New COVID Vaccines Approved by FDA

Updated COVID-19 vaccines from Moderna, Novavax-Sanofi and Pfizer-BioNTech have been approved by the U.S. Food and Drug Administration (FDA). All four 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 years and olderwith 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 and older with an underlying condition.

• Moderna’s mRNA vaccine, mNEXSPIKE, is approved for ages 12 years and older with underlying conditions, and all adults 65 and older.

• Sanofi also has received FDA approval for its protein-based COVID-19 vaccine, Nuvaxovid, originally licensed by Novavax. Nuvaxovid is approved for adults ages 65 years and older, and people ages 12 years and older 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

Healthline. FDA Approves 4 Updated COVID-19 Vaccines for 2026-2027 Season. Accessed at www.healthline.com/health-news/fda-approves-updated-covid-19-vaccines-targeting-xfg-variant#What-are-the-four-approved-COVID-19-vaccines.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.