FDA approves updated COVID vaccines targeting XFG ‘Stratus’ variant

Leilani Chan gets a COVID-19 vaccination by Pfizer by Tamina Nassiri, a licensed practical nurse at Kaiser Permanente Venice Medical Office Building in Culver City Tuesday, Sept. 23, 2025.  (Allen J. Schaben / Los Angeles Times via Getty Images)

The Food and Drug Administration has approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi and Pfizer-BioNTech for the 2026-27 immunization season, the companies said Thursday.

Why you should care:

The updated vaccines are designed to target the XFG variant, following a recommendation from an FDA advisory committee earlier this year. In May, eight of the committee’s nine experts voted in favor of selecting XFG for the upcoming vaccine campaign.

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Dig deeper:

The approved vaccines include Moderna’s mNEXSPIKE and Spikevax, Pfizer-BioNTech’s Comirnaty and Novavax-Sanofi’s protein-based COVID-19 vaccine. Moderna’s and Pfizer-BioNTech’s shots use mRNA technology, while Novavax’s vaccine is protein-based and generally takes longer to manufacture.

All three manufacturers had previously said they expected to have updated doses available in time for the 2026-27 season.

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For the 2025-26 season, the FDA recommended vaccines targeting LP.8.1, a subvariant of the JN.1 strain.

The Centers for Disease Control and Prevention said current variant data is unavailable because of low sequencing submissions.

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What is the XFG variant?

Big picture view:

The latest COVID-19 variant, XFG — also known as Stratus — continues to spread across the United States and is contributing to a summer rise in cases.

Stratus accounted for an estimated 79% of U.S. COVID-19 cases during the week ending Sept. 6, according to the latest data from the U.S. Centers for Disease Control and Prevention. The variant has far surpassed the NB.1.8.1 strain, also known as Nimbus.

What they're saying:

"Stratus has been around in Southeast Asia since January of this year, and came to the United States around the spring," Dr. Magdalena Sobieszczyk, chief of the Division of Infectious Diseases at NewYork-Presbyterian/Columbia University Irving Medical Center, said in information provided by NewYork-Presbyterian.

"We’ve been seeing an uptick since July, predominantly because it’s a variant that can be transmitted easily and people were travelling a lot more, vaccine uptake has not been very high, and now many people are returning to school and their regular routines," she said.

NewYork-Presbyterian said people can help protect themselves and others this fall by getting vaccinated, washing their hands and wearing a mask when appropriate.

The Source: Reuters contributed to this report. Information for this story came from announcements by Moderna, Pfizer-BioNTech and Novavax-Sanofi, FDA advisory committee materials, CDC variant data and guidance from NewYork-Presbyterian. This story was reported from Los Angeles. 

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