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Comirnaty Vaccine
Comirnaty Vaccine is a mRNA vaccine Biologic drug developed by Clover Biopharmaceuticals AUS Pty. It is currently in Phase 3 development for Prevention of COVID-19 disease caused by SARS-CoV-2.
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 disease caused by SARS-CoV-2.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comirnaty Vaccine |
|---|---|
| Sponsor | Clover Biopharmaceuticals AUS Pty |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (S protein) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine delivers lipid nanoparticle-encapsulated messenger RNA encoding the full-length 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 mediated immunity. This dual immune response generates neutralizing antibodies and cellular immunity to protect against severe COVID-19 disease.
Approved indications
- Prevention of COVID-19 disease caused by SARS-CoV-2
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
- Nausea
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)
- Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly
- Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine (PHASE2, PHASE3)
- A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults. (PHASE1, PHASE2)
- Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients (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)
- COVID Protection After Transplant-Immunosuppression Reduction (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:
- Comirnaty Vaccine CI brief — competitive landscape report
- Comirnaty Vaccine updates RSS · CI watch RSS
- Clover Biopharmaceuticals AUS Pty portfolio CI
Frequently asked questions about Comirnaty Vaccine
What is Comirnaty Vaccine?
How does Comirnaty Vaccine work?
What is Comirnaty Vaccine used for?
Who makes Comirnaty Vaccine?
What drug class is Comirnaty Vaccine in?
What development phase is Comirnaty Vaccine in?
What are the side effects of Comirnaty Vaccine?
What does Comirnaty Vaccine target?
Related
- Drug class: All mRNA vaccine drugs
- Target: All drugs targeting SARS-CoV-2 spike protein (S protein)
- Manufacturer: Clover Biopharmaceuticals AUS Pty — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of COVID-19 disease caused by SARS-CoV-2
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing