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Comirnaty Omicron XBB.1.5
Comirnaty Omicron XBB.1.5 is an mRNA vaccine that instructs cells to produce the spike protein of the XBB.1.5 Omicron variant, triggering immune recognition and antibody production against this SARS-CoV-2 strain.
Comirnaty Omicron XBB.1.5 is an mRNA vaccine that instructs cells to produce the spike protein of the XBB.1.5 Omicron variant, triggering immune recognition and antibody production against this SARS-CoV-2 strain. Used for Prevention of COVID-19 caused by SARS-CoV-2 (Omicron XBB.1.5 subvariant).
At a glance
| Generic name | Comirnaty Omicron XBB.1.5 |
|---|---|
| Sponsor | Jules Bordet Institute |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (XBB.1.5 variant) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine delivers lipid nanoparticle-encapsulated mRNA encoding the spike protein of the XBB.1.5 Omicron subvariant. Upon intramuscular injection, the mRNA is translated by host cells to produce the antigen, which stimulates both humoral (antibody) and cellular (T-cell) immune responses. This updated formulation targets circulating Omicron subvariants to enhance protection against infection and severe disease.
Approved indications
- Prevention of COVID-19 caused by SARS-CoV-2 (Omicron XBB.1.5 subvariant)
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
- Chills
Key clinical trials
- Korea Comirnaty Post-marketing Surveillance
- Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial (PHASE3)
- Anti-viral Action Against Type 1 Diabetes Autoimmunity (PHASE4)
- Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years
- PREPARE-iVAC Trial (PHASE4)
- COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (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 Omicron XBB.1.5 CI brief — competitive landscape report
- Comirnaty Omicron XBB.1.5 updates RSS · CI watch RSS
- Jules Bordet Institute portfolio CI