COVID-19 Vaccine AstraZeneca

This vaccine has provisional registration in Australia as a vaccine used to protect people against COVID-19. The decision to
approve this vaccine has been made on the basis of promising preliminary results from clinical studies. More evidence is required
to be submitted when available to fully confirm the benefit and safety of the vaccine for this use.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this vaccine, speak to your healthcare provider
(e.g. doctor, nurse or pharmacist).

 This vaccine is new. Please report side effects. See the full CMI for further details.

1. Why am I being given COVID-19 Vaccine AstraZeneca?

COVID-19 Vaccine AstraZeneca contains the active ingredient ChAdOx1-S. This vaccine is used to protect people aged 18 years
and older against COVID-19. For more information, see Section 1. Why am I using COVID-19 Vaccine AstraZeneca? in the full CMI.

2. What should I know before I am given COVID-19 Vaccine AstraZeneca?

You should not receive COVID-19 Vaccine AstraZeneca if you have ever had an allergic reaction to COVID-19 Vaccine AstraZeneca
or any of the ingredients listed at the end of the CMI.
Talk to your healthcare provider if you have any other medical conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
COVID-19 Vaccine AstraZeneca should not be given to children under 18 years. For more information, see Section 2. What should
I know before I use COVID-19 Vaccine AstraZeneca? in the full CMI.

3. What if I am taking, have recently taken or might take other medicines or vaccines?
Medicines (including other vaccines) that may impact whether you should be given this vaccine or not are listed in Section 3.
What if I am taking other medicines? in the full CMI.

4. How will I be given COVID-19 Vaccine AstraZeneca?

COVID-19 Vaccine AstraZeneca will be given to you by a healthcare provider. It is injected into a muscle (usually in the upper
arm). You will receive 2 (0.5 mL per dose) injections. The second injection can be given between 4 and 12 weeks after the first
injection. More instructions can be found in Section 4. How do I use COVID-19 Vaccine AstraZeneca? in the full CMI.

5. What should I know while using COVID-19 Vaccine AstraZeneca?

General As with any vaccine, COVID-19 Vaccine AstraZeneca may not protect everyone who is vaccinated from
COVID-19. It is not yet known how long people who receive the vaccine will be protected for.
Driving or using COVID-19 Vaccine AstraZeneca has no known effect on the ability to drive and use machines. However,
machines side effects listed in section 6 may impact your ability to drive and use machines. If you feel unwell, do not
drive or use machines.
For more information, see Section 5. What should I know about being given this COVID-19 Vaccine? in the full CMI.

6. Are there any side effects?

Most side effects are mild to moderate in nature and resolve within a few days. These include tenderness, pain, warmth,
redness, itching or swelling where the injection is given; Generally feeling unwell; Feeling tired (fatigue); Chills, fever or feeling
feverish; Headache; Feeling sick (nausea); Muscle pain/ache, joint pain. For more information, including what to do if you have
any side effects, see Section 6. Are there any side effects? in the full CMI.

COVID-19 Vaccine AstraZeneca 1

 This vaccine is subject to additional monitoring. This will allow quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side effects to your doctor or other healthcare provider,
or directly at www.tga.gov.au/reporting-problems.

COVID-19 Vaccine AstraZeneca

Active ingredient: ChAdOx1-S
This vaccine has provisional registration in Australia as a vaccine used to protect people against COVID-19. The decision to
approve this vaccine has been made on the basis of promising preliminary results from clinical studies. More evidence is
required to be submitted when available to fully confirm the benefit and safety of the vaccine for this use.

Check with your healthcare provider before

Consumer Medicine Information (CMI) vaccination if:
This leaflet provides important information about COVID-
19 Vaccine AstraZeneca. You should also speak to your  You have ever had a severe allergic reaction
healthcare provider (e.g. doctor, nurse or pharmacist) if (anaphylaxis) after any other vaccine injection;
you would like further information or if you have any  Your immune system does not work properly
concerns or questions about using this COVID-19 Vaccine. (immunodeficiency) or are taking medicines that
weaken the immune system (such as high-dose
Where to find information in this leaflet: corticosteroids, immunosuppressants or cancer
medicines);
1. Why am I being given COVID-19 Vaccine  You currently have a severe infection with a high
AstraZeneca? temperature (over 38°C);
2. What should I know before I am given this COVID-19  You have a problem with bleeding or bruising, or if
vaccine
you are taking a blood thinning medicine
3. What if I am taking, have recently taken or might
(anticoagulant);
take other medicines or vaccines?
 You have any other medical conditions
4. How I am given this COVID-19 Vaccine?
 You take any medicines for any other condition
5. What should I know about being given this COVID-19
including any recent or planned vaccines
Vaccine?
6. Are there any side effects? After vaccination you may be at risk of developing certain
7. Product details side effects. It is important you understand these risks and
how to monitor for them. See additional information
1. Why am I being given COVID-19 Vaccine under Section 6. Are there any side effects?
AstraZeneca? Pregnancy and breastfeeding
COVID-19 Vaccine AstraZeneca contains the active Check with your healthcare provider if you are pregnant or
ingredient ChAdOx1-S. This vaccine is used to protect breast-feeding, think you may be pregnant or are planning
people aged 18 years and older against COVID-19. to have a baby. There are limited data on the use of
COVID-19 is caused by a virus called coronavirus COVID-19 Vaccine AstraZeneca in pregnant or
(SARS-CoV-2). breastfeeding women. Your healthcare provider will
discuss with you whether you can be given the vaccine.
COVID-19 Vaccine AstraZeneca stimulates the body’s
natural defences (immune system). It causes the body to Children and adolescents
produce its own protection (antibodies) against the virus.
This will help to protect you against COVID-19 in the No data are currently available on the use of COVID-19
future. None of the ingredients in this vaccine can cause Vaccine AstraZeneca in children and adolescents younger
COVID-19. than 18 years of age.

2. What should I know before I am given 3. What if I am taking, have recently taken
this COVID-19 vaccine or might take other medicines or
vaccines?
Warnings
Tell your healthcare provider if you are taking, have
You should not receive COVID-19 Vaccine recently taken, or might take, any other vaccines or
AstraZeneca if: medicines including any medicines, vitamins or
supplements that you buy without a prescription from
 you are allergic to this vaccine or any of the your pharmacy, supermarket or health food shop.
ingredients listed at the end of this leaflet.
 Always check the ingredients to make sure you can
use this vaccine.

