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.

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

• Coronavirus Disease 2019 (COVID‑19)

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.

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.

Not Available

Food Interactions

Not Available

Products

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Astrazeneca Covid-19 Vaccine	Solution	50000000000 vp / 0.5 mL	Intramuscular	Astra Zeneca	2021-04-01	Not applicable
Astrazeneca Covid-19 Vaccine	Injection, suspension	50000000000 {VP}/0.5mL	Intramuscular	AstraZeneca Pharmaceuticals LP	2020-12-22	Not applicable
Astrazeneca Covid-19 Vaccine	Solution	50000000000 vp / 0.5 mL	Intramuscular	Astra Zeneca	Not applicable	Not applicable
Covid-19 Vaccine Astrazeneca	Injection, suspension	250000000 Inf. U	Intramuscular	Astra Zeneca Ab	2021-03-17	Not applicable
Covid-19 Vaccine Astrazeneca	Injection, suspension	250000000 Inf. U	Intramuscular	Astra Zeneca Ab	2021-03-17	Not applicable
Covishield	Solution	50000000000 vp / 0.5 mL	Intramuscular	Verity Pharmaceuticals Inc.	2021-03-03	Not applicable

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

Categories

Drug Categories

• Experimental Unapproved Treatments for COVID-19

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]

External Links

Wikipedia

COVID-19_vaccine

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
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	Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19)	1
3	Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus	1
3	Suspended	Prevention	Coronavirus Disease 2019 (COVID‑19)	1
2	Not Yet Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19)	2
2	Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19)	1
2, 3	Recruiting	Prevention	Coronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus	1
1	Enrolling by Invitation	Prevention	Infections, Coronavirus	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection, suspension	Intramuscular	50000000000 {VP}/0.5mL
Solution	Intramuscular	50000000000 vp / 0.5 mL
Injection, suspension	Intramuscular	250000000 Inf. U

Prices

Not Available

Patents

Not Available

Properties

State

Not Available

Experimental Properties

Not Available

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Drug created on April 01, 2020 15:25 / Updated on April 16, 2021 04:48