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.4-5?
COMIRNATY Original/Omicron BA.4-5 is a vaccine given to prevent coronavirus disease
2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 6 months of age and older. COMIRNATY Original/Omicron BA.4-5 contains
the active ingredients tozinameran and famtozinameran. For more information, see Section
1. Why am I being given COMIRNATY Original/Omicron BA.4-5? in the full CMI.
2. What should I know before I am given COMIRNATY Original/Omicron BA.4-5?
You should not be given COMIRNATY Original/Omicron BA.4-5 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 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. This vaccine should not be given to children
under 5 years. For more information, see Section
2. What should I know before I am given COMIRNATY Original/Omicron BA.4-5? 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 Original/Omicron BA.4-5?
COMIRNATY Original/Omicron BA.4-5 will be given as an injection into the muscle of
your upper arm 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 Original/Omicron BA.4-5? in the full CMI.
5. What should I know while being given COMIRNATY Original/Omicron BA.4-5?
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Things you should know
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If you receive one dose of COMIRNATY Original/Omicron BA.4-5, you should continue
to receive the same vaccine to complete the primary vaccination schedule.
Additional dose(s) of may be given at least 3 months after the previous dose.
You may not be protected against COVID-19 disease until at least seven days after
the last dose of your primary vaccination schedule. It is very important you complete
your primary vaccination.
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Driving or using machines
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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.
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6. Are there any side effects?
Very common side effects of COMIRNATY Original/Omicron BA.4-5 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 famtozinameran
This vaccine has provisional approval in Australia to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals
6 months 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.4-5. 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 Original/Omicron
BA.4-5.
Where to find information in this leaflet:
1. Why am I being given COMIRNATY Original/Omicron BA.4-5?
COMIRNATY Original/Omicron BA.4-5 contains the active ingredients tozinameran and
famtozinameran. COMIRNATY Original/Omicron BA.4-5 is an mRNA (messenger ribonucleic acid) vaccine.
COMIRNATY Original/Omicron BA.4-5 is a vaccine given to prevent COVID-19 disease caused
by SARS-CoV-2 virus in individuals 6 months of age and older.
COMIRNATY Original/Omicron BA.4-5 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 Original/Omicron BA.4-5?
Warnings
COMIRNATY Original/Omicron BA.4-5 should not be given:
1. if you are allergic to tozinameran, famtozinameran 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 Original/Omicron BA.4-5 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 Original/Omicron BA.4-5 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 Original/Omicron BA.4-5 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
Original/Omicron BA.4-5.
4. How will I be given COMIRNATY Original/Omicron BA.4-5?
COMIRNATY Original/Omicron BA.4-5 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.
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.
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.
Additional dose(s) of may be given at least 3 months after the primary vaccination
or previous dose.
A doctor, nurse or pharmacist will observe you for at least 15 minutes after being
given the vaccine.
5. What should I know while being given COMIRNATY Original/Omicron BA.4-5?
Things you should know
If you receive one dose of COMIRNATY Original/Omicron BA.4-5, 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 the vaccine at least
28 days after the second dose as part of the primary vaccination.
Additional dose(s) of the vaccine may be given at least 3 months after the previous
dose.
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 or use any machines or tools until you know how COMIRNATY
Original/Omicron BA.4-5 affects you.
Some of the side effects of COMIRNATY Original/Omicron BA.4-5 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
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Very common side effects
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What to do
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pain/swelling/tenderness at injection site
tiredness
headache
muscle pain
chills
joint pain
fever
irritability (in 6 months to less than 2 years of age)
decreased appetite (in 6 months to less than 2 years of age)
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Speak to your doctor if you have any of these very common side effects and they worry
you.
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Common side effects
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Common side effects
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What to do
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redness at injection site
nausea
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Speak to your doctor if you have any of these common side effects and they worry you.
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Uncommon side effects
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Uncommon side effects
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What to do
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enlarged lymph nodes
feeling unwell
arm pain
insomnia
decreased appetite
excessive sweating
night sweats
physical weakness and/or lack of energy
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Speak to your doctor if you have any of these side effects and they worry you.
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Rare side effects
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Rare side effects
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What to do
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temporary one-sided facial drooping
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice this side effect.
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Other side effects (frequency unknown)
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Other side effects (frequency unknown)
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What to do
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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
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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.
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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 ulcer
heavy menstrual (period) bleeding
headache (including migraine)
breast pain, swelling, warmth and redness
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Speak to your doctor if you have any of these side effects and they worry you.
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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.4-5 contains
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Active ingredients
(main ingredients)
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Tozinameran
Famtozinameran
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Other ingredients
(inactive ingredients)
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((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
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Do not receive this vaccine if you are allergic to any of these ingredients.
What COMIRNATY Original/Omicron BA.4-5 looks like
COMIRNATY Original/Omicron BA.4-5 (Grey, Orange and Maroon cap) is a white to off-white
frozen suspension.
COMIRNATY Original/Omicron BA.4-5 (Blue cap) is a clear to slightly opalescent solution.
Maroon cap vial (For Age 6 months to less than 5 Years):
COMIRNATY Original/Omicron BA.4-5 (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 417266
Blue cap vial (For Age 5 to less than 12 Years):
COMIRNATY Original/Omicron BA.4-5 (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 413720
Each multidose vial (Dark Blue) contains 6 doses of vaccine (2.25 mL fill). AUST R
413719
Orange cap vial (For Age 5 to less than 12 Years):
COMIRNATY Original/Omicron BA.4-5 (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 412350
Grey cap vial (For Ages 12 Years and older):
COMIRNATY Original/Omicron BA.4-5 (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 413718
Each multidose vial (Dark Grey) contains 6 doses of vaccine (2.25 mL fill). AUST R
400874
Not all presentations may be available.
Who distributes COMIRNATY Original/Omicron BA.4-5
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
COMIRNATY® is a registered trademark of BioNTech SE. Used under license.
This leaflet was prepared in June 2024.
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