Identification
- Summary
AstraZeneca COVID-19 Vaccine is a two-dose replication-deficient adenovirus vector vaccine used to prevent COVID-19 caused by SARS-CoV-2.
- Brand Names
- Vaxzevria
- Generic Name
- AstraZeneca COVID-19 Vaccine
- DrugBank Accession Number
- DB15656
- Background
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-2.3,5 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).1,4 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-2.4 The University of Oxford struck a development and distribution deal with AstraZeneca in May 20206 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.5,7
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.9
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 2021.3 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 55.3
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- AZD-1222
- AZD1222
- ChAdOx1 nCoV-19
- ChAdOx1-S [recombinant]
- Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19
- Covishield
- External IDs
- AZD 1222
- AZD-1222
- AZD1222
Pharmacology
- 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-19.5
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
The AstraZeneca COVID-19 Vaccine comprises two intramuscularly-administered doses given 4 to 12 weeks apart. Vaccine efficacy in the prevention of all COVID-19 cases has been estimated as ~67%, while efficacy in the prevention of serious COVID-19 (including hospitalizations and death) is 100%.10 Exploratory analyses revealed a vaccine efficacy that appeared to increase with increasing dosing interval between the first and second doses10 - up to 80% when administered ≥12 weeks apart - though the significance and validity of this observation is currently unclear.
In November 2021, Health Canada released a public advisory regarding a rare risk of immune thrombocytopenia associated with the AstraZeneca COVID-19 vaccine (Vaxzevria) - patients are advised to seek immediate medical treatment if they experience any of the following after vaccination: unexplained bleeding, unexplained bruising, small purple spots beyond the site of vaccination, shortness of breath, chest pain, leg pain and/or swelling, and persistent abdominal pain.11
- Mechanism of action
The AstraZeneca COVID-19 Vaccine is a replication-deficient (i.e. inactivated) chimpanzee adenovirus vector - specifically the ChAdOx1 vector - encoding a trimeric pre-fusion form of the SARS-CoV-2 spike (S) protein.5 Following intramuscular administration these spike proteins are expressed locally, allowing the immune system to mount a neutralizing antibody/cellular immune response. This initial exposure and priming of the immune system subsequently provides protection against future infection.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
There are no direct data regarding overdosage with this vaccine - in the event of overdosage, prescribing information recommends supportive and symptomatic treatment.5
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Not Available
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- International/Other Brands
- Vaxzevria (AstraZeneca)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Astrazeneca Covid-19 Vaccine Injection, suspension 50000000000 {VP}/0.5mL Intramuscular AstraZeneca Pharmaceuticals LP 2020-12-22 Not applicable US 
Covid-19 Vaccine Astrazeneca Injection, suspension 250000000 Inf. U Intramuscular Astra Zeneca Ab 2021-03-17 Not applicable EU 
Covid-19 Vaccine Astrazeneca Injection, suspension 250000000 Inf. U Intramuscular Astra Zeneca Ab 2021-03-17 Not applicable EU Covishield Solution 50000000000 vp / 0.5 mL Intramuscular Verity Pharmaceuticals Inc. 2021-03-03 Not applicable Canada 
Vaxzevria Solution 50000000000 vp / 0.5 mL Intramuscular Astra Zeneca Not applicable Not applicable Canada Vaxzevria Solution 50000000000 vp / 0.5 mL Intramuscular Astra Zeneca 2021-04-01 Not applicable Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Astrazeneca Covid-19 Vaccine AstraZeneca COVID-19 Vaccine (50000000000 {VP}/0.5mL) Injection, suspension Intramuscular AstraZeneca Pharmaceuticals LP 2020-12-22 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- B5S3K2V0G8
- CAS number
- 2420395-83-9
References
- General References
- Alharbi NK, Padron-Regalado E, Thompson CP, Kupke A, Wells D, Sloan MA, Grehan K, Temperton N, Lambe T, Warimwe G, Becker S, Hill AVS, Gilbert SC: ChAdOx1 and MVA based vaccine candidates against MERS-CoV elicit neutralising antibodies and cellular immune responses in mice. Vaccine. 2017 Jun 27;35(30):3780-3788. doi: 10.1016/j.vaccine.2017.05.032. Epub 2017 Jun 1. [Article]
- Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ: 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. 2020 Dec 8. pii: S0140-6736(20)32661-1. doi: 10.1016/S0140-6736(20)32661-1. [Article]
- Clinical Trials: A Study of a Candidate COVID-19 Vaccine (COV001) [Link]
- TrialSite News: University of Oxford Commences Clinical Trial for Vaccine Candidate (ChAdOx1 nCoV-19) Targeting COVID-19 [Link]
- Health Canada Product Monograph: AstraZeneca COVID-19 Vaccine [Link]
- TrialSite News: University of Oxford Selects AstraZeneca as its Commercial Partner for its SARS-CoV-2 Vaccine ChAdOx1 nCoV-19 [Link]
- AstraZeneca: Medical Information Site for COVID-19 Vaccine AstraZeneca [Link]
- UK Reg 174: AstraZeneca COVID-19 Vaccine Information for UK Healthcare Professionals [Link]
- EMA PRAC Committee: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets Share [Link]
- EMA Summary of Product Characteristics: AstraZeneca COVID-19 Vaccine for intramuscular injection [Link]
- Health Canada Public Advisory: Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines [Link]
- EMA COVID-19 Vaccine Safety Update: Vaxzevria (Dec 9/21) [Link]
- External Links
- Wikipedia
- COVID-19_vaccine
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Not Yet Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / COVID-19, SARS-CoV-2 1 4 Not Yet Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Vaccine Preventable Diseases 1 4 Recruiting Other Coronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19) 1 4 Recruiting Prevention Chronic Liver Diseases (CLD) / Coronavirus Disease 2019 (COVID‑19) 1 3 Active Not Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 3 Not Yet Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines 1 3 Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) 1 3 Recruiting Prevention Coronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus 1 3 Withdrawn Prevention Coronavirus Disease 2019 (COVID‑19) 1 2 Active Not Recruiting Health Services Research Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, suspension Intramuscular 50000000000 {VP}/0.5mL Injection, suspension Intramuscular 250000000 Inf. U Solution Intramuscular 50000000000 vp / 0.5 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at April 01, 2020 15:25 / Updated at December 17, 2021 21:23