1. Why am I being given COMIRNATY?
COMIRNATY contains the active ingredient BNT162b2 [mRNA]. COMIRNATY is an mRNA (messenger ribonucleic acid) vaccine.
COMIRNATY is a vaccine given to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults and adolescents from 16 years of age and older.
COMIRNATY works by triggering your immune system to produce antibodies and blood cells that work against the virus, to protect against COVID-19 disease.
2. What should I know before I am given COMIRNATY?
COMIRNATY should not be given:
- If you are allergic to BNT162b2 [mRNA] or any of the ingredients listed at the end of this leaflet.
Check with your doctor if you have:
- had a severe allergic reaction or breathing problems after any other vaccine or after being given COMIRNATY in the past.
- fainted following any needle injection.
- a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
- a weakened immune system, such as due to HIV infection or are on a medicine that affects your immune system.
- a bleeding disorder, bruise easily or are on a blood thinning medicine.
As with any vaccine, COMIRNATY may not fully protect all those who receive it and it is not known how long you will be protected.
During treatment, 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?
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.
Children and adolescents
COMIRNATY should not be given to children under 16 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Tell your doctor or pharmacist if you have recently received any other vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect, or are affected by, COMIRNATY.
4. How will I be given COMIRNATY?
- COMIRNATY will be given as an injection into the muscle of your upper arm by a doctor, nurse or pharmacist.
- You will be given one dose followed by a second dose at least 21 days later. If you miss the second dose, ask your doctor for advice.
- A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given COMIRNATY.
5. What should I know while being given COMIRNATY?
Things you should know
- If you receive one dose of COMIRNATY, you should receive a second dose of the same vaccine at least 21 days later to complete the vaccination schedule.
- You may not be protected against COVID-19 disease until at least seven days after your second dose.
- You may not be protected if you only receive one dose, so a second dose is important.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how COMIRNATY affects you. Some of the side effects of COMIRNATY may temporarily affect your ability to drive or use machines.
Storage of the vaccine
COMIRNATY is stored at -90°C to -60°C. It must be kept in the original package in order to protect from light.
A doctor, nurse or pharmacist will prepare the injection for you before you are given it.
Getting rid of any unwanted vaccine
A doctor, nurse or pharmacist will dispose of any unused vaccine.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Tell your doctor or pharmacist 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
What COMIRNATY contains
Do not receive this vaccine if you are allergic to any of these ingredients.
What COMIRNATY looks like
COMIRNATY is a white to off-white suspension provided in a multidose clear glass vial.
After dilution, each vial contains 6 doses of vaccine.
AUST R 346290.
Who distributes COMIRNATY
Pfizer Australia Pty Ltd
Medical Information www.pfizermedinfo.com.au or
Toll Free Number: 1800 675 229
This leaflet was prepared in January 2021.
Published by MIMS March 2021