WHO PACKAGE LEAFLET99

Package leaflet: Information for the user
Comirnaty 10 micrograms/dose concentrate for dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine (nucleoside modified)tozinameranThis medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects your child may get. See the end ofsection 4 for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or nurse.
x
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes anypossible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty is and what it is used for
2. What you need to know before your child receives Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information
1.

What Comirnaty is and what it is used for

Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty 10 micrograms/dose concentrate for dispersion for injection is given to children from 5 to
11 years of age.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood
cells that work against the virus, so giving protection against COVID-19.
As Comirnaty does not contain the virus to produce immunity, it cannot give your child COVID-19.
2.

What you need to know before your child receives Comirnaty

Comirnaty should not be givenx
if your child is allergic to the active substance or any of the other ingredients of this medicine(listed in section 6)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before your child is given the vaccine if your child:x
has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given Comirnaty in the past.
x
is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
xhas a severe illness or infection with high fever. However, your child can have the vaccination if
he/she have a mild fever or upper airway infection like a cold.

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xx

has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots.
has a weakened immune system, because of a disease such as HIV infection or a medicine suchas corticosteroid that affects the immune system.

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis(inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). Theseconditions can develop within just a few days after vaccination and have primarily occurred within
14 days. They have been observed more often after the second vaccination, and more often in younger
males. 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.
As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known howlong you will be protected.
Your child may receive a third dose of Comirnaty. The efficacy of Comirnaty, even after a third dose,
may be lower in people who are immunocompromised. In these cases, you should continue tomaintain physical precautions to help prevent COVID-19. In addition, your close contacts should bevaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
ChildrenComirnaty is not recommended for children aged under 5 years.
Other medicines and Comirnaty
Tell your doctor or pharmacist if your child is using, has recently used or might use any othermedicines or has recently received any other vaccine.
Pregnancy and breast-feeding
If your child is pregnant, tell your doctor, nurse or pharmacist before your child receives this vaccine.
Comirnaty can be used during pregnancy. A large amount of information from pregnant women
vaccinated with Comirnaty during the second and third trimester have not shown negative effects on
the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby
after vaccination during the first trimester is limited, no change to the risk for miscarriage has been
seen.
Comirnaty can be given during breast-feeding.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect your ability to use machines or undertake activities such as cycling. Wait until these effects haveworn off before resuming activities that require your full attention.
3.

How Comirnaty is given

Comirnaty is given after dilution as an injection of 0.2 mL into a muscle of the upper arm.
Your child will receive 2 injections.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose tocomplete the vaccination course.
If your child is immunocompromised, he or she may receive a third dose of Comirnaty at least 28 days
after the second dose.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.

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4.

Possible side effects

Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 peoplex
injection site: pain, swelling, rednessxtirednessxheadachex
muscle painxchillsx
joint painx
diarrhoeaxfever
Common side effects: may affect up to 1 in 10 peoplexnauseax
vomiting
Uncommon side effects: may affect up to 1 in 100 peoplexenlarged lymph nodes (more frequently observed after the booster dose)x
feeling unwellx
arm painx
insomniax
injection site itchingx
allergic reactions such as rash or itchingx
feeling weak or lack of energy/sleepyxdecreased appetitex
excessive sweatingxnight sweats
Rare side effects: may affect up to 1 in 1,000 peoplex
temporary one sided facial droopingx
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 peoplex
inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart(pericarditis) which can result in breathlessness, palpitations or chest pain
Not known (cannot be estimated from the available data)x
severe allergic reactionx
extensive swelling of the vaccinated limb
xswelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)xa skin reaction that causes red spots or patches on the skin, that may look like a target or“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)x
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)xdecreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the national reporting
system and include batch/Lot number if available. By reporting side effects you can help provide more
information on the safety of this medicine.

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5.

How to store Comirnaty

The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should befollowed.
Keep this medicine out of the sight and reach of children.
The following information about storage, expiry and use and handling is intended for healthcare
professionals.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The
expiry date refers to the last day of that month.
Store in freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
The vaccine will be received frozen at -90 °C to -60 °C. Frozen vaccine can be stored either at -90 °C
to -60 °C or 2 °C to 8 °C upon receipt.
When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for
4 hours. Once removed from the freezer, the unopened vial may be stored and transported refrigerated
at 2 °C to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton
should be marked with the new discard date at 2 °C to 8 °C. Once thawed, the vaccine cannot be refrozen.
Thawed vials can be handled in room light conditions.
Once the vaccine vial is diluted, it should be used immediately or within 6 hours and kept at 2 °C to8 °C. Discard any unused vaccine.
Do not use this vaccine if you notice particulates in the dilution or discolouration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how tothrow away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Comirnaty containsx
The active substance is COVID-19 mRNA Vaccine called tozinameran. After dilution, the vialcontains 10 doses of 0.2 mL with 10 micrograms tozinameran each.
xThe other ingredients are: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) cholesterol
 trometamol
 trometamol hydrochloride
 sucrose water for injections

