User:Mr. Ibrahem/Moderna COVID-19 vaccine

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Mr. Ibrahem/Moderna COVID-19 vaccine
INN: Elasomeran
Vials of the Moderna COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Pronunciation/məˈdɜːrnə/ mə-DUR-nə[1]
Trade namesSpikevax[2]
Other namesmRNA-1273, CX-024414, COVID-19 mRNA vaccine Moderna, TAK-919, COVID-19 vaccine moderna intramuscular injection[3]
AHFS/Drugs.comMonograph
MedlinePlusa621002
License data
Pregnancy
category
Routes of
administration		Intramuscular
Drug classCOVID-19 vaccine[2]
Legal status
Legal status

Moderna COVID‑19 vaccine, known by the generic name elasomeran and brand name Spikevax, is a COVID-19 vaccine.[2][26] It is used in people over the age of eleven or seventeen, depending on the jurisdiction, to provide protection against COVID-19.[25][2][27] It was initially found to be 94% effective.[27] It is given as two or three 0.5 mL doses by injection into a muscle at least 28 days apart.[25]

Most side effects are mild to moderate and resolve within a few days.[2] These may include pain at the injection site, tiredness, fever, swollen lymph nodes, headache, and muscle pains.[2] Rare side effects may include anaphylaxis, facial palsy, pericarditis, and myocarditis.[2] There is no evidence of harm with use in pregnancy.[4] It is an mRNA vaccine, composed of nucleoside-modified mRNA (modRNA) encoding the spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[28]

The vaccine received emergency use authorization (EUA) in the United States in December 2020 and was approved for medical use in Europe in January of 2021.[25][2] It is authorized for use at some level in at least 86 countries as of 2022.[29][30] In 2020 it was being sold to governments at about 35 USD per dose.[31] It was developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).[32] It was the first COVID-19 vaccine to be studied in humans.[33]

References[edit]

  1. ^ Moderna (23 October 2019). mRNA-3704 and Methylmalonic Acidemia (Video). YouTube. Archived from the original on 28 February 2021. Retrieved 19 January 2021.
  2. ^ a b c d e f g h i j "Spikevax (previously COVID-19 Vaccine Moderna) EPAR". European Medicines Agency (EMA). 4 January 2021. Archived from the original on 28 June 2021. Retrieved 29 June 2021.
  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 3 January 2022.
  4. ^ a b "Spikevax". Therapeutic Goods Administration (TGA). 9 August 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.
  5. ^ 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.
  6. ^ "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.{{cite web}}: CS1 maint: url-status (link)
  7. ^ Cite error: The named reference TGA provisional approval was invoked but never defined (see the help page).
  8. ^ Cite error: The named reference TGA provisional approval 2 was invoked but never defined (see the help page).
  9. ^ "Covax Facility" (in Portuguese). Federal government of Brazil. Brazilian Health Regulatory Agency. 25 June 2021. Archived from the original on 13 November 2021. Retrieved 20 November 2021.
  10. ^ Cite error: The named reference CA COVID-19 authorizations was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference CA Spikevax was invoked but never defined (see the help page).
  12. ^ "Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)". COVID-19 vaccines and treatments portal. 23 December 2020. Archived from the original on 23 December 2020. Retrieved 23 December 2020.
  13. ^ "Regulatory Decision Summary - COVID-19 Vaccine Moderna". Health Canada. Archived from the original on 27 August 2021. Retrieved 28 August 2021.
  14. ^ "Archive copy" (PDF). Archived (PDF) from the original on 2021-12-03. Retrieved 2022-01-03.{{cite web}}: CS1 maint: archived copy as title (link)
  15. ^ "Regulatory Decision Summary - Spikevax". Health Canada. 13 November 2020. Archived from the original on 17 September 2021. Retrieved 18 September 2021.
  16. ^ "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.
  17. ^ "Regulatory approval of Spikevax (formerly 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.
  18. ^ "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.
  19. ^ "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.
  20. ^ "FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on 17 March 2021. Retrieved 18 December 2020.
  21. ^ "Moderna COVID-19 Vaccine – cx-024414 injection, suspension". DailyMed. Archived from the original on 4 April 2021. Retrieved 20 December 2020.
  22. ^ Moderna COVID-19 Vaccine Emergency Use Authorization (PDF). U.S. Food and Drug Administration (FDA) (Report). 12 August 2021. Archived from the original on 14 August 2021. Retrieved 13 August 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  23. ^ "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). 16 July 2021. Archived (PDF) from the original on 14 August 2021.
  24. ^ Cite error: The named reference EU approval was invoked but never defined (see the help page).
  25. ^ a b c d "COVID-19 Vaccine (Moderna) Monograph for Professionals". Drugs.com. Retrieved 28 January 2022.
  26. ^ "TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran". Therapeutic Goods Administration (TGA) (Press release). 24 June 2021. Archived from the original on 27 June 2021. Retrieved 29 June 2021.
  27. ^ a b "Moderna COVID-19 vaccine". Health Canada. 23 December 2020. Archived from the original on 27 August 2021. Retrieved 28 August 2021.
  28. ^ Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. (February 2021). "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine". The New England Journal of Medicine. 384 (5): 403–416. doi:10.1056/NEJMoa2035389. PMC 7787219. PMID 33378609.
  29. ^ "Moderna COVID-19 vaccine - WikiProjectMed". mdwiki.org. The New York Times. Januarary 28 2022. Archived from the original on 28 January 2022. Retrieved 28 January 2022. {{cite news}}: Check date values in: |date= (help)
  30. ^ "COVID-19 Vaccine Tracker: Moderna: mRNA-1273". McGill University. Archived from the original on 2021-12-13. Retrieved 2022-01-03.
  31. ^ Jr, Berkeley Lovelace (5 August 2020). "Moderna is pricing coronavirus vaccine at $32 to $37 per dose for some customers". CNBC. Archived from the original on 13 January 2022. Retrieved 28 January 2022.
  32. ^ Clouse A (24 November 2020). "Fact check: Moderna vaccine funded by government spending, with notable private donation". USA Today. Archived from the original on 25 April 2021. Retrieved 25 April 2021.
  33. ^ Whittacker, Elizabeth; Heath, Paul T. (2021). "27. COVID-19 in children and COVID-19 vaccines". In Vesikari, Timo; Damme, Pierre Van (eds.). Pediatric Vaccines and Vaccinations: A European Textbook (Second ed.). Switzerland: Springer. p. 299. ISBN 978-3-030-77172-0. Archived from the original on 2022-01-29. Retrieved 2022-01-29.
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