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bivalent BNT162b2 (original/Omi BA.4/BA.5) (bivalent-bnt162b2-original-omi-ba-4-ba-5)
Pfizer's bivalent BNT162b2 (original/Omi BA.4/BA.5) is a marketed COVID-19 vaccine. It is developed by Pfizer Inc. The vaccine works by targeting the SARS-CoV-2 virus. It is indicated for COVID-19 prevention in individuals 5 years of age and older, and in individuals 6 months through 4 years of age. The vaccine has undergone 4 clinical trials and has generated $63.6B in revenue. It is a key player in the COVID-19 vaccine market. Pfizer continues to develop its pipeline of COVID-19 vaccines.
At a glance
| Generic name | bivalent-bnt162b2-original-omi-ba-4-ba-5 |
|---|---|
| Sponsor | Pfizer |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 virus |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- 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 12 years of age and older
- COVID-19 prevention in individuals 6 months through 4 years of age with a third dose administered at least 2 months after the second dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose
- COVID-19 prevention in individuals 6 months through 4 years of age with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose
- COVID-19 prevention in individuals 6 months through 4 years of age with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose
- COVID-19 prevention in individuals 6 months through 4 years of age with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose and a seventh dose administered at least 2 months after the sixth dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose and a seventh dose administered at least 2 months after the sixth dose
- COVID-19 prevention in individuals 6 months through 4 years of age with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose and a seventh dose administered at least 2 months after the sixth dose
- COVID-19 prevention in individuals 12 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose and a seventh dose administered at least 2 months after the sixth dose and an eighth dose administered at least 2 months after the seventh dose
- COVID-19 prevention in individuals 5 years of age and older with a third dose administered at least 2 months after the second dose and a fourth dose administered at least 2 months after the third dose and a fifth dose administered at least 2 months after the fourth dose and a sixth dose administered at least 2 months after the fifth dose and a seventh dose administered at least 2 months after the sixth dose and an eighth dose administered at least 2 months after the seventh dose
Common side effects
- Fatigue (FATIGUE)
- Injection site pain (PAIN)
- Headache (HEADACHE)
- Injection site pain (PAIN AT THE INJECTION SITE)
- Chills (CHILLS)
- Myalgia (MUSCLE PAIN)
- Diarrhoea (DIARRHEA)
- Arthralgia (JOINT PAIN)
- Injection site swelling (SWELLING)
- Injection site erythema (REDNESS)
- Myalgia (NEW OR WORSENED MUSCLE PAIN)
- Arthralgia (NEW OR WORSENED JOINT PAIN)
Drug interactions
- Warfarin
- Aspirin
- Pain medications (e.g., ibuprofen, naproxen)
- Blood thinners (e.g., heparin, enoxaparin)
- Anticoagulants (e.g., apixaban, rivaroxaban)
- Antiplatelet agents (e.g., clopidogrel, prasugrel)
- Live vaccines
- Interferon-alpha
- Immunosuppressants (e.g., corticosteroids, cyclosporine)
Key clinical trials
- Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People (PHASE1)
- A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (PHASE2, PHASE3)
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza (PHASE2)
- A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV). (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:
- bivalent BNT162b2 (original/Omi BA.4/BA.5) CI brief — competitive landscape report
- bivalent BNT162b2 (original/Omi BA.4/BA.5) updates RSS · CI watch RSS
- Pfizer portfolio CI