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What Comirnaty looks like and contents of the packThe vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 10 doses
in a 2 mL clear vial (type I glass), with a rubber stopper and an orange flip-off plastic cap withaluminium seal.
Pack sizes: 195 vials or 10 vials
Not all pack sizes may be marketed.
Manufacturer
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.deThis leaflet was last revised in {MM/YYYY}
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly after dilution as a course of 2 doses (0.2 mL each) 3 weeks
apart.
A third dose may be given at least 28 days after the second dose to individuals who are severely
immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch numberof the administered product should be clearly recorded.
Handling instructions
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should befollowed.
Comirnaty 10 micrograms/dose should be prepared by a healthcare professional using aseptic
technique to ensure the sterility of the prepared dispersion.

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VIAL VERIFICATION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE
FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)x Verify that the vial has an orange plasticcap.
x If the vial has a purple plastic cap, please
Orange cap
make reference to the WHO Product
Information for Comirnaty
30 micrograms/dose concentrate fordispersion for injection.
x If the vial has a grey plastic cap, please
10 mcgmake reference to the WHO Product
Information for Comirnaty
30 micrograms/dose dispersion forinjection.
HANDLING PRIOR TO USE OF COMIRNATY 10 MICROGRAMS/DOSE
CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
x If the multidose vial is stored frozen it
must be thawed prior to use. Frozen vials
should be transferred to an environmentof 2 °C to 8 °C to thaw; a 10 vial packmay take 4 hours to thaw. Ensure vials
are completely thawed prior to use.
xUpon moving vials to 2 °C to 8 °C
Store for up tostorage, update the expiry date on the10 weeks at 2 °Ccarton.
to 8 °C
x Unopened vials can be stored for up to10 weeks at 2 °C to 8 °C; not exceeding
the printed expiry date (EXP).
x Thawed vials can be handled in room
light conditions.
MIXING PRIOR TO DILUTION OF COMIRNATY 10 MICROGRAMS/DOSE
CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)
x Allow the thawed vial to come to room
temperature and gently invert it 10 times
prior to dilution. Do not shake.
x Prior to dilution, the thawed dispersion
may contain white to off-white opaqueamorphous particles.

Gently × 10123

DILUTION OF COMIRNATY10 MICROGRAMS/DOSE CONCENTRATE FORDISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)x The thawed vaccine must be diluted in its
original vial with 1.3 mL sodiumchloride 9 mg/mL (0.9%) solution for
injection, using a 21 gauge or narrower
needle and aseptic techniques.

1.3 mL of 0.9% sodium chloride injectionx

Pull back plunger to 1.3 mL toremove air from vial.

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Equalise vial pressure before removing
the needle from the vial stopper bywithdrawing 1.3 mL air into the empty
diluent syringe.

xxGently invert the diluted dispersion
10 times. Do not shake.
The diluted vaccine should present as awhite to off-white dispersion with noparticulates visible. Do not use thediluted vaccine if particulates ordiscolouration are present.

Gently × 10xxx

Record appropriate date and time.
Use within 6 hours after dilution.

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The diluted vials should be marked withthe appropriate date and time.
After dilution, store at 2 ºC to 8 ºC and
use within 6 hours.
Do not freeze or shake the diluteddispersion. If refrigerated, allow thediluted dispersion to come to room
temperature prior to use.

PREPARATION OF INDIVIDUAL 0.2 mL DOSES OF COMIRNATY
10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION(CHILDREN 5 TO 11 YEARS)
x After dilution, the vial contains 2.6 mLfrom which 10 doses of 0.2 mL can beextracted.
x Using aseptic technique, cleanse the vial
stopper with a single use antiseptic swab.
x Withdraw 0.2 mL of Comirnaty forchildren age 5 to 11 years.
Low dead-volume syringes and/orneedles should be used in order to extract
10 doses from a single vial. The low
dead-volume syringe and needle
combination should have a dead volumeof no more than 35 microlitres.

0.2 mL diluted vaccinexxx

If standard syringes and needles are used,
there may not be sufficient volume to
extract ten doses from a single vial.
Each dose must contain 0.2 mL ofvaccine.
If the amount of vaccine remaining in thevial cannot provide a full dose of 0.2 mL,
discard the vial and any excess volume.
Discard any unused vaccine within
6 hours after dilution.

Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

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