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BNT162b6 Bivalent (Original/OMI BA.4/BA.5) (bnt162b6-bivalent-original-omi-ba-4-ba-5)
Pfizer's BNT162b6 Bivalent is a marketed COVID-19 vaccine for individuals 12 years and older, with certain immunocompromised individuals also eligible. It is a bivalent vaccine, targeting both the original and OMI BA.4/BA.5 strains. The vaccine has generated significant revenue, with $63.6B in sales. Its key indications include COVID-19 prevention in various age groups and immunocompromised individuals. The vaccine's mechanism is not explicitly stated, but it is a mRNA-based vaccine. Pfizer's BNT162b6 Bivalent has become a significant player in the COVID-19 vaccine market. The company continues to develop and refine its vaccine pipeline.
At a glance
| Generic name | bnt162b6-bivalent-original-omi-ba-4-ba-5 |
|---|---|
| Sponsor | Pfizer |
| Drug class | vaccine |
| Target | SARS-CoV-2 spike protein |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- COVID-19 prevention in individuals 12 years of age and older
- COVID-19 prevention in individuals 5 years of age and older
- COVID-19 prevention in individuals 6 months through 4 years of age
- COVID-19 prevention in individuals 5 years of age and older with certain immunocompromised individuals
- COVID-19 prevention in individuals 12 years of age and older with certain immunocompromised individuals
- COVID-19 prevention in individuals 6 months through 4 years of age with certain immunocompromised individuals
- COVID-19 prevention in individuals 5 years of age and older with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any COVID-19 vaccine
- COVID-19 prevention in individuals 12 years of age and older with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any COVID-19 vaccine
- COVID-19 prevention in individuals 6 months through 4 years of age with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any COVID-19 vaccine
Common side effects
- Injection site pain (PAIN)
- Fatigue (FATIGUE)
- Headache (HEADACHE)
- Myalgia (MUSCLE PAIN)
- Chills (CHILLS)
- Arthralgia (JOINT PAIN)
- Diarrhoea (DIARRHEA)
- Injection site swelling (SWELLING)
- Injection site erythema (REDNESS)
- COVID-19
- Pyrexia (FEVER)
- Vomiting (VOMITING)
Drug interactions
- Warfarin
- P-glycoprotein inhibitors
- P-glycoprotein inducers
- CYP3A4 inducers
- CYP3A4 inhibitors
Key clinical trials
- A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (PHASE2, PHASE3)
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:
- BNT162b6 Bivalent (Original/OMI BA.4/BA.5) CI brief — competitive landscape report
- BNT162b6 Bivalent (Original/OMI BA.4/BA.5) updates RSS · CI watch RSS
- Pfizer portfolio CI