NAV

AstraZeneca COVID-19 Vaccine

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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Associated Conditions
Contraindications & Blackbox Warnings
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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
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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.
DrugInteraction
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interactions in your software
AbataceptThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of AstraZeneca COVID-19 Vaccine can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
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Food Interactions
Not Available

Products

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International/Other Brands
Vaxzevria (AstraZeneca)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Astrazeneca Covid-19 VaccineInjection, suspension50000000000 {VP}/0.5mLIntramuscularAstraZeneca Pharmaceuticals LP2020-12-22Not applicableUS flag
Covid-19 Vaccine AstrazenecaInjection, suspension250000000 Inf. UIntramuscularAstra Zeneca Ab2021-03-17Not applicableEU flag
Covid-19 Vaccine AstrazenecaInjection, suspension250000000 Inf. UIntramuscularAstra Zeneca Ab2021-03-17Not applicableEU flag
CovishieldSolution50000000000 vp / 0.5 mLIntramuscularVerity Pharmaceuticals Inc.2021-03-03Not applicableCanada flag
VaxzevriaSolution50000000000 vp / 0.5 mLIntramuscularAstra ZenecaNot applicableNot applicableCanada flag
VaxzevriaSolution50000000000 vp / 0.5 mLIntramuscularAstra Zeneca2021-04-01Not applicableCanada flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Astrazeneca Covid-19 VaccineAstraZeneca COVID-19 Vaccine (50000000000 {VP}/0.5mL)Injection, suspensionIntramuscularAstraZeneca Pharmaceuticals LP2020-12-22Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
B5S3K2V0G8
CAS number
2420395-83-9

References

General References
  1. 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]
  2. 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]
  3. Clinical Trials: A Study of a Candidate COVID-19 Vaccine (COV001) [Link]
  4. TrialSite News: University of Oxford Commences Clinical Trial for Vaccine Candidate (ChAdOx1 nCoV-19) Targeting COVID-19 [Link]
  5. Health Canada Product Monograph: AstraZeneca COVID-19 Vaccine [Link]
  6. TrialSite News: University of Oxford Selects AstraZeneca as its Commercial Partner for its SARS-CoV-2 Vaccine ChAdOx1 nCoV-19 [Link]
  7. AstraZeneca: Medical Information Site for COVID-19 Vaccine AstraZeneca [Link]
  8. UK Reg 174: AstraZeneca COVID-19 Vaccine Information for UK Healthcare Professionals [Link]
  9. 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]
  10. EMA Summary of Product Characteristics: AstraZeneca COVID-19 Vaccine for intramuscular injection [Link]
  11. Health Canada Public Advisory: Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines [Link]
  12. EMA COVID-19 Vaccine Safety Update: Vaxzevria (Dec 9/21) [Link]
Wikipedia
COVID-19_vaccine

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / COVID-19, SARS-CoV-21
4Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
4Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Vaccine Preventable Diseases1
4RecruitingOtherCoronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19)1
4RecruitingPreventionChronic Liver Diseases (CLD) / Coronavirus Disease 2019 (COVID‑19)1
3Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines1
3Active Not RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19)1
3Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
3Not Yet RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines1
3RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntramuscular50000000000 {VP}/0.5mL
Injection, suspensionIntramuscular250000000 Inf. U
SolutionIntramuscular50000000000 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