Last reviewed · How we verify
BNT162b7 Monovalent (OMI BA.4/BA.5) (bnt162b7-monovalent-omi-ba-4-ba-5)
BNT162b7 Monovalent (OMI BA.4/BA.5) is an mRNA-based vaccine marketed by Pfizer for the prevention of COVID-19 in individuals 12 years of age and older. Its key strength lies in its targeted approach against the BA.4 and BA.5 variants, providing specific protection against these prevalent strains. The primary risk is competition from other Pfizer/BioNTech vaccines, including Comirnaty Bivalent formulations that target different Omicron variants (BA.1, BA.2) and a different formulation of the same BA.4/BA.5 vaccine.
At a glance
| Generic name | bnt162b7-monovalent-omi-ba-4-ba-5 |
|---|---|
| Sponsor | Pfizer |
| Drug class | vaccine |
| Target | SARS-CoV-2 spike protein |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Prevention of COVID-19 in individuals 12 years of age and older
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:
- BNT162b7 Monovalent (OMI BA.4/BA.5) CI brief — competitive landscape report
- BNT162b7 Monovalent (OMI BA.4/BA.5) updates RSS · CI watch RSS
- Pfizer portfolio CI