Moderna COVID-19 vaccine

"Moderna vaccine" redirects here. For other Moderna vaccination topics, see Moderna.

Moderna COVID-19 vaccine
Vials of the Moderna COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Trade namesSpikevax[1][2]
Other namesmRNA-1273, CX-024414, COVID-19 mRNA Vaccine Moderna, TAK-919, Moderna COVID‑19 Vaccine, COVID‑19 Vaccine Moderna, COVID-19 Vaccine Moderna Intramuscular Injection,[3] elasomeran,[4][5] COVID-19 Vaccine (mRNA),[6] davesomeran,[4] imelasomeran,[4] andusomeran,[4] CX-034476, CX-038839
AHFS/Drugs.comMonograph
MedlinePlusa621002
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
Part of a series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Timeline
2019
2020
2021
2022
2023
Locations
By country and territory
By conveyance
International response
National responses
Medical response
Vaccines
Current vaccines
Variants
Variants of concern
Other variants
Economic impact and recession
By country
By sport
Impacts
Long COVID
Society
Politics
virus icon COVID-19 portal

The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in humans aged six months,[49] twelve years, or eighteen years and older. It provides protection against COVID-19, which is caused by infection by the SARS-CoV-2 virus.[42][2][22][14]

It is designed to be administered in two or three 0.5-mL doses given by intramuscular injection, primarily into the deltoid muscle, at an interval of at least 28 days apart.[33][50][51][52] The World Health Organization advises an eight-week interval between doses to optimize efficacy. Additional booster doses are approved in some regions to maintain immunity. Clinical trials and real-world data have demonstrated the vaccine's high efficacy, with significant effectiveness observed two weeks post-administration of the second dose, offering 94% protection against Covid and robust defense against severe cases. The vaccine's efficacy spans various demographics, including age, sex, and those with high-risk medical conditions.

It is an mRNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[53] In August and September 2022, bivalent versions of the vaccine (Moderna COVID-19 Vaccine, Bivalent) containing elasomeran/elasomeran 0-omicron (Spikevax Bivalent Zero/Omicron)[54] were authorized for use as booster doses in individuals aged 18 or older in the United Kingdom,[55][56] Switzerland,[57] Australia,[58] Canada,[59][60] the European Union,[2] and the United States.[61][62][63][64][65][66] The second component of the version of the bivalent vaccine used in the United States[67] is based on the Omicron BA.4/BA.5 variant,[61] while the second component of the bivalent vaccine version used in other countries is based on the Omicron BA.1 variant.[2][54][56][55][60] The vaccine's effectiveness against variants has been extensively studied, indicating varying degrees of protection. For instance, during the prevalence of the Delta variant, effectiveness against infection slightly decreased over time. The vaccine's longevity and continuous protection are under study, with ongoing research focusing on its duration of effectiveness, which remains partially undetermined as of the latest updates.

The safety profile of the vaccine is favorable, with common side effects including injection site pain, fatigue, and headaches. Severe reactions like anaphylaxis are exceedingly rare. Concerns regarding myocarditis, have been identified but are typically mild and manageable. The vaccine's formulation utilizes mRNA technology, encapsulated within lipid nanoparticles to ensure cellular uptake and immune system response.

