User:Mr. Ibrahem/Pfizer–BioNTech COVID-19 vaccine

Source: Wikipedia, the free encyclopedia.
Mr. Ibrahem/Pfizer–BioNTech COVID-19 vaccine
INN: tozinameran
SARS-CoV-2
Vaccine typemRNA
Clinical data
PronunciationTozinameran: /ˌtoʊzɪˈnæmərən/ TOH-zih-NAM-ər-ən
Trade namesComirnaty[1]
Other namesBNT162b2, COVID-19 mRNA vaccine (nucleoside-modified)
AHFS/Drugs.comMonograph
MedlinePlusa621003
License data
Pregnancy
category
Routes of
administration		Intramuscular
Drug classCOVID-19 vaccine[1]
Legal status
Legal status

Pfizer–BioNTech COVID-19 vaccine, known by the generic name tozinameran and brand name Comirnaty, is a COVID-19 vaccine.[1] It is used in people over the age of four, eleven, or fifteen years depending on the jurisdictions, to provide protection against COVID-19.[1][20][21] It was initially found to be 95% effective.[1] It is given as at least two doses, by injection into a muscle, at least 21 days apart.[1]

Most side effects are mild to moderate and resolve within a few days.

facial palsy, pericarditis, and myocarditis.[1] There is no evidence of harm with use in pregnancy.[22][23] 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.[24]

The vaccine received

stringent regulatory authority.[29][30] As of September 2021, more than 1.5 billion doses have been shipped worldwide.[31]

References

  1. ^ a b c d e f g h i j k l m "EPAR2022". European Medicines Agency (EMA). Archived from the original on 19 December 2021. Retrieved 24 October 2021. {{cite web}}: |archive-date= / |archive-url= timestamp mismatch; 18 December 2021 suggested (help)
  2. ^ a b "Comirnaty". Therapeutic Goods Administration (TGA). 25 January 2021. Archived from the original on 1 February 2021. Retrieved 25 January 2021.
  3. ^ "Comirnaty (BNT162b2 [mRNA]) COVID-19 Vaccine Product Information" (PDF). Therapeutic Goods Administration (TGA). Archived from the original on 2 February 2021. Retrieved 25 January 2021.
  4. ^ "AusPAR: BNT162b2 (mRNA)". Therapeutic Goods Administration (TGA). 23 July 2021. Archived from the original on 24 January 2021. Retrieved 22 October 2021.
  5. ^ "COVID-19 vaccine: Pfizer Australia - Comirnaty BNT162b2 (mRNA) - approved for use in individuals 12 years and older". Therapeutic Goods Administration (TGA). 27 August 2021. Archived from the original on 23 July 2021. Retrieved 22 October 2021.
  6. ^ "TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group". Therapeutic Goods Administration (TGA). 23 July 2021. Archived from the original on 22 October 2021. Retrieved 22 October 2021.
  7. ^ "Regulatory Decision Summary - Comirnaty". Health Canada. Archived from the original on 19 September 2021. Retrieved 18 September 2021.
  8. ^ "Pfizer-BioNTech Comirnaty COVID-19 vaccine". Health Canada. 9 December 2020. Archived from the original on 5 June 2021. Retrieved 18 September 2021.
  9. ^ "Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications". Health Canada. 17 September 2020. Archived from the original on 24 March 2021. Retrieved 17 September 2021.
  10. ^ "Regulatory approval of Pfizer/BioNTech vaccine for COVID-19". Medicines and Healthcare products Regulatory Agency (MHRA). 27 September 2021. Archived from the original on 19 January 2021. Retrieved 24 October 2021.
  11. ^ "Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 10 December 2020. Archived from the original on 15 March 2021. Retrieved 21 December 2020.
  12. ^ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 31 December 2020. Archived from the original on 26 February 2021. Retrieved 8 January 2021.
  13. ^ "Comirnaty". U.S. Food and Drug Administration (FDA). 23 August 2021. STN: 125742. Archived from the original on 3 December 2021. Retrieved 23 August 2021.
  14. ^ a b "Pfizer-Biontech COVID-19 Vaccine- bnt162b2 injection, suspension". DailyMed. Archived from the original on 16 November 2020. Retrieved 24 October 2021.
  15. ^ "FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age". U.S. Food and Drug Administration (FDA) (Press release). 29 October 2021. Archived from the original on 3 November 2021. Retrieved 4 November 2021.
  16. ^ "FDA Approves First COVID-19 Vaccine" (Press release). U.S. Food and Drug Administration (FDA). 23 August 2021. Archived from the original on 23 August 2021. Retrieved 23 August 2021.
  17. ^ "Pfizer–BioNTech COVID-19 Vaccine EUA Letter of Authorization" (PDF). U.S. Food and Drug Administration (FDA). 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.
  18. ^ "Pfizer–BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 28 September 2021. Archived (PDF) from the original on 2 March 2021. Retrieved 24 October 2021.
  19. ^ "Pfizer-BioNTech COVID-19 Vaccine- bnt162b2 injection, suspension". DailyMed. Archived from the original on 21 October 2021. Retrieved 24 October 2021.
  20. ^ "Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine". Medicines and Healthcare products Regulatory Agency (MHRA). 8 December 2020. Archived from the original on 30 May 2021. Retrieved 29 May 2021.
  21. ^ "Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine". Health Canada. Archived from the original on 12 May 2021. Retrieved 11 May 2021.
  22. ^ "Sars-cov-2 mrna (tozinameran) vaccine Use During Pregnancy". Drugs.com. Archived from the original on 1 December 2021. Retrieved 29 January 2022.
  23. ^ Administration, Australian Government Department of Health Therapeutic Goods (25 January 2021). "COMIRNATY". Therapeutic Goods Administration (TGA). Archived from the original on 1 February 2021. Retrieved 29 January 2022.
  24. PMID 33053279
    .
  25. ^ a b "COVID-19 Vaccine (Pfizer-BioNTech) Monograph for Professionals". Drugs.com. Retrieved 29 January 2022.
  26. ^ Holder, Josh (29 January 2021). "Tracking Coronavirus Vaccinations Around the World". The New York Times. Archived from the original on 22 December 2021. Retrieved 28 January 2022.
  27. doi:10.1136/bmj.n281
    .
  28. ^ Browne R (11 November 2020). "What you need to know about BioNTech – the European company behind Pfizer's Covid-19 vaccine". CNBC. Archived from the original on 4 March 2021. Retrieved 14 January 2021.
  29. ^ "UK medicines regulator gives approval for first UK COVID-19 vaccine" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 2 December 2020. Archived from the original on 17 March 2021. Retrieved 2 December 2020.
  30. ^ Boseley S, Halliday J (2 December 2020). "UK approves Pfizer/BioNTech Covid vaccine for rollout next week". The Guardian. Archived from the original on 2 December 2020. Retrieved 14 December 2020.
  31. ^ "Pfizer and BioNTech expand collaboration with U.S. to provide 500 million additional COVID-19 vaccine doses at not-for-profit price for donation to poorest countries". 22 September 2021. Archived from the original on 22 September 2021.
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