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?
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?
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Things you should know
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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.
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 dose of COMIRNATY may be given at least 4 months after a previous
booster.
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 COMIRNATY
affects you. Some of the side effects of COMIRNATY 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 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 ingredient:
tozinameran
Full 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
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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)
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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 (very common in 6 months to less than 2 years of age)
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 ulcers
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 contains
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Active ingredient
(main ingredient)
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tozinameran
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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 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
COMIRNATY® is a registered trademark of BioNTech SE. Used under license.
This leaflet was prepared in June 2024.
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