Updated COVID-19 vaccine formulas from Pfizer, Moderna, and Novavax target the circulating XFG variant for older adults and high-risk populations.
RT’s Three Key Takeaways:
- Targeted Variant Protection: The FDA approved updated 2026-2027 COVID-19 vaccine formulas targeting the JN.1-lineage XFG variant from Pfizer-BioNTech, Moderna, and Novavax partners.
- High-Risk Population Focus: The approvals authorize updated shots for adults aged 65 and older, as well as individuals with underlying conditions that increase the risk of severe respiratory illness.
- Multiple Vaccine Platforms Available: Healthcare providers will have access to both mRNA vaccines and a protein-based alternative as clinical facilities prepare for the autumn viral season.
The USFDA has granted regulatory approvals for updated 2026-2027 COVID-19 vaccine formulations from Pfizer/BioNTech, Moderna, and Novavax Partners (Sanofi and Takeda), according to company announcements. The updated formulations align with FDA guidance recommending a monovalent JN.1-lineage XFG subvariant composition to protect against contemporary circulating strains during the fall respiratory illness season.
The regulatory decisions clear updated vaccines for distribution across pharmacies, hospitals, and clinics throughout the US.
Pfizer and BioNTech sBLA Approval
Pfizer and BioNTech announced that the FDA approved their supplemental Biologics License Application (sBLA) for their 2026-2027 COVID-19 formula targeting the XFG variant (Comirnaty XFG; COVID-19 Vaccine, mRNA). The approval covers individuals 65 years of age and older, as well as individuals aged 5 through 64 years who have at least one underlying medical condition that elevates their risk for severe COVID-19 outcomes, according to a news release from Pfizer.
Pfizer reported that the approval was supported by clinical, non-clinical, and real-world evidence confirming the safety and effectiveness of the vaccine, alongside laboratory data showing strong immune responses against currently circulating lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, and PQ.2.8.1. Doses are scheduled to begin shipping immediately across the US, according to the company.
Moderna Clears Spikevax and mNexSpike
Moderna received FDA approvals for the sBLAs of two mRNA vaccines targeting the JN.1-lineage XFG subvariant: Spikevax and mNexSpike, according to a company press release.
Spikevax is approved for all adults aged 65 years and older, as well as individuals aged 6 months through 64 years with at least one underlying condition that places them at high risk for severe outcomes. The company’s newer COVID-19 vaccine, mNEXSPIKE, is approved for adults 65 years and older and individuals aged 12 through 64 years at high risk for severe disease.
“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,” said Stéphane Bancel, chief executive officer of Moderna, in a news release. Moderna stated that its updated products are expected to be available to healthcare providers and patients within days.
Protein-Based Option via Novavax
Novavax announced that its commercial partners, Sanofi and Takeda, received regulatory approvals for the XFG-adapted formulation of Nuvaxovid across major international markets, including the US, the European Union (EU), and Japan.
Unlike mRNA vaccines, Nuvaxovid is a protein-based option created with recombinant nanoparticle technology and Novavax’s Matrix-M adjuvant, according to the company. The vaccine is packaged in pre-filled syringes and stored at standard refrigerated temperatures between 2° and 8°C, which allows healthcare systems to use existing cold chain infrastructure.
“We believe our partners Sanofi and Takeda are well-positioned for this commercial season,” said John C Jacobs, president and chief executive officer of Novavax. Novavax noted that Sanofi is leading commercialization in the US and expanding marketing activities ahead of the seasonal peak.
