Oxford–AstraZeneca COVID-19 vaccine

"Oxford/AstraZeneca", "Oxford vaccine", "AstraZeneca vaccine", and "Covishield" redirect here. For other vaccination topics, see AstraZeneca, Weatherall Institute of Molecular Medicine, and Oxford Vaccine Group.

Oxford–AstraZeneca COVID-19 vaccine
A vial of COVID-19 Vaccine AstraZeneca
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesVaxzevria,[1] Covishield[2][3]
Other namesAZD1222,[4][5]
ChAdOx1 nCoV-19,[6]
ChAdOx1-S,[7]
COVID-19 Vaccine AstraZeneca,[8][9]
AstraZeneca COVID-19 Vaccine,[10]
AZD2816[11]
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Full list of Oxford–AstraZeneca vaccine authorisations
Identifiers
CAS Number
DrugBank
UNII
KEGG
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The Oxford–AstraZeneca COVID‑19 vaccine, sold under the brand names Covishield[31] and Vaxzevria[1][32] among others, is a viral vector vaccine for the prevention of COVID-19. It was developed in the United Kingdom by Oxford University and British-Swedish company AstraZeneca,[33][34][35] using as a vector the modified chimpanzee adenovirus ChAdOx1.[36] The vaccine is given by intramuscular injection. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose and 81.3% after the second dose.[37] A study in Scotland found that, for symptomatic COVID-19 infection after the second dose, the vaccine is 81% effective against the Alpha variant (lineage B.1.1.7) and 61% against the Delta variant (lineage B.1.617.2).[38]

The vaccine is stable at refrigerator temperatures and has a good safety profile, with side effects including injection-site pain, headache, and nausea, all generally resolving within a few days.[39][40] More rarely, anaphylaxis may occur; the UK Medicines and Healthcare products Regulatory Agency (MHRA) has 268 reports out of some 21.2 million vaccinations as of 14 April 2021.[40] In very rare cases (around 1 in 100,000 people), the vaccine has been associated with an increased risk of blood clots when in combination with low levels of blood platelets (embolic and thrombotic events after COVID-19 vaccination).[41][42][1] According to the European Medicines Agency, as of 4 April 2021, a total of 222 cases of blood clots had been recorded among 34 million people who had been vaccinated in the European Economic Area (a percentage of 0.0007%).[43]

On 30 December 2020, the vaccine was first approved for use in the UK vaccination programme,[26][44][45] and the first vaccination outside of a trial was administered on 4 January 2021.[46] The vaccine has since been approved by several medicine agencies worldwide, such as the European Medicines Agency (EMA),[1][29] and the Australian Therapeutic Goods Administration (provisional approval in February 2021),[7][47] and was approved for an Emergency Use Listing by the World Health Organization (WHO).[48] More than 3 billion doses of the vaccine were supplied to countries worldwide.[49] Some countries have limited its use to elderly people at higher risk for severe COVID-19 illness due to concerns over the very rare side effects of the vaccine in younger individuals.[50]

The vaccine is no longer in production. AstraZeneca withdrew its marketing authorizations for the vaccine from the European market in March 2024,[1] and worldwide by May 2024.[51]

