Moderna COVID-19 Vaccine

Identification

Summary

Moderna COVID-19 Vaccine is an mRNA vaccine for the prevention of COVID-19, the disease caused by the SARS-CoV-2 virus, in patients aged 18 years and older.

Generic Name
Moderna COVID-19 Vaccine
DrugBank Accession Number
DB15654
Background

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
Approved, Investigational
Biologic Classification
Vaccines
Other vaccines
Synonyms
  • MRNA-1273 SARS-COV-2
External IDs
  • CX 024414
  • CX-024414
  • CX024414
  • mRNA-1273

Pharmacology

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

Pharmacology
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Drug Discovery
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
Medicalerrors
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Toxicity

There is limited information on clinical toxicity.

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.
DrugInteraction
AbataceptThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Amsacrine.
AnakinraThe 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).
Interactions
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Food Interactions
No interactions found.

Products

Products
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Covid-19 Vaccine ModernaInjectionIntramuscularModerna Biotech Spain, S.L.2021-03-17Not applicableEU flag
Covid-19 Vaccine ModernaInjectionIntramuscularModerna Therapeutics Inc2020-12-23Not applicableCanada flag
Moderna COVID-19 VaccineInjection, suspension0.2 mg/1mLIntramuscularModerna US, Inc.2020-12-18Not applicableUS flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Moderna COVID-19 VaccineModerna COVID-19 Vaccine (0.2 mg/1mL)Injection, suspensionIntramuscularModerna US, Inc.2020-12-18Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
EPK39PL4R4
CAS number
Not Available

References

General References
  1. 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]
  2. 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]
  3. Pharmaceutical Business Review: Moderna's mRNA-1273 vaccine [Link]
  4. Clinical Trials: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection [Link]
  5. FDA EUA Drug Products: Moderna COVID-19 Vaccine [Link]
  6. FDA Press Announcements: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [Link]
  7. Health Canada: Regulatory Decision Summary - Moderna COVID-19 Vaccine [Link]
Wikipedia
COVID-19_vaccine

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Vaccine Preventable Disease1
4RecruitingOtherCoronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19)1
3Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
3Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Rheumatic Diseases / Rheumatoid Arthritis / Systemic Lupus Erythematosus (SLE)1
3RecruitingOtherCoronavirus Disease 2019 (COVID‑19) / Immunocompromised Patients1
3RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
2Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
2Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Leukemias / Malignancies, Hematologic / Malignant Lymphomas / Multiple Myeloma (MM) / Solid Tumor Malignancies1
2Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Prevention of COVID191
2Not Yet RecruitingTreatmentChronic Stable Illness / Healthy Volunteers1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntramuscular
Injection, suspensionIntramuscular0.2 mg/1mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created on April 01, 2020 15:14 / Updated on March 03, 2021 21:58