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US FDA approves updated COVID vaccines targeting XFG variant for 2026-27 season

Created at 27 Aug · 9:51 PM1 source↑ Market-relevant
IN SHORT

The U.S. Food and Drug Administration has approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech for the 2026-27 immunization season. The vaccines will target the XFG variant, a subvariant of the JN.1 lineage.

Key Numbers

2026-27immunization season for updated COVID vaccines
JN.1lineage of the XFG variant
LP.8.1variant targeted for 2025-26 season
2.3 millionoutpatient visits last year due to COVID-19
250,000hospitalizations last year due to COVID-19

Who's Involved

U.S. Food and Drug Administration (FDA)
Approved updated COVID-19 vaccines for the 2026-27 season
Moderna, Inc.
Manufacturer of Spikevax and mNEXSPIKE COVID-19 vaccines
Pfizer Inc. and BioNTech SE
Manufacturers of Comirnaty XFG COVID-19 vaccine
Novavax-Sanofi
Manufacturer of a protein-based COVID-19 vaccine
Stéphane Bancel
CEO of Moderna
US FDA approves updated COVID vaccines targeting XFG variant for 2026-27 season

↳ Why This Matters

The FDA's approval of updated COVID-19 vaccines ensures that the public has access to the latest protection against circulating strains of the virus for the upcoming respiratory season, particularly for high-risk populations.

Key facts

  • The FDA approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech.
  • The approved vaccines will target the XFG variant, a subvariant of the JN.1 lineage.
  • Pfizer-BioNTech's Comirnaty XFG vaccine is approved for adults 65+ and individuals 5-64 with underlying conditions.
  • Moderna's Spikevax is approved for individuals 6 months-64 years with underlying conditions and adults 65+.
  • Moderna's mNEXSPIKE is approved for individuals 12-64 years with underlying conditions and adults 65+.
  • Updated vaccines are shipping nationwide for the 2026-27 immunization season.

The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech for the upcoming 2026-27 immunization season. The advisory panel had previously recommended targeting the XFG variant, a subvariant of the JN.1 lineage, which is now incorporated into the new vaccine formulations.

Pfizer and BioNTech's mRNA vaccine, Comirnaty XFG, has been approved for adults aged 65 and older, as well as individuals aged 5 through 64 with underlying health conditions that increase their risk for severe COVID-19 outcomes. Moderna's Spikevax vaccine is approved for individuals aged 6 months through 64 years with at least one underlying condition, and all adults 65 and older. Moderna's latest vaccine, mNEXSPIKE, is approved for individuals aged 12 through 64 years with underlying conditions and all adults 65 and older.

These updated vaccines are designed to provide protection against currently circulating SARS-CoV-2 strains. Shipping of the updated vaccines has begun nationwide, with doses expected to be available in pharmacies, hospitals, and clinics within days. For the previous 2025-26 season, the FDA had recommended targeting the LP.8.1 subvariant of the JN.1 strain.

Frequently asked questions

The updated COVID-19 vaccines target the XFG variant, which is a subvariant of the JN.1 lineage.

Moderna, Novavax-Sanofi, and Pfizer-BioNTech have had their updated COVID-19 vaccines approved.

Shipping has begun, and the vaccines are expected to be available nationwide within days for the 2026-27 immunization season.

For the 2025-26 season, the FDA had recommended COVID shots target LP.8.1, a subvariant of the JN.1 strain.

What Happens Next

01Updated vaccines are expected to be available in pharmacies, hospitals, and clinics within days.

How It Developed

The U.S. FDA approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech.
The advisory panel recommended targeting the dominant XFG variant for the 2026-27 season.
Pfizer and BioNTech's Comirnaty XFG vaccine was approved for adults 65 and older and individuals 5-64 with underlying conditions.
Moderna's Spikevax and mNEXSPIKE vaccines were approved for specific age and risk groups.
Updated vaccines begin shipping nationwide for the upcoming respiratory season.

Sources

T1
US FDA approves updated COVID vaccines for 2026-27 seasonReuters
T2
COVID-19 Vaccines (2026-2027 Formula) for Use in the United States ...fda.gov
T2
Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccinesnewswire.com
T2
FDA Approves XFG-Adapted COVID-19 Vaccine, mRNA for the 2026-2027 Seasonpharmacytimes.com

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