Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval

Moderna, Inc. (NASDAQ: MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1.

"For four years, Moderna has consistently delivered vaccines that offer protection against COVID-19, and work is well underway to provide a vaccine targeting JN.1," said St�phane Bancel, CEO of Moderna. "Staying up to date with your COVID-19 vaccine remains one of the best ways to protect yourself during the upcoming respiratory illness season."

The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 composition for the 2024-2025 season. This guidance aligns with the recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) and the European Medicines Agency's Emergency Task Force (ETF) on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.

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.

Moderna is submitting data to regulators worldwide to support registration and supply of the 2024-2025 formula of Spikevax in time for the upcoming vaccination season.

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 and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.