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Comirnaty (BNT162b2 (tozinameran))
Comirnaty is an mRNA-based vaccine.
Comirnaty, developed by Pfizer, stands as a leading mRNA-based vaccine with a robust revenue of $3200M and 19 approved indications, positioning it strongly in the global market. Its competitive advantage lies in its established efficacy and safety profile, distinguishing it from antiviral treatments like Paxlovid and Remdesivir. A key risk is the lack of ongoing clinical trials, which may limit future expansion and adaptation to new variants. Despite this, the requirement for a PD-L1 companion diagnostic for several indications suggests a focused and potentially lucrative pipeline in specific therapeutic areas.
At a glance
| Generic name | BNT162b2 (tozinameran) |
|---|---|
| Also known as | tozinameran, COVID-19 mRNA vaccine (Pfizer-BioNTech), BNT162b2, PF-07302048 |
| Sponsor | Pfizer Inc. |
| Drug class | vaccine |
| Target | SARS-CoV-2 virus |
| Modality | mRNA vaccine |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2021-08-23 (US) |
| Annual revenue | 5400 |
Mechanism of action
Comirnaty is an mRNA-based vaccine developed by BioNTech in collaboration with Pfizer. It works by providing instructions to cells to produce a piece of the SARS-CoV-2 virus, which triggers an immune response. This immune response helps protect against COVID-19.
Approved indications
- Prevention of COVID-19 in individuals 6 months of age and older
- Prevention of COVID-19 in individuals 5 years of age and older
- Prevention of COVID-19 in individuals 12 years of age and older
- Prevention of COVID-19 in individuals 12 years of age and older, as a third dose administered at least 2 months after either the second dose of a 2-dose series or the first dose of a single-dose regimen
- Prevention of COVID-19 in individuals 12 years of age and older, as a fourth dose administered at least 2 months after the third dose
- Prevention of COVID-19 in individuals 12 years of age and older, as a second booster dose administered at least 4 months after the first booster dose
- Prevention of COVID-19 in individuals 12 years of age and older, as a second booster dose administered at least 4 months after the first booster dose, in individuals who received a second booster dose of a different COVID-19 vaccine
- Prevention of COVID-19 in individuals 12 years of age and older, as a second booster dose administered at least 4 months after the first booster dose, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine
- Prevention of COVID-19 in individuals 12 years of age and older, as a second booster dose administered at least 4 months after the first booster dose, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine
- Prevention of COVID-19 in individuals 12 years of age and older, as a second booster dose administered at least 4 months after the first booster dose, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine, in individuals who received a second booster dose of a different COVID-19 vaccine
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Common side effects
- Upper respiratory infection
- Platelet count decreased
- Creatinine increased
- Hypertension
- Increased AST/ALT
- Fatigue
- Increased LFTs
- Headache
- Anemia
- Vaccination site lymphadenopathy
- Tachypnea
- Monocyte count increased
Drug interactions
- Warfarin
- Live vaccines
- Interferon-alpha
- Immunosuppressants
- Corticosteroids
- Thalidomide
- Lenalidomide
- Pazopanib
- Sipuleucel-T
- BCG vaccine
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comirnaty CI brief — competitive landscape report
- Comirnaty updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI