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AstraZeneca COVID-19 vaccine: What

you should know

What you should know

Authorization information

Continued monitoring

Many potential drugs and vaccines for use against COVID-19 are being
evaluated in Canada and around the world. We’re closely tracking all
potential drugs and vaccines in development.

You can search the complete list of applications received for COVID-19-
related drugs and vaccines and their status.

On this page
About the AstraZeneca COVID-19 vaccine
Ingredients
How it works
How it’s given
Possible side effects
 Vaccine safety after authorization

About the AstraZeneca COVID-19 vaccine

The AstraZeneca COVID-19 vaccine (ChAdOx1-S) is used to prevent
COVID-19. This disease is caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). Canada has authorized 2 manufacturers of
the ChAdOx1-S vaccine:

AstraZeneca (brand name AstraZeneca COVID-19 Vaccine)

Verity Pharmaceuticals and Serum Institute of India (SII) in
collaboration with AstraZeneca (brand name COVISHIELD Vaccine)

AstraZeneca COVID‐19 Vaccine (manufactured by AstraZeneca) and

COVISHIELD (manufactured by Serum Institute of India) are ChAdOx1-S
recombinant vaccines developed by AstraZeneca and Oxford University.
Health Canada has reviewed the manufacturing information for these
vaccines and found them to be comparable.

The vaccine is approved for people who are 18 years of age and older. Its
safety and effectiveness in people younger than 18 years of age have not
yet been established.

Health Canada authorized both applications for this vaccine with

conditions on February 26, 2021, under the interim order respecting the
importation, sale and advertising of drugs for use in relation to COVID-
19.

Find detailed technical information about the AstraZeneca vaccine, such

as the product monograph and our regulatory decision summary, in the
COVID-19 vaccines and treatments regulatory portal.

AstraZeneca regulatory information Verity/SII regulatory information

Ingredients
 Medicinal ingredient
Adenovirus vector vaccine
Non-medicinal ingredients
disodium edetate dihydrate (EDTA)
ethanol
L-histidine
L-histidine hydrochloride monohydrate
magnesium chloride hexahydrate
polysorbate 80
sodium chloride
sucrose
water for injection

How it works
Viral vector-based vaccines use a harmless virus, such as an adenovirus,
as a delivery system. This “vector” virus is not the virus that causes
COVID-19. Adenoviruses are among the viruses that can cause the
common cold. There are many different types of adenoviruses, and many
have been used as delivery systems for other vector-based vaccines for
decades.

When a person is given the vaccine, the vector virus contained within the
vaccine produces the SARS-CoV-2 spike protein. This protein is found on
the surface of the virus that causes COVID-19. This protein will not make
you sick. It does its job and goes away.

Through this process, the body is able to build a strong immune

response against the spike protein without exposing you to the virus that
causes COVID-19.

How it’s given

The vaccine is given by 2 separate injections of 0.5 mL each into the
muscle of the arm. For the vaccine to work best, you need to get 2 doses:
a first dose and then a second dose 4 to 12 weeks later.

Immunity develops over time. It takes about 2 weeks to develop

significant protection against COVID-19. For the greatest protection, you
will need the second dose.

The AstraZeneca COVID-19 vaccine showed an effectiveness of about

62% in preventing symptomatic COVID-19 disease beginning 2 weeks
after the second dose. This effectiveness rate is based on an analysis of
results from participants who had received the 2 dose regimen that will
be used in Canada.

Possible side effects

In general, the side effects observed during the clinical trials are similar
to what you might have with other vaccines.

The side effects that followed vaccine administration in clinical trials were
mild or moderate. They included things like pain at the site of injection,
body chills, feeling tired and feeling feverish.

These are common side effects of vaccines and do not pose a risk to
health.

As with all vaccines, there’s a chance that there will be a serious side
effect, but these are rare. A serious side effect might be something like
an allergic reaction. Speak with your health professional about any
serious allergies or other health conditions you may have before you
receive this vaccine.

Health Canada has conducted a rigorous scientific review of the available

medical evidence to assess the safety of the AstraZeneca COVID-19
vaccine. No major safety concerns have been identified in the data that
we reviewed.

Vaccine safety after authorization

As for all medicines, Health Canada will continue to monitor the safety of
the AstraZeneca COVID-19 vaccine in Canada closely. Along with the
Public Health Agency of Canada and working in close collaboration with
the provinces and territories and the manufacturer, we will monitor for
any adverse events that may develop after immunization.

Once the product is on the market, the manufacturers (AstraZeneca

Canada Inc. and Verity Pharmaceuticals/Serum Institute of India (SII))
are legally required to submit reports of adverse events to Health
Canada.

The manufacturer is planning to follow clinical trial participants for at

least 1 year after the second dose of the vaccine is given. It must
communicate any safety concerns to Health Canada.

To ensure that the benefits of the vaccine continue to outweigh the risks,
we may also impose terms and conditions at any time. For example, we
can require the manufacturer to take further risk mitigation measures.
We can also ask the manufacturer to submit additional safety
information.

Health Canada will continue to review all the available safety data as it
becomes available. We will take appropriate action, if required, to protect
the health and safety of Canadians.

Related links
How to get vaccinated
Adverse events following immunization report
AstraZeneca vaccine regulatory authorization information
 Vaccines and treatments for COVID-19
Vaccines and immunization
List of authorized drugs, vaccines and expanded indications for
COVID-19

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Date modified:
2021-03-12