Drug intelligence / Profile preview

LP.8.1-adapted mRNA COVID-19 vaccine

Development stage
Approved
Lead developer
BioNTech
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
Administration
Intramuscular
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Overview

The LP.8.1-adapted mRNA COVID-19 vaccine is a monovalent vaccine developed by Pfizer and BioNTech, marketed under the brand name COMIRNATY as the 2025-2026 Formula. It utilizes modified RNA (modRNA) technology to encode the spike (S) glycoprotein of the SARS-CoV-2 Omicron sublineage LP.8.1, a descendant of the JN.1 variant. The vaccine is FDA-approved for active immunization to prevent COVID-19 in adults aged 65 and older and individuals aged 5 to 64 who are at high risk for severe outcomes. Administered via intramuscular injection, the vaccine leverages BioNTech's proprietary mRNA platform and Pfizer's manufacturing and regulatory infrastructure.

Brand names
COMIRNATY
Other names
LP.8.1-adapted mRNA COVID-19 vaccineCOMIRNATY (LP.8.1; COVID-19 Vaccine, mRNA)2025-2026 Formula COMIRNATYmonovalent LP.8.1 mRNA vaccine
02

Targets

SARS-CoV-2 spike

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