1. Why am I being given COMIRNATY?

COMIRNATY is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults, infants and children from 6 months of age and older. COMIRNATY contains the active ingredient tozinameran. For more information, see Section 1. Why am I being given COMIRNATY? in the full CMI.

2. What should I know before I am given COMIRNATY?

You should not be given COMIRNATY if you've had an allergic reaction to any of the ingredients in COMIRNATY. See list at the end of the CMI. Check with your doctor if you've had: a severe allergic reaction or breathing problems after any other vaccine or after being given COMIRNATY in the past; fainted after any needle injection; a severe illness or infection with high fever; a weakened immune system or are on a medicine that affects your immune system; a bleeding disorder, bruise easily or are on blood thinners. 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. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. COMIRNATY should not be given to children under 6 months. For more information, see Section 2. What should I know before I am given COMIRNATY? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription. Tell your doctor or pharmacist if you have recently received any other vaccine. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

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. For anyone 5 years of age and older, one dose will be given followed by a second dose at least 21 days later as the primary vaccination. If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose as part of the primary vaccination. For children 6 months to less than 5 years of age, a third dose will be given at least 8 weeks after the second dose as a part of the primary vaccination. You may receive a booster dose at least 6 months after the primary vaccination and a subsequent booster at least 4 months after a previous booster. For more information, see Section 4. How will I be given COMIRNATY? in the full CMI.

5. What should I know while being given COMIRNATY?

For more information, see Section 5. What should I know while being given COMIRNATY? in the full CMI.

6. Are there any side effects?

Very common side effects of COMIRNATY include pain/swelling at injection site, tiredness, headache, muscle pain, chills, joint pain and fever. 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.

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COMIRNATY® COVID-19 VACCINE

Active ingredient: tozinameran

Consumer Medicine Information (CMI)

This leaflet provides important information about using COMIRNATY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about receiving COMIRNATY.

Where to find information in this leaflet:

1. Why am I being given COMIRNATY?

COMIRNATY contains the active ingredient tozinameran. 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, infants and children from 6 months 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?

Warnings

COMIRNATY should not be given:

1. if you are allergic to tozinameran 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.

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?

Very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported after vaccination with COMIRNATY. The cases have mostly occurred within two weeks following vaccination, more often after the second vaccination, and more often, but not always, in younger men. There have been cases in women. Fewer cases of myocarditis and pericarditis have been reported in children aged 5 to 11 years compared to children aged 12 to 17 years. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur. Sometimes the symptoms of myocarditis and pericarditis may not be specific and could include tiredness, dizziness, nausea and vomiting, abdominal pain, swelling, and cough.

You may develop a temporary, stress-related response associated with the process of receiving your injection. This may include dizziness, fainting, sweating, increased heart rate and/or anxiety. If you start to feel faint at any time during the process of receiving your injection, let your doctor, nurse or pharmacist know and take actions to avoid falling and injuring yourself, such as sitting or lying down.

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.

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 infants under 6 months of age.

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.
• For primary vaccination, you will be given two doses. One dose followed by a second dose at least 21 days later. If you miss the second dose, ask your doctor for advice.
• If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose as part of the primary vaccination.
• For infants and children 6 months to less than 5 years of age, a third dose will be given at least 8 weeks after the second dose to complete the primary vaccination.
• A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given COMIRNATY.
• A booster dose of COMIRNATY may be given at least 6 months after the primary vaccination for people 5 years of age and older.
• A subsequent booster of COMIRNATY may be given at least 4 months after a previous booster.

5. What should I know while being given COMIRNATY?

Things you should know

• If you receive one dose of COMIRNATY, you should continue to receive the same vaccine to complete the primary vaccination schedule.
• If you are immunocompromised, you may receive a third dose of COMIRNATY at least 28 days after the second dose as part of the primary vaccination.
• A booster dose of COMIRNATY may be given at least 6 months after the primary vaccination for people 5 years of age and older.
• You may not be protected against COVID-19 disease until at least seven days after primary vaccination.
• You may not be protected if you only receive one dose, so it is very important that you complete your primary vaccination.

Driving or using machines

Be careful before you drive, cycle 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, cycle or use machines.

Storage of the vaccine

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.

Very common side effects

Common side effects

Uncommon side effects

Rare side effects

Other side effects (frequency unknown)

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.

Maroon cap vial (For Age 6 months to less than 5 Years):

COMIRNATY For Age 6 months to less than 5 Years is provided in packs of 10 and 195 in multidose clear glass vials with maroon flip-off caps. After dilution, each dose is 0.2 mL and each vial contains 10 doses of vaccine (0.4 mL fill).

AUST R 393433

Orange cap vial (For Age 5 to less than 12 Years):

COMIRNATY For Age 5 to less than 12 Years is provided in packs of 10 and 195 in multidose clear glass vials with orange flip-off caps. After dilution, each dose is 0.2 mL and each vial contains 10 doses of vaccine (1.3 mL fill).

AUST R 377111

Grey cap vial (Do Not Dilute for Ages 12 Years and older):

COMIRNATY For Ages 12 Years and older is provided in packs of 10 and 195 in multidose clear glass vials with grey flip-off caps. Each dose is 0.3 mL and each vial contains 6 doses of vaccine (2.25 mL fill).

AUST R 377110.

Not all presentations may be available.

Who distributes COMIRNATY

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Number: 1800 675 229

www.pfizermedinfo.com.au

COMIRNATY® is a registered trademark of BioNTech SE. Used under license.

This leaflet was prepared in June 2024.

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