FDA Approves XFG-Targeted COVID-19 Vaccines From Multiple Companies

The FDA approved updated 2026-2027 COVID-19 vaccines from Pfizer and BioNTech, Moderna, Sanofi, and Takeda within a 2-day span during August 2026, clearing 3 reformulated immunizations that target the XFG variant ahead of the fall respiratory virus season.^1-3

Pfizer and BioNTech announced the FDA approval of the supplemental biologics license application for Comirnaty XFG, and Moderna announced approval of updated Spikevax and mNEXSPIKE formulas.^1,2 Novavax announced that its partners Sanofi and Takeda had received approvals for an XFG-adapted Nuvaxovid formulation in the United States, European Union (EU), and Japan.³

Three Vaccines and The Variant Target

Comirnaty XFG (Comirnaty; COVID-19 vaccine, mRNA) is approved for individuals aged 5 through 64 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and for adults aged 65 years and older.¹

The approval draws on the cumulative body of evidence Pfizer and BioNTech have submitted for Comirnaty, including clinical, nonclinical, and real-world data, along with manufacturing and nonclinical data showing the XFG-adapted vaccine generated strong immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other circulating lineages.¹

Moderna's approval covers 2 vaccines. Spikevax (COVID-19 vaccine, mRNA) is now approved for individuals aged 6 months through 64 years with at least 1 underlying condition that places them at high risk for severe outcomes and for all adults aged 65 years and older.²

mNEXSPIKE (COVID-19 vaccine, mRNA), Moderna's newer vaccine, is approved for individuals aged 12 through 64 years with at least 1 high-risk underlying condition, along with adults aged 65 years and older. Both formulas contain the JN.1-lineage XFG subvariant, matching FDA guidance calling for a monovalent JN.1-lineage XFG subvariant composition this season.²

Novavax's partners Sanofi and Takeda received approvals for an XFG-adapted Nuvaxovid formulation in the US, EU, and Japan for the 2026-2027 season.³

Nuvaxovid is a protein-based vaccine that uses copies of the SARS-CoV-2 spike protein as an antigen, combined with Novavax's Matrix-M adjuvant to broaden the immune response.³

Multiple Products, Different Eligibility Windows

With 3 mRNA-based options now approved alongside 1 protein-based option for the same season, pharmacists filling prescriptions or vaccinating under standing orders need to verify each patient's age and risk status against the specific product's indication rather than treating the vaccines as interchangeable. Spikevax's approval starts at 6 months of age for high-risk patients, and Comirnaty XFG and mNEXSPIKE begin at 5 years and 12 years, respectively, for the same risk-based population.^1,2

"COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the U.S. last year alone," Stéphane Bancel, chief executive officer of Moderna, said in a news release.² "Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season."

How the XFG Variant Was Selected

Vaccine composition decisions like these trace back to the CDC's genomic surveillance program, which tracks the national prevalence of SARS-CoV-2 variants through its National SARS-CoV-2 Strain Surveillance program and sequences contributed by outside laboratories.⁴

The agency issues variant proportion estimates for rolling 4-week periods, publishing updates every Friday, using 2 methods: empiric estimates based on observed sequencing data and Nowcast estimates, which are model-based projections used to cover the most recent period before empiric data becomes available.⁴

A lineage circulating at less than 1% is generally folded into its parent lineage unless a spike-protein mutation with potential implications for vaccine efficacy, transmission, or severity pushes it above that threshold.⁴

REFERENCES

1. Pfizer Inc, BioNTech SE. Pfizer and BioNTech receive U.S. FDA approval for XFG-adapted COVID-19 vaccine. News release. Pfizer Inc. August 27, 2026. Accessed August 31, 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-xfg-adapted

2. Moderna. Moderna receives U.S. FDA approval for updated 2026-2027 COVID-19 vaccines. News release. Moderna. August 27, 2026. Accessed August 31, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=5391658462991287&symbol=MRNA

3. Novavax. Novavax's partnership strategy continues to deliver with XFG-adapted Nuvaxovid approvals in the U.S., EU and Japan for 2026-2027 vaccination season. News release. Novavax. August 28, 2026. Accessed August 31, 2026. https://www.prnewswire.com/news-releases/novavaxs-partnership-strategy-continues-to-deliver-with-xfg-adapted-nuvaxovid-approvals-in-the-us-eu-and-japan-for-2026-2027-vaccination-season-302862775.html

4. Centers for Disease Control and Prevention. Variants and genomic surveillance. CDC.gov. Reviewed August 28, 2025. Accessed August 31, 2026. https://www.cdc.gov/covid/php/variants/variants-and-genomic-surveillance.html