Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
August 22, 2024 – Biotechnology, Clinical Trials, Pharmaceutical – Biologics License Application, COVID-19, Moderna, spikevax
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval
22 August 2024 — Massachusetts, US — Moderna, Inc 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.[1] 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.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com.
