Comirnaty Bivalent BA.1

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about receiving this vaccine, speak to your doctor or pharmacist.

This vaccine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I being given COMIRNATY Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults, 18 years of age and older. COMIRNATY Original/Omicron BA.1 contains the active ingredients tozinameran and riltozinameran. For more information, see Section 1. Why am I being given COMIRNATY Original/Omicron BA.1? in the full CMI.

2. What should I know before I am given COMIRNATY Original/Omicron BA.1?

You should not be given COMIRNATY Original/Omicron BA.1 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 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. As with any vaccine, COMIRNATY Original/Omicron BA.1 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. This vaccine should not be given to adolescents or children under 18 years. For more information, see Section 2. What should I know before I am given COMIRNATY Original/Omicron BA.1? 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 Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 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 at least 5 months after the primary course. A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine. COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist. For more information, see Section 4. How will I be given COMIRNATY Original/Omicron BA.1? in the full CMI.

5. What should I know while being given COMIRNATY Original/Omicron BA.1?

Things you should know	An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older. COMIRNATY Original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary vaccination comprised of another COVID-19 vaccine.
Driving or using machines	Be careful before you drive or use any machines or tools until you know how the vaccine affects you. Some of the side effects of the vaccine may temporarily affect your ability to drive or use machines.

For more information, see Section 5. What should I know while being given COMIRNATY Original/Omicron BA.1? in the full CMI.

6. Are there any side effects?

Very common side effects of COMIRNATY Original/Omicron BA.1 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.

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 directly at www.tga.gov.au/reporting-problems .

Active ingredients: tozinameran and riltozinameran

This vaccine has provisional approval in Australia to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults, 18 years of age and older. This approval has been granted on the basis of short term safety and efficacy data. Evidence of longer term efficacy and safety from ongoing clinical trials and vaccination in the community continues to be gathered and assessed.

Full Consumer Medicine Information (CMI)

This leaflet provides important information about using COMIRNATY Original/Omicron BA.1. 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 Original/Omicron BA.1.

Where to find information in this leaflet:

1. Why am I being given COMIRNATY Original/Omicron BA.1?

2. What should I know before I am given COMIRNATY Original/Omicron BA.1?

3. What if I am taking other medicines?

4. How will I be given COMIRNATY Original/Omicron BA.1?

5. What should I know while being given COMIRNATY Original/Omicron BA.1?

6. Are there any side effects?

7. Product details

1. Why am I being given COMIRNATY Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 contains the active ingredients tozinameran and riltozinameran. COMIRNATY Original/Omicron BA.1 is an mRNA (messenger ribonucleic acid) vaccine.

COMIRNATY Original/Omicron BA.1 is a vaccine given to prevent COVID-19 disease caused by SARS-CoV-2 virus in adults, 18 years of age and older.

COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist.

COMIRNATY Original/Omicron BA.1 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 Original/Omicron BA.1?

Warnings

COMIRNATY Original/Omicron BA.1 should not be given:

1. if you are allergic to tozinameran, riltozinameran 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 occurred in younger men. 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.

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 Original/Omicron BA.1 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 Original/Omicron BA.1 should not be given to adolescents or children under 18 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 Original/Omicron BA.1.

4. How will I be given COMIRNATY Original/Omicron BA.1?

COMIRNATY Original/Omicron BA.1 will be given as an injection into the muscle of your upper arm by a doctor, nurse or pharmacist.

An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older.

A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given COMIRNATY Original/Omicron BA.1.

COMIRNATY Original/Omicron BA.1 is only given as booster doses. For primary vaccination, ask your doctor or pharmacist.

5. What should I know while being given COMIRNATY Original/Omicron BA.1?

Things you should know

An initial dose of COMIRNATY Original/Omicron BA.1 may be given as a booster at least 5 months after the primary vaccination for people 18 years of age and older.

COMIRNATY Original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary vaccination comprised of another COVID-19 vaccine

Driving or using machines

Be careful before you drive or use any machines or tools until you know how COMIRNATY Original/Omicron BA.1 affects you.

Some of the side effects of COMIRNATY Original/Omicron BA.1 may temporarily affect your ability to drive 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

Very common side effects	What to do
pain/swelling at injection site tiredness headache muscle pain chills joint pain fever	Speak to your doctor if you have any of these very common side effects and they worry you.

Common side effects

Common side effects	What to do
redness at injection site nausea	Speak to your doctor if you have any of these common side effects and they worry you.

Uncommon side effects

Uncommon side effects	What to do
enlarged lymph nodes feeling unwell arm pain insomnia decreased appetite excessive sweating night sweats physical weakness and/or lack of energy	Speak to your doctor if you have any of these side effects and they worry you.

Rare side effects

Rare side effects	What to do
temporary one-sided facial drooping	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice this side effect.

Other side effects (frequency unknown)

Other side effects (frequency unknown)	What to do
severe allergic reaction allergic reactions such as rash, itching, hives or swelling of the face inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in chest pain, breathlessness and/or palpitations	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
diarrhoea vomiting pain in arm extensive swelling of vaccinated arm swelling of face (people who have had facial dermal fillers) unusual sensation (e.g. tingling or pricking, “pins-and-needles”) numbness skin lesions (bull's-eye-shaped) dizziness genital ulcers heavy menstrual (period) bleeding headache (including migraine)	Speak to your doctor if you have any of these side effects and they worry you.

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 Original/Omicron BA.1 contains

Active ingredients (main ingredients)	Tozinameran Riltozinameran
Other ingredients (inactive ingredients)	((4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) Distearoylphosphatidylcholine (DSPC) Cholesterol Sucrose Trometamol Trometamol hydrochloride Water for injections

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

What COMIRNATY Original/Omicron BA.1 looks like

COMIRNATY Original/Omicron BA.1 is a white to off-white suspension.

COMIRNATY Original/Omicron BA.1 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 394890.

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