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BNT162b5 Bivalent (Original/OMI BA.4/BA.5) (bnt162b5-bivalent-original-omi-ba-4-ba-5)
Targets the SARS-CoV-2 virus to prevent and treat COVID-19
BNT162b5 Bivalent (Original/OMI BA.4/BA.5) holds a significant market position as one of Pfizer's leading COVID-19 vaccines, potentially becoming the world's best-selling drug. Its competitive advantage lies in its bivalent formulation, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/BA.5 subvariants, similar to COMIRNATY Original & Omicron BA.4/BA.5. A key risk is the lack of clinical trial data, which may affect regulatory approval and public confidence. The pipeline outlook remains robust, with ongoing development leveraging the established characteristics of BNT162b2 and other bivalent formulations.
At a glance
| Generic name | bnt162b5-bivalent-original-omi-ba-4-ba-5 |
|---|---|
| Sponsor | Pfizer |
| Drug class | mRNA vaccine |
| Target | Spike protein of SARS-CoV-2 |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
BNT162b5 Bivalent is a vaccine that works by introducing a piece of genetic material from the SARS-CoV-2 virus to the body. This triggers an immune response, allowing the body to recognize and fight the virus. The vaccine is designed to provide long-term protection against COVID-19.
Approved indications
- COVID-19 prevention
- COVID-19 treatment
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
- Atazanavir
- Cobicistat
- Darunavir
- Lopinavir
- Ritonavir
- Saquinavir
- Tipranavir
- Etravirine
- Fosamprenavir
- Indinavir
- Nelfinavir
- Rilpivirine
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:
- BNT162b5 Bivalent (Original/OMI BA.4/BA.5) CI brief — competitive landscape report
- BNT162b5 Bivalent (Original/OMI BA.4/BA.5) updates RSS · CI watch RSS
- Pfizer portfolio CI