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Comirnaty Original/Omicron BA.1
This bivalent mRNA vaccine encodes spike proteins from both the original SARS-CoV-2 strain and the Omicron BA.1 variant to elicit immune responses against multiple viral lineages.
This bivalent mRNA vaccine encodes spike proteins from both the original SARS-CoV-2 strain and the Omicron BA.1 variant to elicit immune responses against multiple viral lineages. Used for COVID-19 prevention in individuals 12 years of age and older (booster dose).
At a glance
| Generic name | Comirnaty Original/Omicron BA.1 |
|---|---|
| Sponsor | Jules Bordet Institute |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (original strain and Omicron BA.1 variant) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Comirnaty Original/Omicron BA.1 is a modified version of the original Comirnaty vaccine that includes mRNA sequences encoding spike proteins from both the ancestral SARS-CoV-2 strain and the Omicron BA.1 variant. When administered, the mRNA is translated into spike proteins that stimulate both humoral and cellular immune responses, providing broader protection against circulating variants. This bivalent approach aims to improve vaccine effectiveness against evolving viral strains.
Approved indications
- COVID-19 prevention in individuals 12 years of age and older (booster dose)
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
Key clinical trials
- 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)
- 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.1 CI brief — competitive landscape report
- Comirnaty Original/Omicron BA.1 updates RSS · CI watch RSS
- Jules Bordet Institute portfolio CI