Moderna files for FDA authorization of its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815).

"The agility of our mRNA platform has enabled us to update Spikevax, Moderna's COVID-19 vaccine, to target XBB variants with speed and clinical rigor," said Stéphane Bancel, CEO of Moderna. "We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere. In addition, our preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern. Over the past three years, Spikevax has consistently reduced hospitalizations and severe disease outcomes from COVID-19, and we encourage individuals to speak to their healthcare providers about receiving an updated vaccine."

The submission is based on guidance from the FDA, which advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition. This is in alignment with other regulators and global public health agencies who have likewise recommended a monovalent XBB composition. At the recent VRBPAC, Moderna was the only company to submit preliminary clinical data comparing monovalent and bivalent vaccines and showing robust human immune responses across multiple XBB descendent sublineages such as XBB.1.5, XBB.1.16 and XBB.2.3.2.

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.

The company is initiating additional applications to regulators around the globe and is prepared to deliver updated COVID-19 vaccines in time for the fall vaccination season.