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The Pfizer mRNA-based BNT162b2 vaccine
BNT162b2 is an mRNA vaccine that instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response to prevent COVID-19 infection.
BNT162b2 is an mRNA vaccine that instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response to prevent COVID-19 infection. Used for Prevention of COVID-19 in individuals 6 months of age and older, Booster vaccination for COVID-19 prevention.
At a glance
| Generic name | The Pfizer mRNA-based BNT162b2 vaccine |
|---|---|
| Sponsor | dafna yahav |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (S protein) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine delivers lipid nanoparticle-encapsulated messenger RNA encoding the full-length, stabilized spike protein of SARS-CoV-2. Upon intramuscular injection, the mRNA is translated by host ribosomes to produce spike protein antigen, which activates both CD8+ T-cell and B-cell adaptive immune responses. This generates neutralizing antibodies and cellular immunity against the virus without introducing live virus or viral DNA.
Approved indications
- Prevention of COVID-19 in individuals 6 months of age and older
- Booster vaccination for COVID-19 prevention
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Chills
- Fever
- Lymphadenopathy
Key clinical trials
- Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction (PHASE4)
- Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia. (PHASE3)
- Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda (PHASE2)
- Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients (PHASE2)
- Vaccine Responses in Patients With B Cell Malignancies (PHASE4)
- COVID Protection After Transplant-Immunosuppression Reduction (PHASE2)
- COVID-19 Vaccination of Immunodeficient Persons (COVAXID) (PHASE4)
- A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults (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:
- The Pfizer mRNA-based BNT162b2 vaccine CI brief — competitive landscape report
- The Pfizer mRNA-based BNT162b2 vaccine updates RSS · CI watch RSS
- dafna yahav portfolio CI