Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
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.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on BNT162b2 Omi XBB.1.5 + RIV.