Moderna COVID-19 Vaccine
Identification
- Summary
Moderna COVID-19 Vaccine is an mRNA vaccine for the prevention of COVID-19 caused by the SARS-CoV-2 virus.
- 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 12 years of age and older in the US14 and in individuals 6 months of age and older in Canada and the EU.21,12 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.20
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 bivalent formulation of the Moderna vaccine which includes davesomeran - targeting the BA.4 and BA.5 Omicron variants - was approved in August 2022 by the FDA and in November 2022 by Health Canada. In Canada, an additional bivalent formulation which includes imelasomeran - targeting the BA.1 Omicron variant - was approved in September 2022, and may be used as a booster dose in individuals ≥6 years of age.19
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
- Contraindications & Blackbox Warnings
- Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API
- 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 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
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.
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. Anifrolumab The 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 risksEasily 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 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.
- International/Other Brands
- Spikevax (ModernaTX, Inc.)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Covid-19 Vaccine Moderna Injection 100 µg Intramuscular Moderna Biotech Spain, S.L. 2022-06-09 2022-03-07 EU Covid-19 Vaccine Moderna Injection 100 µg Intramuscular Moderna Biotech Spain, S.L. 2021-03-17 Not applicable EU Moderna COVID-19 Vaccine Injection, suspension 0.1 mg/1mL Intramuscular Moderna US, Inc. 2022-03-29 Not applicable US Moderna COVID-19 Vaccine Injection, suspension 0.1 mg/1mL Intramuscular Moderna US, Inc. 2022-04-12 Not applicable US Moderna COVID-19 Vaccine Injection, suspension 0.2 mg/1mL Intramuscular Moderna US, Inc. 2020-12-18 Not applicable US Moderna COVID-19 Vaccine Injection, suspension 0.1 mg/1mL Intramuscular Moderna US, Inc. 2022-04-12 Not applicable US Spikevax Injection 0.2 mg / mL Intramuscular Moderna Biopharma Canada Corporation 2020-12-23 Not applicable Canada Spikevax Injection, suspension 0.1 mg/0.5mL Intramuscular Catalent Indiana, LLC 2022-04-01 Not applicable US Spikevax Injection, suspension 0.2 mg/1mL Intramuscular Moderna US, Inc. 2022-04-01 Not applicable US Spikevax Injection 0.1 mg / mL Intramuscular Moderna Biopharma Canada Corporation 2022-07-14 Not applicable Canada - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Spikevax Bivalent Moderna COVID-19 Vaccine (0.05 mg / mL) + Imelasomeran (0.05 mg / mL) Intramuscular Moderna Biopharma Canada Corporation 2022-09-12 Not applicable Canada Spikevax Bivalent (original / Omicron Ba.4/5) Moderna COVID-19 Vaccine (0.05 mg / mL) + Davesomeran (0.05 mg / mL) Injection Intramuscular Moderna Biopharma Canada Corporation 2022-11-25 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 (0.1 mg/1mL) Injection, suspension Intramuscular Moderna US, Inc. 2022-03-29 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
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. [Article]
- 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]
- 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]
- Health Canada Statement: Health Canada authorizes the use of the Moderna Spikevax COVID-19 vaccine as a booster shot [Link]
- FDA COVID-19 Vaccines: Moderna COVID-19 Vaccine [Link]
- FDA News Release: FDA Expands Eligibility for COVID-19 Vaccine Boosters [Link]
- Summary of Product Characteristics: Spikevax (COVID-19 mRNA Vaccine, nucleoside modified) Intramuscular Injection [Link]
- Health Canada Product Monograph: Spikevax (elasomeran mRNA vaccine) for intramuscular injection [Link]
- EMA COVID-19 Vaccine Safety Update: Spikevax (Dec 9/21) [Link]
- FDA Approved Drug Products: Spikevax (COVID-19 Vaccine, mRNA) suspension for injection for intramuscular use (Updated Sept 2023) [Link]
- FDA News Release: Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine [Link]
- BioSpace News: Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus [Link]
- Health Canada Product Monograph: SPIKEVAX™ Bivalent (Elasomeran / davesomeran mRNA vaccine) for intramuscular injection [Link]
- Moderna COVID-19 Vaccines [Link]
- Health Canada Product Monograph: Spikevax Bivalent (Original / BA.1 Omicron) dispersion for intramuscular injection [Link]
- FDA NEWS RELEASE: Coronavirus (COVID-19) Update; FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age [Link]
- EMA EPAR: Spikevax (Moderna COVID-19 vaccine) [Link]
- External Links
- 2470232
- Wikipedia
- COVID-19_vaccine
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines 1 4 Completed Prevention Coronavirus Disease 2019 (COVID‑19) 1 4 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Immunosuppression / Vaccine Response Impaired 1 4 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Kidney Diseases / Vaccine Response Impaired 1 4 Completed Treatment Coronavirus Disease 2019 (COVID‑19) 1 4 Recruiting Other Coronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19) 1 4 Recruiting Prevention Cancer / Coronavirus Disease 2019 (COVID‑19) 1 4 Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Fever / Fever After Vaccination / Seizures Fever 1 4 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus 1 4 Withdrawn Prevention Coronavirus Disease 2019 (COVID‑19) / Vaccine Preventable Diseases 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intramuscular 100 µg Injection, suspension Intramuscular 0.1 mg/1mL Injection, suspension Intramuscular 0.2 mg/1mL Injection, suspension Intramuscular Injection Intramuscular 0.1 mg / mL Injection Intramuscular 0.2 mg / mL Injection, suspension Intramuscular 0.1 mg/0.5mL Injection Intramuscular - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at April 01, 2020 15:14 / Updated at December 01, 2023 10:35