  1. ^ a b "Spikevax- covid-19 vaccine, mrna injection, suspension". DailyMed. 1 January 2022. Archived from the original on 18 June 2022. Retrieved 17 June 2022.
  2. ^ a b c d e "Spikevax (previously COVID-19 Vaccine Moderna) EPAR". European Medicines Agency (EMA). 4 January 2021. Archived from the original on 1 February 2022. Retrieved 31 January 2022.
  3. ^ "Takeda Announces Approval of Moderna's COVID-19 Vaccine in Japan" (Press release). Takeda. 21 May 2021. Archived from the original on 23 December 2021. Retrieved 29 May 2021.
  4. ^ a b c d e Cite error: The named reference CA COVID-19 authorizations was invoked but never defined (see the help page).
  5. ^ "Elasomeran for prevention of COVID-19". Australian Prescriber. 44 (5): 172. October 2021. doi:10.18773/austprescr.2021.048. PMC 8542485. PMID 34728884. Archived from the original on 14 May 2022. Retrieved 14 May 2022.
  6. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  7. ^ a b "Spikevax". Therapeutic Goods Administration (TGA). 9 August 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.
  8. ^ a b "Spikevax (elasomeran) Covid-19 Vaccine Product Information Licence" (PDF). Therapeutic Goods Administration (TGA). 18 August 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.
  9. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  10. ^ Cite error: The named reference AU COVID-19 vaccines regulatory status was invoked but never defined (see the help page).
  11. ^ "COVID-19 vaccine: Spikevax (elasomeran)". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 October 2023.
  12. ^ "Summary For Artg Entry: 370599 Spikevax (elasomeran) Covid-19 Vaccine 0.2 Mg/Ml Suspension For Injection Vial" (PDF). Therapeutic Goods Administration (TGA). Retrieved 28 August 2021.[dead link‍]
  13. ^ Cite error: The named reference TGA provisional approval was invoked but never defined (see the help page).
  14. ^ a b Cite error: The named reference TGA provisional approval 2 was invoked but never defined (see the help page).
  15. ^ "AusPAR: Elasomeran". Therapeutic Goods Administration (TGA). 23 February 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  16. ^ "AusPAR: Elasomeran (mRNA-1273)". Therapeutic Goods Administration (TGA). 9 December 2021. Archived from the original on 24 March 2022. Retrieved 24 March 2022.
  17. ^ Cite error: The named reference Spikevax Bivalent Original/Omicron APMDS was invoked but never defined (see the help page).
  18. ^ "Spikevax bivalent Original/Omicron BA.4-5". Therapeutic Goods Administration (TGA). 23 February 2023. Archived from the original on 24 February 2023. Retrieved 8 April 2023.
  19. ^ "Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022". Therapeutic Goods Administration (TGA). 31 August 2022. Retrieved 17 September 2023.
  20. ^ Rosário M (26 June 2023). "Anvisa aprova vacina bivalente da Moderna para Covid-19". O Globo (in Brazilian Portuguese). Archived from the original on 22 May 2024. Retrieved 21 June 2024.
  21. ^ "Anvisa aprova registro da vacina Spikevax monovalente". Brazilian Health Regulatory Agency (in Brazilian Portuguese). 6 March 2024. Retrieved 21 June 2024.
  22. ^ a b "Moderna Spikevax COVID-19 vaccines". Health Canada. 12 September 2023. Archived from the original on 15 September 2023. Retrieved 15 September 2023.
  23. ^ "Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)". Health Canada. 23 December 2020. Archived from the original on 23 December 2020. Retrieved 23 December 2020.
  24. ^ "Regulatory Decision Summary - COVID-19 Vaccine Moderna". Health Canada. 27 August 2021. Archived from the original on 27 August 2021. Retrieved 28 August 2021.
  25. ^ "Spikevax (elasomeran mRNA vaccine) Monograph" (PDF). Archived from the original (PDF) on 3 December 2021.
  26. ^ "Regulatory Decision Summary - Spikevax". Health Canada. 13 November 2020. Archived from the original on 17 September 2021. Retrieved 18 September 2021.
  27. ^ "Summary Basis of Decision (SBD) for Spikevax". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  28. ^ "Summary Basis of Decision (SBD) for Spikevax XBB.1.5". Drug and Health Products Portal. 1 September 2012. Retrieved 11 December 2023.
  29. ^ "Summary of Product Characteristics for Spikevax". Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021. Archived from the original on 18 February 2021. Retrieved 29 August 2021.
  30. ^ "Conditions of Authorisation for COVID-19 Vaccine Moderna". Medicines and Healthcare products Regulatory Agency (MHRA). 8 January 2021. Archived from the original on 18 February 2021. Retrieved 29 August 2021.
  31. ^ "Regulatory approval of Spikevax (formerly COVID-19 Vaccine Moderna)". Medicines and Healthcare products Regulatory Agency (MHRA). 8 January 2021. Archived from the original on 28 August 2021. Retrieved 29 August 2021.
  32. ^ "Summary of the Public Assessment Report for Spikevax". Medicines and Healthcare products Regulatory Agency (MHRA). 19 February 2021. Archived from the original on 22 April 2021. Retrieved 29 August 2021.
  33. ^ a b "Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older" (PDF). Centers for Disease Control and Prevention (CDC). 11 July 2022. Archived from the original (PDF) on 14 August 2021. Retrieved 14 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  34. ^ "Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years Through 17 Years of Age" (PDF). Centers for Disease Control and Prevention (CDC). 11 July 2022. Archived (PDF) from the original on 16 July 2022. Retrieved 14 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  35. ^ "Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 6 Years through 11 Years of Age" (PDF). Centers for Disease Control and Prevention (CDC). 11 July 2022. Archived (PDF) from the original on 16 July 2022. Retrieved 14 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  36. ^ "Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 6 Months Through 5 Years of Age" (PDF). Centers for Disease Control and Prevention (CDC). 11 July 2022. Archived (PDF) from the original on 16 July 2022. Retrieved 14 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  37. ^ a b Cite error: The named reference FDA PR 20230911 was invoked but never defined (see the help page).