COVID-19 Vaccine AstraZeneca 2

Medicines (including other vaccines) that may impact Driving or using machines
whether you should be given this vaccine or not include
the following (see also Section 2 above): Be careful before you drive or use any machines or tools
until you know how this vaccine affects you.
 medicines that weaken the immune system (such as
high-dose corticosteroids, immunosuppressants or COVID-19 Vaccine AstraZeneca has no known effect on the
cancer medicines); ability to drive and use machines. However, side effects
 blood thinning medicines (anticoagulant) listed in section 6 may impact your ability to drive and use
machines. If you feel unwell, do not drive or use machines.
 any other vaccine including any other COVID-19
vaccines Looking after your vaccine
Check with your healthcare provider if you are not sure Your healthcare provider is responsible for storing this
about what vaccines, medicines, vitamins or supplements vaccine and disposing of any unused product correctly.
you are taking or have recently taken and if these may
affect this COVID-19 Vaccine.
6. Are there any side effects?
4. How I am given this COVID-19 Vaccine? All vaccines can have side effects. If you do experience any
side effects, most of them are mild to moderate in nature
How COVID-19 Vaccine AstraZeneca is given and resolve within a few days. However, some side effects
may need medical attention.
COVID-19 Vaccine AstraZeneca will be given to you by a
healthcare provider. It is injected into a muscle (usually in See the information below and, if you need to, ask your
the upper arm). healthcare provider if you have any further questions
about side effects.
You will receive 2 (0.5 mL per dose) injections. You will be
told when you need to return for your second injection of Less serious side effects
COVID-19 Vaccine AstraZeneca.
Less serious side effects What to do
The second injection can be given between 4 and 12 weeks
after the first injection.  Tenderness, pain, Speak to your
When COVID-19 Vaccine AstraZeneca is given for the first warmth, redness, itching healthcare provider if
injection, COVID-19 Vaccine AstraZeneca (and not another or swelling where the you have any of these
vaccine against COVID-19) should be given for the second injection is given less serious side
injection to complete vaccination course.  Generally feeling unwell effects and they worry
 Feeling tired (fatigue) you.
If you forget to get your second injection  Chills, fever or feeling Medicines containing
feverish paracetamol can be
If you forget to go back at the scheduled time, ask your
healthcare provider for advice. It is important that you  Headache taken if you need
return for your second injection of COVID-19 Vaccine  Feeling sick (nausea) relief from side effects
AstraZeneca.  Muscle pain/ache, joint such as pain and/or
pain fever.
If you use too much COVID-19 Vaccine AstraZeneca
As COVID-19 Vaccine AstraZeneca is given under the close
supervision of a healthcare provider it is unlikely that you Serious side effects
will be given too much.
Serious side effects What to do
If you are concerned that you have been given too much
All injectable vaccines have the Tell your healthcare
COVID-19 Vaccine AstraZeneca, tell your healthcare
potential for an allergic reaction provider straight
provider immediately.
after you are injected. away, or go straight
You should do this even if there are no signs of to the Emergency
Some of the symptoms of an
discomfort or poisoning. Department at your
allergic reaction may include:
nearest hospital if
5. What should I know about being given  rash, itching or hives on the you notice any of
skin these serious side
this COVID-19 Vaccine?  swelling of the face, lips, effects.
As with any vaccine, COVID-19 Vaccine AstraZeneca may tongue or other parts of
not protect everyone who is vaccinated from COVID-19. It the body
is not yet known how long people who receive the vaccine  shortness of breath,
will be protected for. wheezing or difficulty
breathing
 fainting, dizziness, feeling
lightheaded (due to a drop
in blood pressure)

COVID-19 Vaccine AstraZeneca 3

Tell your healthcare provider if you notice anything else
that may be making you feel unwell.
Other side effects not listed here may occur in some
people.
Reporting side effects
After you have received medical advice for any side effects
you experience, you can report side effects to the
Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems. By reporting side
effects, you can help provide more information on the
safety of this vaccine.

7. Product details
This vaccine is only available with a doctor's prescription.
What COVID-19 Vaccine AstraZeneca contains
Active ingredient One dose (0.5 mL) contains:
(main ingredient) ChAdOx1-S* 5x1010 viral
particles (vp)
Other ingredients histidine, histidine
(inactive ingredients) hydrochloride monohydrate,
sodium chloride, magnesium
chloride hexahydrate, disodium
edetate, sucrose, ethanol
absolute, polysorbate 80 and
water for injections.
* Recombinant, replication-deficient chimpanzee
adenovirus vector encoding the SARS-CoV-2 Spike
glycoprotein. The vaccine is manufactured using material
originally sourced from a human embryo (Human Embryo
Kidney cells: HEK293).
Do not take this vaccine if you are allergic to any of these
ingredients.
This product contains genetically modified organisms
(GMOs).
COVID-19 Vaccine AstraZeneca does not contain any
preservatives and the vial stopper is not made with
natural rubber latex.
What this vaccine looks like
COVID-19 Vaccine AstraZeneca is available in a 5mL (10
dose) vial in packs of 10 vials (Aust R 349072).
Sponsor
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
For COVID-19 Vaccine AstraZeneca enquiries contact
1800 343 949

This leaflet was prepared on 16 February 2021.

© AstraZeneca, 2021
Doc ID-004490139 v1

COVID-19 Vaccine AstraZeneca 4