Moderna's updated COVID vaccine now awaits FDA authorization

Moderna is preparing to roll out updated vaccines to arm patients with immunity from the most recent COVID variant. 

The biotechnology giant announced on June 22 the submission of its regulatory application to the U.S. Food and Drug Administration for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 variant. Moderna is the first vaccine manufacturer to do so following the FDA’s Vaccines and Related Biological Products Advisory Committee meeting that was held earlier in June. In that meeting, the advisory committee recommended that COVID vaccines be updated to a monovalent XBB.1.5 composition. 

Moderna was the only company that submitted preliminary clinical data comparing human immune responses to XBB variants following monovalent and bivalent vaccines prior to the committee meeting. 

Moderna CEO Stéphane Bancel cited the agility of Moderna’s mRNA platform as the force behind the company’s ability to produce a vaccine that targets XBB variants with “speed and clinical vigor.” 

"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,” Bancel said in the announcement. “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.” 

In clinical trials, the most commonly reported local adverse event related to the updated vaccine was injection site pain, while the most common systemic events were headache, fatigue, myalgia and chills—similar to what has been previously reported with other COVID vaccines. 

Moderna has submitted additional applications to regulators globally as the company prepares to roll out the updated vaccine this coming fall.