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.

Brand Names
Spikevax
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 first 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.5 On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine.7

In November 2021, Health Canada and the EMA authorized the use of the Moderna COVID-19 vaccine as a booster shot to be given at least six months following the primary vaccination series and at half (50 mcg) of its regular strength.8,11 A similar booster dose is also available in the US for patients 18 years of age and older.10 The Moderna COVID-19 Vaccine was fully approved by the FDA on January 31, 2022 15 and Health Canada expanded the use of the Moderna COVID-19 Vaccine to include individuals aged six to 11.12 The Moderna COVID-19 vaccine is also approved for use as a fourth booster shot in adults 50 years of age and older.16

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

Pharmacology

Indication

The Moderna COVID-19 Vaccine is indicated 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 in the US and Europe,14 and in individuals 6 months of age and older in Canada.12 In the US, under the emergency use authorization, the Moderna COVID-19 Vaccine is used for the prevention of COVID-19 in children 6 months of age and older.[L42770]

It is administered in two doses, one month (28 days) apart.5 A booster dose of the vaccine, to be given at least 6 months following the initial vaccine series, is approved for use in all patients 18 years of age and older in Canada and the US.8,10,11 The Moderna COVID-19 vaccine is also approved for use as a fourth booster shot in adults 50 years of age and older.16

A new bivalent formulation of the Moderna vaccine which includes davesomeran was approved in November 2022 by Health Canada and in August 2022 by the FDA against the BA.4 and BA.5 omicron variants.[L43862,

Reduce drug development failure rates
Build, train, & validate machine-learning models
with evidence-based and structured datasets.
See how
Build, train, & validate predictive machine-learning models with structured datasets.
See how
Associated Conditions
Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug events
Improve clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.
Learn more
Avoid life-threatening adverse drug events & improve clinical decision support.
Learn more
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
Improve decision support & research outcomes
With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.
Learn more
Improve decision support & research outcomes with our structured adverse effects data.
Learn more
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.
AnifrolumabThe therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Anifrolumab.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Moderna COVID-19 Vaccine can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Identify potential medication risks
Easily compare up to 40 drugs with our drug interaction checker.
Get severity rating, description, and management advice.
Learn more
Food Interactions
No interactions found.

Products

Drug product information from 10+ global regions
Our datasets provide approved product information including:
dosage, form, labeller, route of administration, and marketing period.
Access now
Access drug product information from over 10 global regions.
Access now
International/Other Brands
Spikevax (ModernaTX, Inc.)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Covid-19 Vaccine ModernaInjection100 µgIntramuscularModerna Biotech Spain, S.L.2021-03-17Not applicableEU flag
Covid-19 Vaccine ModernaInjection100 µgIntramuscularModerna Biotech Spain, S.L.2022-06-092022-03-07EU flag
Moderna COVID-19 VaccineInjection, suspension0.1 mg/1mLIntramuscularModerna US, Inc.2022-03-29Not applicableUS flag
Moderna COVID-19 VaccineInjection, suspension0.1 mg/1mLIntramuscularModerna US, Inc.2022-04-12Not applicableUS flag
Moderna COVID-19 VaccineInjection, suspension0.2 mg/1mLIntramuscularModerna US, Inc.2020-12-18Not applicableUS flag
Moderna COVID-19 VaccineInjection, suspension0.1 mg/1mLIntramuscularModerna US, Inc.2022-04-12Not applicableUS flag
SpikevaxInjection0.2 mg / mLIntramuscularModernatx, Inc.2020-12-23Not applicableCanada flag
SpikevaxInjection, suspension0.1 mg/0.5mLIntramuscularCatalent Indiana, LLC2022-04-01Not applicableUS flag
SpikevaxInjection, suspension0.2 mg/1mLIntramuscularModerna US, Inc.2022-04-01Not applicableUS flag
SpikevaxInjection0.1 mg / mLIntramuscularModernatx, Inc.2022-07-14Not applicableCanada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Spikevax BivalentModerna COVID-19 Vaccine (0.05 mg / mL) + Imelasomeran (0.05 mg / mL)IntramuscularModernatx, Inc.Not applicableNot applicableCanada flag
Spikevax Bivalent (original / Omicron Ba.4/5)Moderna COVID-19 Vaccine (0.05 mg / mL) + Davesomeran (0.05 mg / mL)InjectionIntramuscularModernatx, Inc.Not applicableNot applicableCanada flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Moderna COVID-19 VaccineModerna COVID-19 Vaccine (0.1 mg/1mL)Injection, suspensionIntramuscularModerna US, Inc.2022-03-29Not 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]
  8. Health Canada Statement: Health Canada authorizes the use of the Moderna Spikevax COVID-19 vaccine as a booster shot [Link]
  9. FDA COVID-19 Vaccines: Moderna COVID-19 Vaccine [Link]
  10. FDA News Release: FDA Expands Eligibility for COVID-19 Vaccine Boosters [Link]
  11. Summary of Product Characteristics: Spikevax (COVID-19 mRNA Vaccine, nucleoside modified) Intramuscular Injection [Link]
  12. Health Canada Product Monograph: Spikevax (elasomeran mRNA vaccine) for intramuscular injection [Link]
  13. EMA COVID-19 Vaccine Safety Update: Spikevax (Dec 9/21) [Link]
  14. FDA Approved Drug Products: SPIKEVAX (COVID-19 Vaccine, mRNA) Suspension for injection, for intramuscular use [Link]
  15. FDA News Release: Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine [Link]
  16. BioSpace News: Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus [Link]
  17. Health Canada Product Monograph: SPIKEVAX™ Bivalent (Elasomeran / davesomeran mRNA vaccine) for intramuscular injection [Link]
  18. Moderna COVID-19 Vaccines [Link]
RxNav
2470232
Wikipedia
COVID-19_vaccine

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines1
4Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
4CompletedPreventionCoronavirus Disease 2019 (COVID‑19) / Immunosuppression / Vaccine Response Impaired1
4CompletedPreventionCoronavirus Disease 2019 (COVID‑19) / Kidney Diseases / Vaccine Response Impaired1
4RecruitingOtherCoronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19)1
4RecruitingPreventionCancer / Coronavirus Disease 2019 (COVID‑19)1
4RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus1
4WithdrawnPreventionCoronavirus Disease 2019 (COVID‑19) / Vaccine Preventable Diseases1
3Active Not RecruitingOtherCoronavirus Disease 2019 (COVID‑19) / Immunocompromised Patients1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntramuscular100 µg
Injection, suspensionIntramuscular0.1 mg/1mL
Injection, suspensionIntramuscular0.2 mg/1mL
Injection, suspensionIntramuscular
InjectionIntramuscular0.1 mg / mL
InjectionIntramuscular0.2 mg / mL
Injection, suspensionIntramuscular0.1 mg/0.5mL
InjectionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at April 01, 2020 15:14 / Updated at December 06, 2022 13:41