Identification
- Summary
Imelasomeran is a component of a bivalent COVID-19 mRNA vaccine encoding the viral spike protein of Omicron variant lineage BA.1.
- Generic Name
- Imelasomeran
- DrugBank Accession Number
- DB17090
- Background
Imelasomeran was first approved in Canada on September 1, 2022, as one-half of Moderna's Spikevax Bivalent COVID-19 mRNA vaccine.3 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 2021.4
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- Imelasomeran
Pharmacology
- 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-19.3 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.3 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.3
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to prevent Coronavirus disease 2019 (covid‑19) Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654) •••••••••••• ••••••••• Used in combination to prevent Coronavirus disease 2019 (covid‑19) Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654) •••••••••••• ••••••••• - Contraindications & Blackbox Warnings
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Not Available
- Mechanism of action
Moderna's COVID-19 mRNA vaccine is composed of synthetic nucleoside-modified messenger RNA (mRNA) encapsulated in lipid nanoparticle (LNP) which codes for the full-length, pre-fusion stabilized spike protein (S) of SARS-CoV-2.1 The S glycoprotein is a large transmembrane protein that plays a critical role in viral attachment, fusion, and entry into the host cell.2 Upon vaccination, human cells express the SARS-CoV-2 S antigen and immune response to the S antigen is elicited, leading to protection against SARS-CoV-2.3
Imelasomeran is a component of one of Moderna's bivalent COVID-19 mRNA vaccines. It encodes the pre-fusion stabilized S glycoprotein of SARS-CoV-2 Omicron variant B.1.1.5293 in order to elicit specific protection against this variant.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Moderna COVID-19 Vaccine, Bivalent Injection, suspension 0.1 mg/1mL Intramuscular Moderna US, Inc. 2022-06-13 Not applicable US 
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Spikevax Bivalent Imelasomeran (0.05 mg / mL) + Moderna COVID-19 Vaccine (0.05 mg / mL) Intramuscular Moderna Biopharma Canada Corporation 2022-09-12 Not applicable Canada 
- Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Moderna COVID-19 Vaccine, Bivalent Imelasomeran (0.1 mg/1mL) Injection, suspension Intramuscular Moderna US, Inc. 2022-06-13 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans
Chemical Identifiers
- UNII
- 5295LF55B6
- CAS number
- 2763208-92-8
References
- General References
- Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH: An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Jul 14. doi: 10.1056/NEJMoa2022483. [Article]
- Kaur SP, Gupta V: COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020 Oct 15;288:198114. doi: 10.1016/j.virusres.2020.198114. Epub 2020 Aug 13. [Article]
- Health Canada Product Monograph: Spikevax Bivalent (Original / BA.1 Omicron) dispersion for intramuscular injection [Link]
- WHO: Tracking SARS-CoV-2 Variants [Link]
- External Links
- Wikipedia
- Moderna_COVID-19_vaccine
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Terminated Prevention Cancer / Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Treatment Chronic Lymphocytic Leukemia / Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines / Human Immunodeficiency Virus (HIV) Infections / Multiple Myeloma (MM) / Non-Hodgkin's Lymphoma (NHL) / Transplantation, Organ 1 2 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Immunogenicity / Pandemic, COVID-19 1 2 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Juvenile Dermatomyositis (JDM) / Juvenile Idiopathic Arthritis (JIA) / Multiple Sclerosis / Pediatric Onset Multiple Sclerosis (POMS) / Pediatric SLE / Pemphigus Vulgaris (PV) / Rheumatoid Arthritis / Systemic Lupus Erythematosus / Systemic Sclerosis (SSc) 1 Not Available Active Not Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 0.1 mg/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at November 04, 2022 17:41 / Updated at December 01, 2023 10:35