What is BNT162b2 (Omi XBB.1.5)/RIV used for?

BNT162b2 (Omi XBB.1.5)/RIV is indicated for Prevention of COVID-19 in individuals 6 months of age and older, Prevention of COVID-19 in individuals 5 years of age and older, Prevention of COVID-19 in individuals 12 years of age and older, Prevention of COVID-19 in individuals 6 months of age and older, when administered as a third dose in a series of the Pfizer-BioNTech COVID-19 Vaccine, Prevention of COVID-19 in individuals 5 years of age and older, when administered as a third dose in a series of the Pfizer-BioNTech COVID-19 Vaccine.

Who makes BNT162b2 (Omi XBB.1.5)/RIV?

BNT162b2 (Omi XBB.1.5)/RIV is developed by Pfizer.

What development phase is BNT162b2 (Omi XBB.1.5)/RIV in?

BNT162b2 (Omi XBB.1.5)/RIV is FDA-approved (marketed).

What is the generic name of BNT162b2 (Omi XBB.1.5)/RIV?

bnt162b2-omi-xbb-1-5-riv is the generic (nonproprietary) name of BNT162b2 (Omi XBB.1.5)/RIV.

Last reviewed 2026-05-16 · How we verify

BNT162b2 (Omi XBB.1.5)/RIV (bnt162b2-omi-xbb-1-5-riv)

Pfizer · FDA-approved active Quality 50/100

Pfizer's BNT162b2 (Omi XBB.1.5)/RIV is a marketed vaccine for COVID-19 prevention in individuals 6 months and older. It is a mRNA-based vaccine developed by Pfizer Inc. The vaccine's mechanism involves the use of a piece of genetic material called messenger RNA (mRNA) to instruct cells in the body to produce a protein that triggers an immune response. This immune response helps protect against COVID-19. The vaccine has been shown to be effective in preventing severe illness and hospitalization due to COVID-19. With a revenue of 63.6 billion, it is a commercially significant vaccine. Pfizer continues to develop and improve its COVID-19 vaccine pipeline.

At a glance

Generic name	bnt162b2-omi-xbb-1-5-riv
Sponsor	Pfizer
Drug class	vaccine
Target	SARS-CoV-2
Therapeutic area	Immunology
Phase	FDA-approved

Approved indications

Prevention of COVID-19 in individuals 6 months of age and older
Prevention of COVID-19 in individuals 5 years of age and older
Prevention of COVID-19 in individuals 12 years of age and older
Prevention of COVID-19 in individuals 6 months of age and older, when administered as a third dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as a third dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 12 years of age and older, when administered as a third dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 6 months of age and older, when administered as a fourth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as a fourth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 12 years of age and older, when administered as a fourth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 6 months of age and older, when administered as a fifth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as a fifth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 12 years of age and older, when administered as a fifth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 6 months of age and older, when administered as a sixth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as a sixth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 12 years of age and older, when administered as a sixth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 6 months of age and older, when administered as a seventh dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as a seventh dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 12 years of age and older, when administered as a seventh dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 6 months of age and older, when administered as an eighth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine
Prevention of COVID-19 in individuals 5 years of age and older, when administered as an eighth dose in a series of the Pfizer-BioNTech COVID-19 Vaccine

Common side effects

No common side effects on file.

Drug interactions

Warfarin
Rivaroxaban
Apixaban
Dabigatran
Cyclosporine
Tacrolimus
Sirolimus
Everolimus
Mycophenolate
Azathioprine
Methotrexate
Leflunomide

Key clinical trials

A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BNT162b2 (Omi XBB.1.5)/RIV CI brief — competitive landscape report
BNT162b2 (Omi XBB.1.5)/RIV updates RSS · CI watch RSS
Pfizer portfolio CI