Overview
Imelasomeran was first approved in Canada on September 1, 2022, as one-half of Moderna's Spikevax Bivalent COVID-19 mRNA vaccine. It encodes for the viral spike protein of the Omicron BA.1 variant of SARS-CoV-2, a particularly infectious variant of concern first documented in 2021.
Indication
The Bivalent Moderna COVID-19 Vaccine (Original and Omicron BA.1) is a combination of imelasomeran and elasomeran (i.e. the monovalent Moderna COVID-19 Vaccine). It is indicated in Canada as a booster dose for the prevention of COVID-19. In patients 6-11 years of age, a dose of 25mcg may be given intramuscularly 6 months following completion of a primary vaccine series and/or previous booster dose. In patients ≥12 years of age, a dose of 50mcg may be given intramuscularly 4 months following completion of a primary vaccine series and/or previous booster dose.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
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No clinical trials found for this drug
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SPIKEVAX BIVALENT | moderna biopharma canada corporation | 02530252 | Dispersion - Intramuscular | 0.05 MG / ML | 9/12/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.1 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE | Moderna Biotech Spain S.L. | 1201507004 | DISPERSIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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