  1. ^ a b c d e f "Vaxzevria (previously COVID-19 Vaccine AstraZeneca) EPAR". European Medicines Agency (EMA). 25 January 2021. Archived from the original on 21 April 2021. Retrieved 27 March 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ^ Cite error: The named reference CA About was invoked but never defined (see the help page).
  3. ^ "Already produced 40–50 million dosages of Covishield vaccine, says Serum Institute". The Hindu. 28 December 2020. Archived from the original on 20 April 2021. Retrieved 30 December 2020.
  4. ^ Cite error: The named reference AstraZeneca_PR was invoked but never defined (see the help page).
  5. ^ "AstraZeneca COVID-19 Vaccine (AZD1222)" (PDF). AstraZeneca. 27 January 2021. Archived (PDF) from the original on 27 January 2021. Retrieved 7 March 2021.
  6. ^ "AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine". AstraZeneca (Press release). 30 April 2020. Archived from the original on 16 November 2020. Retrieved 13 January 2021.
  7. ^ a b c d "COVID-19 Vaccine AstraZeneca PI". Therapeutic Goods Administration (TGA). Archived from the original on 31 July 2021. Retrieved 31 July 2021.
  8. ^ a b "COVID-19 Vaccine AstraZeneca". Therapeutic Goods Administration (TGA). 16 February 2021. Archived from the original on 18 March 2021. Retrieved 16 February 2021.
  9. ^ a b "Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca". Medicines and Healthcare products Regulatory Agency (MHRA). 30 December 2020. Archived from the original on 9 March 2021. Retrieved 4 January 2021.
  10. ^ a b "Regulatory Decision Summary – AstraZeneca COVID-19 Vaccine". Health Canada. 26 February 2021. Archived from the original on 11 March 2021. Retrieved 26 February 2021.
  11. ^ "First COVID-19 variant vaccine AZD2816 Phase II/III trial participants vaccinated" (Press release). AstraZeneca. 27 June 2021. Archived from the original on 27 June 2021. Retrieved 24 July 2021.
  12. ^ "Prescribing medicines in pregnancy database". Therapeutic Goods Administration (TGA). Archived from the original on 20 December 2016. Retrieved 13 May 2022.
  13. ^ "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.
  14. ^ "Summary for ARTG Entry: 349072 COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial".
  15. ^ "COVID-19 vaccine: AstraZeneca ChAdOx1-S". Therapeutic Goods Administration (TGA). 27 August 2021. Archived from the original on 23 October 2021. Retrieved 22 October 2021.
  16. ^ "AusPAR: ChAdOx-1-S". Therapeutic Goods Administration (TGA). 17 February 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  17. ^ "AstraZeneca) Labelling Exemption 2021". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 19 March 2023. Retrieved 9 April 2023.
  18. ^ "Brazil grants full approval to Oxford vaccine, orders Sputnik". Brasilia: France 24. Agence France-Presse. 12 March 2021. Archived from the original on 16 March 2021. Retrieved 13 March 2021.
  19. ^ "Anvisa aprova registro da vacina da Fiocruz/AstraZeneca e de medicamento contra o coronavírus" [Anvisa approves registration of Fiocruz/AstraZeneca vaccine and drug against the coronavirus] (in Portuguese). Federal government of Brazil. Brazilian Health Regulatory Agency. 20 November 2021. Archived from the original on 20 November 2021. Retrieved 20 November 2021.
  20. ^ "Regulatory Decision Summary - Vaxzevria". Health Canada. Archived from the original on 26 November 2021. Retrieved 26 November 2021.
  21. ^ "AstraZeneca COVID-19 Vaccine monograph" (PDF). AstraZeneca. 26 February 2021. Archived (PDF) from the original on 30 March 2021. Retrieved 5 March 2021.
  22. ^ "Summary Basis of Decision (SBD) for Vaxzevria". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  23. ^ "Vaxzevria (ChAdOx1-S [recombinant])". Health Canada. 26 February 2021. Archived from the original on 1 June 2022. Retrieved 31 May 2022.
  24. ^ "Covishield (ChAdOx1-S [recombinant])". COVID-19 vaccines and treatments portal. 26 February 2021. Archived from the original on 1 June 2022. Retrieved 31 May 2022.
  25. ^ "Vaxzevria, suspension for injection, COVID 19 Vaccine (ChAdOx1 S [recombinant]) - Summary of Product Characteristics (SmPC)". (emc). 1 July 2022. Archived from the original on 1 July 2022. Retrieved 1 July 2022.
  26. ^ a b "Conditions of Authorisation for COVID-19 Vaccine AstraZeneca". Medicines and Healthcare products Regulatory Agency (MHRA). 30 December 2020. Archived from the original on 18 February 2021. Retrieved 4 January 2021.
