For the 2025 to 2026 season, approved products are Pfizer-BioNTech’s Comirnaty LP.8.1, Moderna’s Spikevax and mNEXSPIKE, and Novavax’s Nuvaxovid.
Pfizer-BioNTech’s monovalent Comirnaty LP.8.1 was approved for adults aged 65 years and older and for patients aged 5 through 64 years with at least one underlying condition that increases risk for severe COVID-19. Moderna received approvals for two messenger RNA vaccines with risk-based indications: Spikevax for adults aged 65 years and older and for patients aged 6 months through 64 years at increased risk, and mNEXSPIKE for adults aged 65 years and older and for patients aged 12 through 64 years at increased risk.
According to company materials, distribution will begin immediately, with availability in pharmacies, hospitals, and clinics in the coming days. Novavax’s Nuvaxovid 2025 to 2026 formula, a protein-based (non-mRNA) vaccine, was approved for adults 65 years and older and for patients aged 12 through 64 years at increased risk; according to company materials, Sanofi will lead US commercialization in fall 2025, and the formulation targets JN.1 with reported immunogenicity across circulating JN.1-lineage variants.
In a same-day post on X, Secretary Kennedy stated that emergency use authorizations for prior COVID-19 vaccines were rescinded and that the US Food and Drug Administration issued marketing authorizations for higher-risk populations: Moderna for patients aged 6 months and older, Pfizer for patients aged 5 years and older, and Novavax for patients aged 12 years and older. He noted that vaccines remain available for patients who choose vaccination after consultation with their physicians.
Company materials indicated that approval for Comirnaty LP.8.1 drew on the cumulative safety and efficacy data for the program, including clinical data supporting use in children aged 5 through 11 years of age, and preclinical data showing improved immune responses against multiple circulating sublineages versus prior JN.1- and KP.2-adapted vaccines. Moderna reported prior clearances for its LP.8.1-targeting vaccines in other jurisdictions and said US availability is expected within days.
Company materials for Pfizer, Moderna, and Novavax note rare severe allergic reactions, typically within minutes to 1 hour after vaccination; common, generally transient reactions such as injection-site pain/tenderness/redness, fatigue, headache, myalgia, chills, fever, and nausea/vomiting (lymphadenopathy also reported for the mRNA vaccines); and that vaccination may not protect all recipients, with reduced responses in patients who are immunocompromised. Myocarditis and pericarditis have been reported—most often in males aged 12 through 24 years for the mRNA vaccines—and Novavax also reports increased risks observed in clinical trials and postmarketing, with standard syncope precautions.
Sources: Pfizer Inc