Overview
The AstraZeneca COVID-19 Vaccine (previously known as ChAdOx1 nCoV-19 or AZD1222) is one of several vaccines developed in 2020 for the prevention of COVID-19 caused by SARS-CoV-2. The ChAdOx1 viral vector was developed at the University of Oxford and has been investigated as a potential vector for vaccines against another human coronavirus, Middle Eastern respiratory syndrome coronavirus (MERS-CoV). The ChAdOx1 nCoV-19 vaccine, produced in a partnership between The University of Oxford's Jenner Institute and Italian pharmaceutical manufacturer Advent Srl, consists of a replication-deficient adenovirus capable of producing the spike (S) protein of SARS-CoV-2, allowing for the formation of endogenous antibodies against these proteins and, consequently, against SARS-CoV-2. The University of Oxford struck a development and distribution deal with AstraZeneca in May 2020 which paved the way for the vaccine's subsequent approval and usage in dozens of regions across the globe, including Canada, Mexico, the UK, the EU, and Australia, amongst others. In March 2021, several EU member countries halted the administration of AstraZeneca's COVID-19 Vaccine due to signals of an increased risk of blood clots associated with thrombocytopenia, including the development of cerebral venous sinus thrombosis (CVST). Upon review, the European Medicines Agency (EMA) determined that the vaccine was not associated with a higher overall risk of blood clots, but that it may be associated with very rare instances of blood clots in association with thrombocytopenia - a causal link with the vaccine has not been proven, but is possible and requires further analysis. Despite these concerns, the EMA concluded its review by reiterating that the benefits of the vaccine in the prevention of COVID-19 - a condition which itself leads to blood clots - continue to outweigh the risks associated with its administration. A phase I/II single-blinded, randomized, placebo-controlled trial to investigate the safety, efficacy, and immunogenicity of the vaccine began in April 2020 with an expected completion date of October 2021. The trial is taking place in the UK, where the vaccine will be administered intramuscularly to healthy adult volunteers between the ages of 18 and 55.
Indication
The AstraZeneca COVID-19 Vaccine is indicated for the active immunization of individuals 18 years of age and older for the prevention of COVID-19.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2024/01/03 | Phase 4 | Completed | |||
2023/02/08 | Phase 3 | Completed | Botswana Harvard AIDS Institute Partnership | ||
2022/11/02 | Phase 3 | Completed | |||
2021/11/19 | N/A | Completed | |||
2021/09/27 | Phase 4 | Terminated | |||
2021/07/22 | Phase 2 | Completed | |||
2021/05/20 | Phase 2 | Active, not recruiting | |||
2021/04/01 | N/A | Active, not recruiting | University Medicine Greifswald | ||
2020/09/29 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
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