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Identification
- Summary
Andusomeran is an mRNA vaccine for the prevention of COVID-19 caused by the SARS-CoV-2 virus, including the XBB.1.5 subvariant.
- Generic Name
- Andusomeran
- DrugBank Accession Number
- DB18227
- Background
Andusomeran is a COVID-19 mRNA vaccine developed for use during the 2023-2024 season.3,4,5 It is similar to previous mRNA vaccines developed by Moderna (e.g. elasomeran, imelasomeran), but is designed to be effective against the Omicron XBB.1.5 subvariant.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- COVID-19 mRNA vaccine, monovalent (XBB.1.5 Variant)
- CX-038839 Omicron (XBB.1.5)
Pharmacology
- Indication
Andusomeran is indicated for the prevention of COVID-19 caused by SARS-CoV-2.3,4 It is intended to elicit protection against the Omicron XBB.1.5 subvariant.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••••••• Prevention of Coronavirus disease 2019 (covid‑19) •••••••••••• ••••••••• Prevention of Novel coronavirus infectious disease (covid-19) •••••••••••• ••••••••• - Contraindications & Blackbox Warnings
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The safety and efficacy of andusomeran are primarily inferred from studies of the original Spikevax vaccine (elasomeran) and a previously approved bivalent vaccine (elasomeran and imelasomeran).4
- 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-2.4
Andusomeran is a COVID-19 mRNA vaccine that encodes for the pre-fusion stabilized S glycoprotein of the SARS-CoV-2 Omicron subvariant XBB.1.5 (containing mutations K982P and V983P) which is intended to elicit protection against this variant.4
- 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 Injection, suspension 25 ug/0.25mL Intramuscular Moderna US, Inc. 2023-09-11 2024-08-20 US 
Spikevax Injection, solution 50 ug/0.5mL Intramuscular Catalent Indiana, LLC 2023-09-11 Not applicable US Spikevax Injection, suspension 50 ug/0.5mL Intramuscular Moderna US, Inc. 2023-09-11 2024-08-15 US Spikevax XbB.1.5 Injection 0.1 mg / mL Intramuscular Moderna Biopharma Canada Corporation 2023-09-18 Not applicable Canada 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans
Chemical Identifiers
- UNII
- 4F9QRS7ZV2
- CAS number
- 2918977-08-7
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]
- FDA Approved Drug Products: Spikevax (COVID-19 Vaccine, mRNA) suspension for injection for intramuscular use (August 2024) [Link]
- Health Canada Product Monograph: Spikevax XBB.1.5 (monovalent COVID-19 vaccine, andusomeran) dispersion for intramuscular injection [Link]
- EMA EPAR: Spikevax (Moderna COVID-19 vaccine) [Link]
- External Links
- 2664725
- Wikipedia
- Moderna_COVID-19_vaccine
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Active Not Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide Not Available Recruiting Not Available Coronavirus Disease 2019 (COVID‑19) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 25 ug/0.25mL Injection, solution Intramuscular 50 ug/0.5mL Injection, suspension Intramuscular 50 ug/0.5mL Suspension Intramuscular 50 mcg Injection Intramuscular 0.1 mg / mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at September 14, 2023 15:54 / Updated at December 06, 2023 04:53