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BioNTech - Pfizer COVID-19 vaccine
This mRNA vaccine instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response that protects against COVID-19 infection.
This mRNA vaccine instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response that protects against COVID-19 infection. Used for COVID-19 prevention in individuals 6 months of age and older, COVID-19 booster vaccination.
At a glance
| Generic name | BioNTech - Pfizer COVID-19 vaccine |
|---|---|
| Also known as | Cominarty |
| Sponsor | University of Birmingham |
| 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 spike protein of SARS-CoV-2. Once inside cells, the mRNA is translated into spike protein, which is presented to the immune system, stimulating both CD8+ T-cell and B-cell responses including neutralizing antibody production. This adaptive immune response provides protection against subsequent SARS-CoV-2 exposure.
Approved indications
- COVID-19 prevention in individuals 6 months of age and older
- COVID-19 booster vaccination
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
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)
- Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
- Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration. (PHASE2)
- 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)
- A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People (PHASE1, PHASE2)
- Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. (NA)
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:
- BioNTech - Pfizer COVID-19 vaccine CI brief — competitive landscape report
- BioNTech - Pfizer COVID-19 vaccine updates RSS · CI watch RSS
- University of Birmingham portfolio CI