1. Why am I being given COMIRNATY Omicron XBB.1.5?

COMIRNATY Omicron XBB.1.5 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 Omicron XBB.1.5 contains the active ingredient raxtozinameran. For more information, see Section 1. Why am I being given COMIRNATY Omicron XBB.1.5? in the full CMI.

2. What should I know before I am given COMIRNATY Omicron XBB.1.5?

You should not be given COMIRNATY Omicron XBB.1.5 if you have had an allergic reaction to any of the ingredients in the vaccine. See list at the end of the CMI. Check with your doctor if you have had: a severe allergic reaction or breathing problems after any other vaccine or after being given COMIRNATY or COMIRNATY Omicron XBB.1.5 vaccines in the past; fainted following 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 a blood thinning medicine. 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 Omicron XBB.1.5 should not be given to infants under 6 months of age. For more information, see Section 2. What should I know before I am given COMIRNATY Omicron XBB.1.5? 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 Omicron XBB.1.5?

COMIRNATY Omicron XBB.1.5 will be given as an injection into the muscle of your upper arm or thigh by a doctor, nurse or pharmacist. For children and adults 5 years of age and older, you will be given one dose followed by a second dose at least 21 days later as 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 as a part of the primary vaccination. A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine. You may receive additional dose(s) at least 3 months after the previous dose. For more information, see Section 4. How will I be given COMIRNATY Omicron XBB.1.5? in the full CMI.

5. What should I know while being given COMIRNATY Omicron XBB.1.5?

For more information, see Section 5. What should I know while being given COMIRNATY Omicron XBB.1.5? 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^® OMICRON XBB.1.5

Active ingredient: raxtozinameran

Consumer Medicine Information (CMI)

This leaflet provides important information about using COMIRNATY Omicron XBB.1.5. 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 Omicron XBB.1.5.

Where to find information in this leaflet:

1. Why am I being given COMIRNATY Omicron XBB.1.5?

COMIRNATY Omicron XBB.1.5 contains the active ingredient raxtozinameran.

COMIRNATY Omicron XBB.1.5 is an mRNA (messenger ribonucleic acid) vaccine.

COMIRNATY Omicron XBB.1.5 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 Omicron XBB.1.5 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 Omicron XBB.1.5?

Warnings

COMIRNATY Omicron XBB.1.5 should not be given:

1. if you are allergic to raxtozinameran 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 or COMIRNATY Omicron XBB.1.5 vaccines 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. 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 Omicron XBB.1.5 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 Omicron XBB.1.5 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 Omicron XBB.1.5.

4. How will I be given COMIRNATY Omicron XBB.1.5?

• COMIRNATY Omicron XBB.1.5 will be given as an injection into the muscle of your upper arm or thigh 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 the vaccine 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 the vaccine.
• Additional dose(s) of COMIRNATY Omicron XBB.1.5 may be given at least 3 months after the primary vaccination for people 5 years of age and older.

5. What should I know while being given COMIRNATY Omicron XBB.1.5?

Things you should know

• If you receive one dose of COMIRNATY Omicron XBB.1.5, 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 Omicron XBB.1.5 at least 28 days after the second dose as part of the primary vaccination.
• Additional dose(s) of COMIRNATY Omicron XBB.1.5 may be given at least 3 months after the previous dose 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 Omicron XBB.1.5 affects you.

Some of the side effects of COMIRNATY Omicron XBB.1.5 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 Omicron XBB.1.5 contains

Do not receive this vaccine if you are allergic to any of these ingredients.

What COMIRNATY Omicron XBB.1.5 looks like

COMIRNATY Omicron XBB.1.5 (Grey, Orange and Maroon cap) is a white to off-white frozen suspension.

COMIRNATY Omicron XBB.1.5 (Blue and Yellow cap) is a clear to slightly opalescent solution.

COMIRNATY Omicron XBB.1.5 – Single dose Glass Prefilled Syringes and Single dose Plastic Prefilled Syringes is a white to off-white suspension. Yellow cap vial (For Age 6 months to less than 5 Years):

COMIRNATY Omicron XBB.1.5 (Yellow cap) is provided in packs of 10 and 195 in clear glass vials with yellow flip-off caps. After dilution, each dose is 0.3 mL and each vial contains 3 doses of vaccine (0.48 mL fill). AUST R 428610

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

COMIRNATY Omicron XBB.1.5 (Maroon cap) is provided in packs of 10 and 195 in 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 419332

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

COMIRNATY Omicron XBB.1.5 (Light or Dark Blue cap) is provided in packs of 10 in clear glass vials with blue flip-off caps. No dilution required. Each dose is 0.3 mL.

Each single dose vial (Light Blue) contains 1 dose of vaccine (0.48 mL fill). AUST R 419371.

Each multidose vial (Dark Blue) contains 6 doses of vaccine (2.25 mL fill). AUST R 419372

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

COMIRNATY Omicron XBB.1.5 (Orange cap) is provided in packs of 10 and 195 in 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 419331

Grey cap vial (For Ages 12 Years and older):

COMIRNATY Omicron XBB.1.5 (Light or Dark Grey cap) is provided in packs of 10 in clear glass vials with grey flip-off caps. No dilution required. Each dose is 0.3 mL.

Each single dose vial (Light Grey) contains 1 dose of vaccine (0.48 mL fill). AUST R 419370

Each multidose vial (Dark Grey) contains 6 doses of vaccine (2.25 mL fill). AUST R 419330

Single dose Glass Prefilled Syringes (For Ages 12 Years and older):

COMIRNATY Omicron XBB.1.5 – Single dose Glass Prefilled Syringes is provided in packs of 10 in clear glass syringes with a rigid cap. No dilution is required. Each dose is 0.3 mL.

Each single dose glass syringe contains 1 dose of vaccine (0.418 mL fill). AUST R 442810.

Single dose Plastic Prefilled Syringes (For Ages 12 Years and older):

COMIRNATY Omicron XBB.1.5 – Single dose Plastic Prefilled Syringes is provided in packs of 10 in transparent plastic syringes with a rigid cap. No dilution is required. Each dose is 0.3 mL.

Each single dose plastic syringe contains 1 dose of vaccine (0.432 mL fill). AUST R 442811.

Not all presentations may be available.

Who distributes COMIRNATY Omicron XBB.1.5

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 August 2024.

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