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.
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.
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.
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.
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.
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.
For more information, see Section 5. What should I know about being given this COVID-19 Vaccine? in the full CMI.
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.
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.
This leaflet provides important information about COVID19 Vaccine AstraZeneca. You should also speak to your healthcare provider (e.g. doctor, nurse or pharmacist) if you would like further information or if you have any concerns or questions about using this COVID-19 Vaccine. Where to find information in this leaflet
COVID-19 is caused by a virus called coronavirus (SARS-CoV-2).
COVID-19 Vaccine AstraZeneca stimulates the body’s natural defenses (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.
After vaccination you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Check with your healthcare provider if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Your healthcare provider will discuss with you whether you can be given the vaccine.
No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.
Tell your healthcare provider if you are taking, have recently taken, or might take, any other vaccines or medicines including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
COVID-19 Vaccine AstraZeneca will be given to you by a healthcare provider. It is injected into a muscle (usually in the upper arm).
The second injection can be given between 4 and 12 weeks after the first injection.
When COVID-19 Vaccine AstraZeneca is given for the first injection, COVID-19 Vaccine AstraZeneca (and not another vaccine against COVID-19) should be given for the second injection to complete vaccination course.
If you forget to go back at the scheduled time, ask your healthcare provider for advice. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca.
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.
COVID-19 Vaccine AstraZeneca has no known effect on the ability to drive and use machines. However, 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.
Your healthcare provider is responsible for storing this vaccine and disposing of any unused product correctly.
All vaccines can have side effects. If you do experience any side effects, most of them are mild to moderate in nature and resolve within a few days. However, some side effects may need medical attention. See the information below and, if you need to, ask your healthcare provider if you have any further questions about side effects.
Medicines containing paracetamol can be taken if you need relief from side effects such as pain and/or fever.
Some of the symptoms of an allergic reaction may include:
Tell your healthcare provider straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Other side effects not listed here may occur in some people.
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.
This vaccine is only available with a doctor’s prescription.
One dose (0.5 mL) contains: ChAdOx1 – S * 5×1010 viral particles (vp)
histidine, histidine 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).
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.
COVID -19 Vaccine AstraZeneca is available in a 5mL (10 dose) vial in packs of 10 vials (Aust R 349072 ).
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Vaccine AstraZeneca enquiries contact
1800 343 949
This leaflet was prepared on 1
6 February 2021.
© AstraZeneca, 2021
Doc ID-004490139 v1
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