Moderna COVID-19 Vaccine
Identification
- Name
- Moderna COVID-19 Vaccine
- Accession Number
- DB15654
- Description
The Moderna COVID-19 Vaccine (mRNA-1273) is a novel mRNA-based vaccine encapsulated in a lipid nanoparticle that encodes for a full-length pre-fusion stabilized spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by the novel coronavirus, SARS-CoV-2, leading to a respiratory illness alongside other complications. COVID-19 has high interpatient variability in symptoms, ranging from mild symptoms to severe illness.5 A phase I, open-label, dose-ranging clinical trial (NCT04283461) was initiated in March 2020 in which 45 subjects received two intramuscular doses (on days 1 and 29).4 This trial was later followed by phase II and III trials, where the Moderna COVID-19 Vaccine demonstrated vaccine efficacy of 94.1%.5
On December 18, 2020, the FDA issued an emergency use authorization (EUA) for the Moderna COVID-19 Vaccine as the second vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in patients aged 18 years and older, after the EUA issued for the Pfizer-BioNTech Covid-19 Vaccine on December 11, 2020. The Moderna COVID-19 Vaccine is administered as a series of two intramuscular injections, one month (28 days) apart. In clinical trials, there were no differences in the safety profiles between younger and older (65 years of age and older) study participants; however, the safety and effectiveness of the Moderna COVID-19 Vaccine have not been assessed in persons less than 18 years of age.5 On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine.7
- Type
- Biotech
- Groups
- Investigational
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- MRNA-1273 SARS-COV-2
- External IDs
- CX 024414
- CX-024414
- CX024414
- mRNA-1273
Pharmacology
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- Indication
The Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. It is administered in two doses, one month (28 days) apart.5
- Associated Conditions
- Contraindications & Blackbox Warnings
- Contraindications & Blackbox WarningsWith our commercial data, access important information on dangerous risks, contraindications, and adverse effects.Our Blackbox Warnings cover Risks, Contraindications, and Adverse Effects
- Pharmacodynamics
The Moderna COVID-19 Vaccine contains nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus. It has the potential to elicit a highly S-protein specific antiviral response.1 In clinical trials, the Moderna COVID-19 Vaccine demonstrated vaccine efficacy of 94.1%; however, the manufacturing company emphasizes that the vaccine may not protect all vaccine recipients against COVID-19, as some vaccinated patients still contracted the virus.5
- Mechanism of action
The Moderna COVID-19 Vaccine is a vaccine that contains 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-2.2 The S glycoprotein is a large transmembrane protein that plays a critical role in viral attachment, fusion, and entry into the host cell.1 Upon vaccination, human cells express the SARS-CoV-2 S antigen and immune response to the S antigen is elicited, leading to the protection against SARS-CoV-2.5
- Absorption
There is limited pharmacokinetic information.
- Volume of distribution
There is limited pharmacokinetic information.
- Protein binding
There is limited pharmacokinetic information.
- Metabolism
There is limited pharmacokinetic information.
- Route of elimination
There is limited pharmacokinetic information.
- Half-life
There is limited pharmacokinetic information.
- Clearance
There is limited pharmacokinetic information.
- Adverse Effects
- Reduce medical errorsand improve treatment outcomes with our comprehensive & structured data on drug adverse effects.Reduce medical errors & improve treatment outcomes with our adverse effects data
- Toxicity
There is limited information on clinical toxicity.
- Affected organisms
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Alemtuzumab. Altretamine The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Altretamine. Amsacrine The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Amsacrine. Anakinra The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Anakinra. Antilymphocyte immunoglobulin (horse) The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Antilymphocyte immunoglobulin (horse). Antithymocyte immunoglobulin (rabbit) The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit). Improve patient outcomesBuild effective decision support tools with the industry’s most comprehensive drug-drug interaction checker.Learn more - Food Interactions
- No interactions found.
Products
- Comprehensive & structured drug product infoFrom application numbers to product codes, connect different identifiers through our commercial datasets.Easily connect various identifiers back to our datasets
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Moderna COVID-19 Vaccine Injection, suspension 0.2 mg/1mL Intramuscular Moderna US, Inc. 2020-12-18 Not applicable US Moderna COVID-19 Vaccine Suspension 100 mcg Intramuscular Moderna Therapeutics Inc 2020-12-23 Not applicable Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Moderna COVID-19 Vaccine Moderna COVID-19 Vaccine (0.2 mg/1mL) Injection, suspension Intramuscular Moderna US, Inc. 2020-12-18 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
Chemical Identifiers
- UNII
- EPK39PL4R4
- CAS number
- Not Available
References
- General References
- 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. [PubMed:32800805]
- 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. [PubMed:32663912]
- Pharmaceutical Business Review: Moderna's mRNA-1273 vaccine [Link]
- Clinical Trials: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection [Link]
- FDA EUA Drug Products: Moderna COVID-19 Vaccine [Link]
- FDA Press Announcements: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [Link]
- Health Canada: Regulatory Decision Summary - Moderna COVID-19 Vaccine [Link]
- External Links
- Wikipedia
- COVID-19_vaccine
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Active Not Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) 1 2, 3 Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) 1 1 Active Not Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / COVID-19 Immunisation 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 0.2 mg/1mL Suspension Intramuscular 100 mcg - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created on April 01, 2020 15:14 / Updated on January 08, 2021 01:07