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BNT162b2 BA.4/5 bivalent (bnt162b2-ba-4-5-bivalent)
BNT162b2 BA.4/5 bivalent is a marketed COVID-19 vaccine developed by Pfizer Inc. It works by stimulating the body's immune system to produce antibodies against the SARS-CoV-2 virus. The vaccine is indicated for individuals 12 years of age and older, 5 years of age and older, and 6 months through 4 years of age. It has been clinically differentiated through its ability to provide protection against COVID-19 in various age groups. The vaccine's commercial significance is evident in its high revenue of $21.2B. Pfizer Inc. has not disclosed any pipeline developments for this vaccine.
At a glance
| Generic name | bnt162b2-ba-4-5-bivalent |
|---|---|
| Sponsor | Pfizer |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 virus |
| Modality | Vaccine |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Prevention of COVID-19 in individuals 12 years of age and older
- Prevention of COVID-19 in individuals 5 years of age and older
- Prevention of COVID-19 in individuals 6 months through 4 years of age
Common side effects
Drug interactions
- Warfarin
- Aspirin
- Pain medications (e.g., ibuprofen, naproxen)
- Anticoagulants (e.g., heparin, enoxaparin)
- Antiplatelet agents (e.g., clopidogrel, ticagrelor)
- Live vaccines
- Interferon-alpha
- Immunosuppressants (e.g., corticosteroids, cyclosporine)
- Chloroquine
- HIV protease inhibitors
Key clinical trials
- Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People (PHASE1)
- Korea Comirnaty Post-marketing Surveillance
- COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (PHASE2)
- A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (PHASE2, PHASE3)
- A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children (PHASE2, PHASE3)
- Pfizer-BioNTech COVID-19 Vaccine Effectiveness Study - Kaiser Permanente Southern California
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (PHASE2)
- Secondary Databased Post-marketing Surveillance Study of BNT162b2
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 BA.4/5 bivalent CI brief — competitive landscape report
- BNT162b2 BA.4/5 bivalent updates RSS · CI watch RSS
- Pfizer portfolio CI