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Comirnaty Original/Omicron BA.4-5
This bivalent mRNA vaccine encodes spike proteins from the original SARS-CoV-2 strain and the Omicron BA.4-5 variants to elicit adaptive immune responses against multiple circulating viral lineages.
This bivalent mRNA vaccine encodes spike proteins from the original SARS-CoV-2 strain and the Omicron BA.4-5 variants to elicit adaptive immune responses against multiple circulating viral lineages. Used for COVID-19 prevention in adults and adolescents (booster dose).
At a glance
| Generic name | Comirnaty Original/Omicron BA.4-5 |
|---|---|
| Sponsor | Jules Bordet Institute |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (original strain and Omicron BA.4-5 variants) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Comirnaty Original/Omicron BA.4-5 is a reformulated COVID-19 vaccine containing mRNA sequences encoding spike proteins from both the ancestral Wuhan strain and the Omicron BA.4-5 subvariants. The mRNA is delivered via lipid nanoparticles into host cells, where it is translated to produce spike antigen, triggering both humoral (antibody) and cellular (T-cell) immune responses. This bivalent approach aims to provide broader protection against multiple circulating SARS-CoV-2 variants.
Approved indications
- COVID-19 prevention in adults and adolescents (booster dose)
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
Key clinical trials
- 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)
- Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial (PHASE3)
- COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (PHASE4)
- Immunogenicity and Safety of Comvigen (Bivalent) Vaccine (PHASE2)
- The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose (PHASE2)
- Immunogenicity and Reactogenicity of the 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 (PHASE3)
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 Original/Omicron BA.4-5 CI brief — competitive landscape report
- Comirnaty Original/Omicron BA.4-5 updates RSS · CI watch RSS
- Jules Bordet Institute portfolio CI