  38. ^ "FDA Takes Key Action by Approving Second COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 31 January 2022. Archived from the original on 31 January 2022. Retrieved 31 January 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  39. ^ "Spikevax and Moderna COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 17 June 2022. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  40. ^ Cite error: The named reference FDA PR 20220617 was invoked but never defined (see the help page).
  41. ^ Cite error: The named reference EUA fact sheet was invoked but never defined (see the help page).
  42. ^ a b "Moderna COVID-19 Vaccine- cx-024414 injection, suspension". DailyMed. 17 June 2022. Archived from the original on 18 June 2022. Retrieved 17 June 2022.
  43. ^ "Moderna COVID-19 Vaccine Emergency Use Authorization" (PDF). U.S. Food and Drug Administration (FDA). 17 June 2022. Archived from the original on 14 August 2021. Retrieved 17 June 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  44. ^ Cite error: The named reference EU approval was invoked but never defined (see the help page).
  45. ^ Cite error: The named reference Spikevax EC Union Register was invoked but never defined (see the help page).
  46. ^ Cite error: The named reference EMA PR 20220916 was invoked but never defined (see the help page).
  47. ^ "Spikevax Product information". Union Register of medicinal products. Archived from the original on 24 January 2021. Retrieved 3 March 2023.
  48. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  49. ^ Mandavilli A (19 June 2022). "CDC recommends COVID-19 vaccines for children under 5". The New York Times. Archived from the original on 21 June 2022. Retrieved 21 June 2022.
  50. ^ "Moderna COVID-19 Vaccine". Dosing & Administration. Infectious Diseases Society of America. 4 January 2021. Archived from the original on 20 December 2020. Retrieved 5 January 2021.
  51. ^ Cite error: The named reference FDA PR 20210812 was invoked but never defined (see the help page).
  52. ^ Cite error: The named reference CDC immunocompromised was invoked but never defined (see the help page).
  53. ^ Cite error: The named reference Baden was invoked but never defined (see the help page).
  54. ^ a b "Moderna Announces Clinical Update on Bivalent COVID-19 Booster Platform". Moderna (Press release). 19 April 2022. Archived from the original on 6 May 2022. Retrieved 7 May 2022.
  55. ^ a b "First bivalent COVID-19 booster vaccine approved by UK medicines regulator" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 15 August 2022. Archived from the original on 16 August 2022. Retrieved 16 August 2022.
  56. ^ a b "Regulatory approval of Spikevax bivalent Original/Omicron booster vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 15 August 2022. Archived from the original on 16 August 2022. Retrieved 16 August 2022.
  57. ^ "Swissmedic approves first bivalent COVID-19 booster vaccine in Switzerland". Swissmedic (Press release). 29 August 2022. Archived from the original on 29 August 2022. Retrieved 1 September 2022.
  58. ^ "TGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults" (Press release). Therapeutic Goods Administration. 30 August 2022. Archived from the original on 1 September 2022. Retrieved 1 September 2022.
  59. ^ "Regulatory Decision Summary - Spikevax Bivalent". Health Canada. 1 September 2022. Archived from the original on 1 September 2022. Retrieved 1 September 2022.
  60. ^ a b Boisvert N (1 September 2022). "Health Canada approves updated Moderna vaccine for Omicron variant". CBC News. Archived from the original on 1 September 2022. Retrieved 1 September 2022.
  61. ^ a b "Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose" (Press release). U.S. Food and Drug Administration (FDA). 31 August 2022. Archived from the original on 1 September 2022. Retrieved 1 September 2022.
  62. ^ "CDC Recommends the First Updated COVID-19 Booster" (Press release). U.S. Centers for Disease Control and Prevention (CDC). 1 September 2022. Archived from the original on 2 September 2022. Retrieved 1 September 2022.
  63. ^ "COVID-19 Vaccine Tracker: Moderna: mRNA-1273". McGill University. Archived from the original on 1 February 2022.
  64. ^ "Moderna COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 7 July 2021. Archived from the original on 23 January 2021. Retrieved 5 August 2021.
  65. ^ Stevis-Gridneff M (6 January 2021). "The E.U. drug regulator approves the Moderna vaccine". The New York Times. Archived from the original on 6 August 2021. Retrieved 5 August 2021.
  66. ^ "Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates". Moderna, Inc. (Press release). 5 August 2021. Archived from the original on 6 August 2021. Retrieved 5 August 2021.
  67. ^ "Moderna Completes Application to U.S. Food and Drug Administration For Emergency Use Authorization of Omicron-targeting Bivalent COVID-19 Booster Vaccine, mRNA-1273.222". Moderna, Inc. 23 August 2022. Archived from the original on 25 September 2022. Retrieved 25 September 2022.