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COMIRNATY - BioNTech Manufacturing GmbH
COMIRNATY is an mRNA vaccine that instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response to prevent COVID-19 infection.
COMIRNATY 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 in individuals 12 years of age and older.
At a glance
| Generic name | COMIRNATY - BioNTech Manufacturing GmbH |
|---|---|
| Sponsor | Jens D Lundgren, MD |
| 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 contains lipid nanoparticles encapsulating messenger RNA encoding the spike protein of SARS-CoV-2. Upon intramuscular injection, the mRNA is taken up by host cells, which translate it to produce spike protein. This protein is presented to the immune system, stimulating both CD8+ T-cell and antibody responses that protect against subsequent SARS-CoV-2 infection.
Approved indications
- Prevention of COVID-19 in individuals 6 months of age and older
- Booster vaccination for COVID-19 in individuals 12 years of age and older
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Chills
- Fever
- Lymphadenopathy
Key clinical trials
- A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults (PHASE2)
- National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE) (PHASE4)
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:
- COMIRNATY - BioNTech Manufacturing GmbH CI brief — competitive landscape report
- COMIRNATY - BioNTech Manufacturing GmbH updates RSS · CI watch RSS
- Jens D Lundgren, MD portfolio CI