FDA Approval of Our Updated COVID-19 Vaccine

I am pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccine for this fall for individuals 12 years of age and older. The updated vaccine composition targets the KP.2 variant, based on guidance from the U.S. FDA.

Emergency Use Authorization (EUA) for Moderna’s COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age.

This approval is timely, as COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. Staying up to date with COVID-19 vaccines remains one of the best ways to help protect yourself from severe illness.

My deepest gratitude goes to the Moderna team for their work to reach this milestone. Our team’s vigilance and proactivity leading to this approval was significant, especially in light of surging infection rates in many U.S. states, rising hospitalization rates over the course of the summer, and the continued threat of Long COVID across age groups.

This approval is another example of how Moderna’s mRNA platform offers a solid foundation to quickly pivot and prioritize the most pressing public health needs as they emerge.

What’s Next

In the U.S., we expect Moderna’s updated vaccine to be in pharmacies and care settings in the coming days. Outside the U.S., regulatory applications for Moderna’s updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies, with decisions anticipated in the coming weeks.

For updated guidance from the CDC, visit this resource and speak to your healthcare provider about receiving an updated COVID-19 vaccine alongside your flu shot this fall.