New COVID Vaccines Approved by FDA
- By BSTQ Staff
Updated COVID-19 vaccines from Moderna, Novavax-Sanofi and Pfizer-BioNTech have been approved by the U.S. Food and Drug Administration (FDA). All three vaccines are designed to prevent severe disease caused by the dominant strain, the JN.1 lineage XFG subvariant.
Approval is for adults 65 and older, as well as younger people with one or more chronic conditions that put them at higher risk for severe disease. And, each vaccine approval is slightly different:
• Pfizer’s mRNA vaccine, Comirnity XFG, is approved for adults 65 years and older, and people ages 5 to 64 years old with an underlying condition. Pfizer has already begun distributing vaccines, and they should arrive in pharmacies soon.
• Moderna’s mRNA vaccine, Spikevax, is approved for people age 65 and older, and those 6 months to 64 years old with an underlying condition. Moderna’s new, lower-dose vaccine, mNEXSPIKE, is approved for people age 65 and older, as well as people 12 to 64 years old with an underlying condition.
• Sanofi also has received FDA approval for its COVID-19 vaccine, Nuvaxovid, originally licensed by Novavax, which does not use mRNA technology. Nuvaxovid is approved for adults ages 65 years and older, and people ages 12 years to 64 years who are at high risk for severe COVID-19.
AHIP, an organization that includes most health insurers, has said its members will cover the total cost of vaccines recommended by a Centers for Disease Control and Prevention committee at least until the end of 2027.
References
Szabo, L. FDA Approves New COVID Vaccines. University of Minnesota Center for Infectious Disease Research and Policy, Aug. 28, 2026. Accessed at www.cidrap.umn.edu/covid-19/fda-approves-new-covid-vaccines.