Drug intelligence / Profile preview

BNT162b2 Omi XBB.1.5 + RIV

Development stage
Unknown
Lead developer
BioNTech
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

The drug is a **combination vaccine formulation** containing: - BNT162b2 Omi XBB.1.5: an mRNA-based vaccine encoding a **prefusion-stabilized, full-length SARS-CoV-2 spike glycoprotein** specific for the Omicron XBB.1.5 variant. This mRNA is delivered in lipid nanoparticles and is designed to prompt the body's immune system to generate neutralizing antibodies and T cell responses against Omicron XBB.1.5 and its sublineages by expressing the modified spike protein with sequence changes corresponding to XBB.1.5, aiming for enhanced coverage against current circulating variants. - "RIV" is not documented in available scientific or regulatory literature as a COVID-19 vaccine component or as a part of the BNT162b2 vaccine series up to September 2025. If "RIV" refers to recombinant influenza vaccine (a common meaning), this would represent a co-formulation for simultaneous influenza and COVID-19 immunization, but there is no evidence of an officially approved or trialed dual formulation (BNT162b2 Omi XBB.1.5 + influenza recombinant vaccine) under the exact name "BNT162b2 Omi XBB.1.5 + RIV" in the published clinical trial or regulatory literature as of 2025[1][2][3]. Thus, as of this date, the available information robustly describes BNT162b2 Omi XBB.1.5, but the "+ RIV" formulation remains unclear and likely refers to an experimental or hypothetical combination. BNT162b2 Omi XBB.1.5 (monovalent) is indicated for the **prevention of COVID-19** caused by SARS-CoV-2, specifically XBB sublineages, by eliciting neutralizing antibodies and a Th1-skewed cellular immune response.

Brand names
Comirnaty Omicron XBB.1.5
Other names
monovalent Omicron XBB.1.5-adapted BNT162b2
02

Targets

ACE2 (Angiotensin-converting enzyme 2)

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