FDA Approves Multiple COVID-19 Vaccines With Protection Against XFG variant

Late yesterday, the FDA approved multiple COVID-19 vaccines, all with protections against the XFG variant for the 2026-2027 season. This gives clinicians options ahead of the fall respiratory virus season. Pfizer and BioNTech's Comirnaty XFG, Moderna's Spikevax and mNEXSPIKE, and Novavax's partner-commercialized Nuvaxovid have each received regulatory clearance targeting the XFG variant or its JN1-lineage subvariants, following FDA guidance identifying this composition as the preferred match for currently circulating SARS-CoV-2 strains.^1-3

The approvals span mRNA and protein-based platforms, with indications concentrated among older adults and individuals with underlying conditions placing them at high risk for severe outcomes, and shipping already underway or expected within days across all three vaccines.^1-3

Here is a quick review of each of the products.

FDA Approves Pfizer- BioNTech for Comirnaty XFG

FDA approved a supplemental Biologics License Application from Pfizer- BioNTech for Comirnaty XFG, the companies' 2026-2027 COVID-19 vaccine formula targeting the XFG variant.¹ The vaccine is indicated for adults 65 years and older, as well as individuals ages five through 64 years with at least one underlying condition placing them at high risk for severe COVID-19 outcomes.¹

Selection of XFG follows FDA guidance identifying it as the preferred vaccine composition for the United States beginning fall 2026.¹ The approval rests on a cumulative body of evidence already submitted for Comirnaty, spanning clinical, non-clinical, and real-world data, along with manufacturing and quality information.¹

Non-clinical data specific to the XFG-adapted formula showed strong immune responses against XFG and against several other currently circulating SARS-CoV-2 lineages, including XFG11, NB181, PQ17, and PQ281.¹ Pfizer and BioNTech say this breadth of coverage supports protection against contemporary variants beyond XFG itself.

Shipping of the updated vaccine began immediately following approval, with doses expected to reach pharmacies, hospitals, and clinics nationwide within days.¹ The companies say rapid distribution is intended to ensure access ahead of the fall respiratory virus season.

More than five billion doses of Comirnaty have been distributed globally to date.¹ Pfizer and BioNTech describe the vaccine's safety and efficacy profile as favorable, citing extensive real-world evidence alongside clinical, non-clinical, pharmacovigilance, and manufacturing data collected since the original vaccine's authorization.

BioNTech remains the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted formulas in the United States, the European Union, the United Kingdom, and other markets, and holds emergency use authorizations or equivalents elsewhere.

Novavax partners win XFG-adapted Nuvaxovid approvals for 2026-2027

Novavax's commercial partners have secured approvals for an XFG-adapted formulation of Nuvaxovid, the company's protein-based COVID-19 vaccine, ahead of the 2026-2027 vaccination season.² Regulators in the United States, European Union, and Japan have cleared the updated formula, positioning Novavax to earn royalties on partner sales across these markets this season.²

Sanofi and Takeda lead commercialization under separate licensing agreements with Novavax. Sanofi, described as Novavax's largest partner, plans an expanded US marketing push alongside new launches in Germany, Canada, and other international markets.² Takeda commercializes Nuvaxovid in Japan, where the vaccine became the second-most used COVID-19 vaccine during the 2025-2026 season, with delivery volumes and administering sites both increasing year over year.²

"We believe our partners Sanofi and Takeda are well-positioned for this commercial season," John C. Jacobs, president and chief executive officer of Novavax, said in a statement.² Jacobs said the approvals allow Novavax continued royalty eligibility without maintaining its own commercial infrastructure.²

Novavax pointed to results from Sanofi's Phase 4 COMPARE study, a head-to-head comparison of Nuvaxovid against a next-generation mRNA COVID-19 vaccine, as evidence supporting Nuvaxovid's tolerability profile.²The company frames this profile as an important factor for clinicians and patients weighing vaccine options, particularly given the continued burden of COVID-19 among older adults and other high-risk groups.²

Nuvaxovid is manufactured using Novavax's recombinant nanoparticle technology, generating a non-infectious spike protein antigen paired with the company's Matrix-M adjuvant to broaden immune response.² The vaccine ships in pre-filled syringes and is stored between 2°C and 8°C, allowing distribution through existing vaccine supply and cold chain infrastructure.²

One thing to note. This is the only immunization product of the three that is not derived from mRNA technology.

Moderna receives FDA approval for updated 2026-2027 COVID-19 vaccines

The FDA has approved supplemental Biologics License Applications for Moderna's 2026-2027 formulas of Spikevax and mNEXSPIKE, both updated to contain the JN1-lineage XFG subvariant of SARS-CoV-2.³ The approvals cover two separate COVID-19 vaccines under Moderna's portfolio, each with distinct age and risk-based indications.

The updated Spikevax formula is approved for individuals six months through 64 years of age with at least one underlying condition placing them at high risk for severe COVID-19 outcomes, along with all adults 65 years of age and older.³ mNEXSPIKE, described by Moderna as its latest COVID-19 vaccine, carries a narrower age range, approved for individuals 12 through 64 years with a qualifying high-risk condition and all adults 65 and older.³

According to the announcement, the updated composition follows FDA guidance calling for a monovalent JN.1-lineage XFG subvariant formulation for the 2026-2027 season.³ Moderna said its updated vaccines are expected to become available in the coming days following the approval decision.

"COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the US last year alone," Stéphane Bancel, chief executive officer of Moderna, said in a statement. Bancel said the updated vaccines are intended to protect those at highest risk of severe disease heading into the respiratory virus season.³

Beyond the United States, the 2026-2027 Spikevax formula has already received approval from regulators in Europe, South Korea, Singapore, Switzerland, and the United Kingdom, among other countries.³ The updated mNEXSPIKE formula has separately been approved in Japan.³ Moderna said additional regulatory applications remain under review in other markets ahead of the coming season.

References

1.Pfizer and BioNTech receive US FDA approval for XFG-adapted COVID-19 vaccine. Pfizer Inc, BioNTech SE. Pfizer news release. August 27, 2026. Accessed August 27, 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-xfg-adapted
2. Novavax's partnership strategy continues to deliver with XFG-adapted Nuvaxovid approvals in the U.S., EU and Japan for 2026-2027 vaccination season. Novavax press release. August 28, 2026. Accessed August 28, 2026. https://ir.novavax.com/press-releases
3.Moderna receives US FDA approval for updated 2026-2027 COVID-19 vaccines. News release. Moderna press release. August 27, 2026. Accessed August 28, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=5391658462991287&symbol=MRNA