  27. ^ "COVID-19 vaccines: authorised". European Medicines Agency (EMA). 11 January 2021. Archived from the original on 29 June 2022. Retrieved 31 October 2022.
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  29. ^ a b "European Commission authorises third safe and effective vaccine against COVID-19". European Commission (Press release). Archived from the original on 10 February 2021. Retrieved 29 January 2021.
  30. ^ "아스트라제네카社 코로나19 백신 품목허가" [AstraZeneca's Corona 19 vaccine product license]. 식품의약품안전처 (in Korean). 10 February 2021. Archived from the original on 10 February 2021. Retrieved 10 February 2021.
  31. ^ "Covishield and Covaxin: What we know about India's Covid-19 vaccines". BBC News. 4 March 2021. Archived from the original on 7 March 2021. Retrieved 8 March 2021.
  32. ^ "AstraZeneca vaccine renamed 'Vaxzevria'". The Brussels Times. 30 March 2021. Archived from the original on 31 March 2021. Retrieved 6 April 2021.
  33. ^ "Investigating a Vaccine Against COVID-19". ClinicalTrials.gov (Registry). United States National Library of Medicine. 26 May 2020. NCT04400838. Archived from the original on 11 October 2020. Retrieved 14 July 2020.
  34. ^ "A Phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19". EU Clinical Trials Register (Registry). European Union. 21 April 2020. EudraCT 2020-001228-32. Archived from the original on 5 October 2020. Retrieved 3 August 2020.
  35. ^ O'Reilly P (May 2020). "A Phase III study to investigate a vaccine against COVID-19". ISRCTN (Registry). doi:10.1186/ISRCTN89951424. ISRCTN89951424.
  36. ^ Voysey M, Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. (January 2021). "Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK". Lancet. 397 (10269): 99–111. doi:10.1016/S0140-6736(20)32661-1. ISSN 0140-6736. PMC 7723445. PMID 33306989.
  37. ^ Cite error: The named reference Voysev_Feb21 was invoked but never defined (see the help page).
  38. ^ Cite error: The named reference effectiveness-scotland was invoked but never defined (see the help page).
  39. ^ Cite error: The named reference voxcom was invoked but never defined (see the help page).
  40. ^ a b "Coronavirus Vaccine : Summary of Yellow Card reporting" (PDF). Archived (PDF) from the original on 16 March 2021. It is known from the clinical trials that the more common side effects for both vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms)
  41. ^ "AstraZeneca's COVID-19 vaccine: benefits and risks in context". European Medicines Agency (EMA) (Press release). 23 April 2021. Archived from the original on 23 April 2021. Retrieved 23 April 2021.
  42. ^ Cite error: The named reference EMA20210325ANNEX was invoked but never defined (see the help page).
  43. ^ "AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low platelets". European Medicines Agency (EMA) (Press release). 7 April 2021. Archived from the original on 20 May 2021. Retrieved 9 April 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  44. ^ "Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK". BBC News Online. 30 December 2020. Archived from the original on 30 December 2020. Retrieved 30 December 2020.
  45. ^ "Second COVID-19 vaccine authorised by medicines regulator". GOV.UK (Press release). 30 December 2020. Archived from the original on 15 March 2021. Retrieved 6 March 2021.
  46. ^ "Covid: Brian Pinker, 82, first to get Oxford-AstraZeneca vaccine". BBC News Online. 4 January 2021. Archived from the original on 18 April 2021. Retrieved 4 January 2021.
  47. ^ "Vaccines undergoing evaluation". Therapeutic Goods Administration (TGA). 20 July 2021. Archived from the original on 26 January 2022. Retrieved 30 July 2021. AstraZeneca Pty Ltd, ChAdOx1-S [recombinant], Viral vector -- Provisional determination notice -- Provisionally approved on 15 February 2021
  48. ^ "Coronavirus disease (COVID-19): Vaccines" (Press release). World Health Organization (WHO). Archived from the original on 18 December 2020. Retrieved 6 March 2021.
  49. ^ "AstraZeneca withdraws Covid-19 vaccine, citing low demand". CNN. 8 May 2024. Retrieved 9 May 2024.
  50. ^ "Spain, Belgium and Italy restrict AstraZeneca Covid vaccine to older people". The Guardian. 8 April 2021. Archived from the original on 9 April 2021. Retrieved 11 April 2021.
  51. ^ "AstraZeneca to withdraw COVID-19 vaccine globally, Telegraph reports". Reuters. 7 May 2024.
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