Recently, Moderna, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine was also received for individuals six months through 11 years of age. Moderna’s updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals six months of age and older. With the U.S. FDA’s decision, Moderna will begin shipping doses to vaccination sites nationwide, with updated vaccines expected to be available in the coming days.
“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season,” said Stéphane Bancel, CEO of Moderna. “We appreciate the FDA’s timely review and encourage individuals who intend to get their flu shot also to get their updated COVID-19 vaccine simultaneously.”
In June 2023, the U.S. FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023 – 2024 vaccination season. At the June VRBPAC, Moderna presented clinical data showing that its updated vaccine resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16. In August, Moderna announced additional clinical trial data, which showed the company’s updated COVID-19 vaccine elicited an immune response in humans against EG.5 and FL.1.5.1, currently the dominant variants in the United States. Last week, the company shared additional clinical trial data confirming that the updated vaccine elicited a human immune response against BA.2.86.
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, consistent with previous Spikevax formulations. COVID is on the rise again, and while it’s impossible to know what the fall and winter season may hold in terms of COVID-19 and other respiratory viruses – many are speculating a “tripledemic” of COVID, flu and RSV – vaccines should remain top of mind. With that said, as routine as it is to get a flu shot, COVID-19 vaccinations should be considered in the same vein.
Here are four things to know about the new vaccine as you look to not only protect yourself but your community and loved ones:
What age group is this vaccine approved for?
The updated COVID-19 vaccine is approved for ages 12 and above, and Emergency Use Authorization was received for individuals six months through 11 years of age. Individuals interested in the updated monovalent vaccine should speak to their healthcare providers about receiving the vaccine.
What data is the FDA approval based on?
The submission is based on guidance from the United States. FDA, which advised that COVID-19 vaccines should be updated to a monovalent composition. This aligns with recommendations from other regulators and global public health agencies.
When will the vaccine be available?
Moderna will begin shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days.
Why is it important to get vaccinated against COVID-19 this year?
COVID-19 remains a global public health threat, representing the third leading cause of death in the United States and the fifth leading cause of death globally. Regular vaccination continues to reduce the risk of contracting COVID-19, protect against serious illness and death, reduce healthcare costs, and reduce the risk of emerging variants.
Outside the United States., regulatory applications for Moderna’s updated COVID-19 vaccine are under review by other regulatory agencies, with decisions anticipated in the coming weeks.