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CAMBRIDGE, Mass. — Moderna today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax (2024-2025 formula) for individuals 12 years and above. Emergency Use Authorization (EUA) for the Moderna's COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine targets the KP.2 variant 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's updated vaccine is expected to be available in the coming days.
"COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the U.S. Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," said Stéphane Bancel, CEO of Moderna. "We appreciate the U.S. FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."
The U.S. FDA's decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines. The updated vaccine composition is based on guidance from the U.S. FDA, which states that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2 composition.
All of Moderna's COVID-19 vaccines have been well-tolerated. The most common solicited local adverse event for Moderna's COVID-19 vaccines is injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills.
In other countries, regulators have recommended a vaccine that specifically targets the JN.1 variant; Moderna is simultaneously manufacturing an updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. Additional 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.
“In our second year as a U.S. commercial organization, we have focused on building a robust supply chain, with the goal of getting products out in a timely and efficient manner. In the U.S., we expect Spikevax to be at pharmacies and care settings in the coming days. Our team is fully prepared to deliver on our commitments for the upcoming season,” says David Jimenez, senior vice president and general manager of North America at Moderna.
“Delivering the greatest possible impact to our patients and public health remains our top priority.”
