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BNT162b2 Omi LP.8.1

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

Overview

BNT162b2 Omi LP.8.1 is a monovalent mRNA vaccine developed by Pfizer and BioNTech, specifically engineered to target the LP.8.1 variant of SARS-CoV-2, which is a derivative of the JN.1 Omicron lineage. As part of the Comirnaty product line, it utilizes lipid nanoparticle (LNP) technology to deliver messenger RNA encoding the viral spike protein into host cells, thereby eliciting a targeted immune response. This formulation was selected for the 2025-2026 COVID-19 vaccination season following preclinical evidence of superior neutralizing antibody induction against contemporary JN.1 sublineages compared to previous variant-adapted vaccines. Clinical evaluation has demonstrated significant effectiveness against emergency department, urgent care, and outpatient visits during the early 2025-2026 respiratory virus season.

Brand names: Comirnaty
Other names: BNT162b2 (2025/2026 formulation)tozinameran (LP.8.1 variant)2025-2026 COVID-19 vaccine formula

Targets

Omicron S (SARS-CoV-2 Omicron spike protein)

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