Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine has received full U.S. FDA approval for adults aged 65 and older as well as individuals aged 5 through 64 who are at increased risk of severe COVID-19 due to underlying health conditions. This updated vaccine formulation (LP.8.1-adapted) is designed to target current circulating strains of the virus, providing enhanced immune protection. The FDA’s approval is based on a strong body of clinical and real-world evidence demonstrating the vaccine’s safety and efficacy across these age groups.

The 2025-2026 COVID-19 vaccine season will see rapid shipping and availability of this updated vaccine in pharmacies, hospitals, and clinics nationwide to ensure timely protection for vulnerable populations. COMIRNATY remains a key tool in reducing severe illness, hospitalization, and death related to COVID-19, especially among seniors and high-risk individuals. With over 5 billion Pfizer-BioNTech vaccine doses distributed worldwide, its extensive safety profile continues to support its use in both adults and children 5 years and older.

Individuals who are 65+ or between 5 and 64 with conditions such as diabetes, heart disease, or immunocompromise should consider this vaccine update for enhanced protection against evolving COVID-19 variants. The vaccine is based on cutting-edge mRNA technology developed jointly by Pfizer and BioNTech, marking an important advancement in the ongoing fight against the pandemic.