COMIRNATY™ COVID-19 VACCINE AGE 5 TO 11
YEARSConsumer 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 orpharmacist.

1. Why am I being given COMIRNATY?
COMIRNATY (orange cap, must dilute) is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) in children from 5 to 11 years of age. 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 have had an allergic reaction to any of the ingredients in COMIRNATY. See list at theend 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 may not fully protect all those who receive it and it is not known how long you will beprotected.
Talk to your doctor if you have any other medical conditions or take any other medicines.
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. You will be given
one dose followed by a second dose at least 21 days later. It is very important that you receive your second dose. A doctor, nurse
or pharmacist will observe you for at least 15 minutes after being given COMIRNATY. 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?
Things youshould know

•If you receive one dose of COMIRNATY, you should receive a second dose of the same vaccine 21days later to complete the primary vaccination schedule.

••

You may not be protected against COVID-19 disease until at least seven days after your second dose.
You may not be protected if you only receive one dose, so a second dose is important.

•For more information, see Section 5. What should I know while being given COMIRNATY? 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.

COMIRNATY™

1COMIRNATY™ COVID-19 VACCINE AGE 5 TO 11
YEARSActive ingredient: tozinameran

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.
2.
3.
4.
5.
6.
7.

Why am I being given COMIRNATY?
What should I know before I am given COMIRNATY?
What if I am taking other medicines?
How will I be given COMIRNATY?
What should I know while being given COMIRNATY?
Are there any side effects?
Product details

1. Why am I being given COMIRNATY?
COMIRNATY (orange cap, must dilute) 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 children from 5 to
11 years of age. COMIRNATY works by triggering yourimmune system to produce antibodies and blood cells thatwork against the virus, to protect against COVID-19
disease.
COMIRNATY (orange cap, must dilute) is a new
formulation 10 microgram/0.2 mL dose, concentrate forsuspension for injection, for children 5 to 11 years of age.

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 theingredients 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 yourimmune system.

COMIRNATY™

•

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 andhow to monitor for them. See additional information
under Section 6. Are there any side effects?
Very rare cases of myocarditis (inflammation of the heartmuscle) 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 thesecond vaccination, and more often occurred in younger
men. Following vaccination, you should be alert to signs ofmyocarditis 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.
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.

Children and adolescents
COMIRNATY can be given to children age 5 to 11 years old.
COMIRNATY should not be given to children under 5 years.

3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking, haverecently 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 aretaking and if these affect, or are affected by,
COMIRNATY.

4. How will I be given COMIRNATY?
•••

COMIRNATY will be given as an injection into themuscle 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 foradvice.
A doctor, nurse or pharmacist will observe you for atleast 15 minutes after being given COMIRNATY.

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5. What should I know while being given
COMIRNATY?

Uncommon side effects

Things you should know••••••••

If you receive one dose of COMIRNATY, you should
receive a second dose of the same vaccine at least 21
days later to complete the primary vaccination
schedule.

•••

You may not be protected against COVID-19 disease
until at least seven days after your second dose.
You may not be protected if you only receive one
dose, so a second dose is important.

•Driving or using machines
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.

Storage of the vaccine
COMIRNATY is stored at -90 °C to -60 °C. It must be kept in
the original package in order to protect from light.
A doctor, nurse or pharmacist will prepare the injection foryou before you are given it.

Getting rid of any unwanted vaccine

Uncommon side effects
enlarged lymph nodes
feeling unwell
nauseadecreased appetite
hives
itchy skinrashpain in arm

What to do
Speak to yourdoctor if you
have any ofthese side
effects andthey worry you.

Other side effects (frequency unknown)
Other side effects (frequencyunknown)•••severe allergic reaction
allergic reactions such as rash,itching, hives or swelling of theface
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

What to doCall your doctor
straight away,or go straightto theEmergency
Department at
your nearest
hospital if you
notice thisserious side
effect.

A doctor, nurse or pharmacist will dispose of any unused
vaccine.

Tell your doctor or pharmacist if you notice anything elsethat may be making you feel unwell.

6. Are there any side effects?

Other side effects not listed here may occur in somepeople.

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 yourdoctor or pharmacist if you have any further questions
about side effects.

Very common side effects
Very common side effects•••••

pain/swelling/redness atinjection sitetiredness
headachemuscle painchills

What to doSpeak to yourdoctor if you
have any ofthese very
common sideeffects andthey worry you.

Common side effects
Common side effects••••

diarrhoea
vomiting
joint pain
fever

COMIRNATY™

What to do
Speak to yourdoctor if you
have any ofthese commonside effects andthey worry you.

7. Product details
What COMIRNATY contains
Activeingredient•tozinameran•((4-hydroxybutyl)azanediyl)bis(hexane6,1-diyl)bis(2-hexyldecanoate) (ALC0315)
2-[(polyethylene glycol)-2000]-N,Nditetradecylacetamide (ALC-0159)
Distearoylphosphatidylcholine (DSPC)
Cholesterol
SucroseTrometamol
Trometamol hydrochloride
Water for injections(mainingredient)
Otheringredients(inactiveingredients)•••••••Do not receive this vaccine if you are allergic to any ofthese ingredients.

What COMIRNATY looks like
COMIRNATY is a white to off-white suspension.
Orange cap vial (For Age 5 to 11 Years):

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COMIRNATY For Age 5 to 11 Years is provided in packs of
10 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). Not all presentations may
be available.

Who distributes COMIRNATY
Pfizer New Zealand Limited
PO Box 3998
AucklandToll Free Number: 0800 736 363
This leaflet was prepared in December 2021.
© Copyright

COMIRNATY™

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