Consumer Medicine Information (CMI) summary
speak to your doctor or pharmacist.
full CMI for further details.
Table of Contents
Why am I being given COMIRNATY Original/Omicron BA.4-5?
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 12 years 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.
What should I know before I am given COMIRNATY Original/Omicron BA.4-5?
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.4-5 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 children under 12 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.
What if I am taking other medicines?
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.
How will I be given COMIRNATY Original/Omicron BA.4-5?
your upper arm by a doctor, nurse or pharmacist. You will be given one dose at least
3 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.4-5 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.4-5? in the full CMI.
What should I know while being given COMIRNATY Original/Omicron BA.4-5?
|
Things you should know |
An initial dose of COMIRNATY Original/Omicron BA.4-5 may be given as a booster at COMIRNATY Original/Omicron BA.4-5 may also be given to individuals 12 years of age |
|---|---|
|
Driving or using machines |
Be careful before you drive or use any machines or tools until you know how the vaccine |
Are there any side effects?
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.
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 as a booster dose to prevent COVID-19 disease caused by SARS-CoV-2 virus
in individuals 12 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.
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:
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 as a booster dose to prevent
COVID-19 disease caused by SARS-CoV-2 virus in individuals 12 years of age and older.
COMIRNATY Original/Omicron BA.4-5 is only given as booster doses. For primary vaccination,
ask your doctor or pharmacist.
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.
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 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.
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.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 children under 12 years.
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.
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.
An initial dose of COMIRNATY Original/Omicron BA.4-5 may be given as a booster at
least 3 months after the primary vaccination for people 12 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.4-5.
COMIRNATY Original/Omicron BA.4-5 is only given as booster doses. For primary vaccination,
ask your doctor or pharmacist.
What should I know while being given COMIRNATY Original/Omicron BA.4-5?
Things you should know
An initial dose of COMIRNATY Original/Omicron BA.4-5 may be given as a booster at
least 3 months after the primary vaccination for people 12 years of age and older.
COMIRNATY Original/Omicron BA.4-5 may also be given to individuals 12 years of age
and older at least 3 months after a previous booster dose of any 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.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.
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.
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
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.
Product details
What COMIRNATY Original/Omicron BA.4-5 contains
|
Active ingredients (main ingredients) |
Tozinameran Famtozinameran |
|---|---|
|
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.4-5 looks like
COMIRNATY Original/Omicron BA.4-5 is a white to off-white suspension.
COMIRNATY Original/Omicron BA.4-5 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 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 January 2023.
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