The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Novavax that specifically target the LP.8.1 sublineage of SARS-CoV-2. The approvals apply to adults 65 and older, as well as individuals ages 5 through 64 with at least one underlying condition that places them at high risk for severe COVID-19.
The decision, announced this week, clears the way for distribution of the new vaccines ahead of the upcoming respiratory season. Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax and mNEXSPIKE, and Novavax’s Nuvaxoid have all been reformulated to address LP.8.1, a subvariant now representing a significant share of circulating strains in the United States.
New Formulas Targeting Emerging Strains
Pfizer-BioNTech’s supplemental biologics license application (sBLA) was supported by preclinical data showing the LP.8.1-adapted vaccine’s effectiveness against several sublineages, including NB.1.8.1 and XFG, when compared with previous vaccine versions. The companies stated that the updated vaccine maintained a strong safety profile and demonstrated robust immune responses in trial participants.
The FDA’s endorsement aligns with its June 2025 guidance recommending that COVID-19 vaccines for the upcoming season be monovalent JN.1-lineage-based and specifically target LP.8.1. Public health experts say this adjustment is critical as the virus continues to evolve, with sublineages like LP.8.1 showing increased transmissibility.
Pfizer and BioNTech indicated that doses of Comirnaty are ready for shipment and should be available in pharmacies and health care facilities nationwide in time for fall vaccination campaigns.
Moderna and Novavax Approvals
The FDA’s move brings Moderna and Novavax into alignment with Pfizer-BioNTech in targeting LP.8.1. Moderna’s mRNA-1283 COVID-19 Vaccines , branded mNEXSPIKE, was first approved in June 2025 for older adults and high-risk individuals ages 12 through 64. Its more established Spikevax product also received approval for younger children at elevated risk of severe illness.
Novavax’s Nuvaxoid, a protein-based vaccine that differs from the mRNA platforms of Pfizer and Moderna, was approved in May 2025 under the same high-risk age categories. Public health officials note that the availability of a protein-based option gives patients with concerns about mRNA vaccines another choice for protection.
With this week’s approvals, all three vaccines are updated to target the same LP.8.1 variant, providing consistent protection strategies across platforms.
FDA’s Public Health Strategy
The decisions follow the framework outlined by FDA Commissioner Martin A. Makary, MD, MPH, who emphasized prioritizing older adults and high-risk populations in future COVID-19 vaccine recommendations. Writing in the New England Journal of Medicine earlier this year, Makary underscored that younger, healthier individuals should be evaluated through additional randomized trials before broad vaccine approvals are issued.
It remains unclear whether Pfizer-BioNTech has been asked to conduct further studies in healthy populations under age 65, though the companies reported having substantial clinical data supporting use in children ages 5 to 11.
The FDA’s actions underscore its strategy of seasonal updates for COVID-19 vaccines, similar to how flu shots are adjusted annually. By ensuring that approved vaccines align with circulating variants, regulators aim to maintain strong protection against hospitalization and death, especially among the most vulnerable.
Looking Ahead
With Comirnaty, Spikevax, mNEXSPIKE, and Nuvaxoid now approved in updated forms, distribution is expected to ramp up ahead of the fall and winter seasons, when respiratory infections typically surge. Health officials are urging eligible groups—older adults and those with underlying conditions, to plan for vaccination as soon as the doses become available.
Pharmacists and clinicians say the availability of multiple updated vaccines should prevent supply shortages and provide flexibility for patients with different medical needs.
“Each approval represents a critical step forward in protecting those at highest risk from the evolving virus,” the FDA said in a statement. “As SARS-CoV-2 continues to adapt, so must our public health tools.”
Also Read :- American Academy of Pediatrics Issues Updated Covid-19 Vaccine Guidance for Children
