Package leaflet: Information for the user
Comirnaty JN.1 10 micrograms/dose dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine
bretovameranThis 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 your child receives this vaccine because it contains
important information for your child.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your child’s doctor, pharmacist or nurse.
•
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty JN.1 is and what it is used for
2. What you need to know before your child receives Comirnaty JN.1
3. How Comirnaty JN.1 is given
4. Possible side effects
5. How to store Comirnaty JN.1
6. Contents of the pack and other information
1.

What Comirnaty JN.1 is and what it is used for

Comirnaty JN.1 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty JN.1 10 micrograms/dose dispersion for injection is given to children from 5 to 11 years ofage.
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 JN.1 does not contain the virus to produce immunity, it cannot give your child COVID19.
The use of this vaccine should be in accordance with official recommendations.
2.

What you need to know before your child receives Comirnaty JN.1

Comirnaty JN.1 should not be given•
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 child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:•has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given this vaccine in the past.
•is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
•
has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she has a mild fever or upper airway infection like a cold.
1

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••

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). These
conditions 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years comparedwith ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required
intensive care support and fatal cases have been seen. Following vaccination, you should be alert tosigns of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek
immediate medical attention should these occur.
As with any vaccine, Comirnaty JN.1 may not fully protect all those who receive it and it is not known
how long your child will be protected.
The efficacy of Comirnaty JN.1 may be lower in people who are immunocompromised. If your childis immunocompromised, he/she may receive additional doses of Comirnaty JN.1. In these cases, yourchild should continue to maintain physical precautions to help prevent COVID-19. In addition, yourchild’s close contacts should be vaccinated as appropriate. Discuss appropriate individual
recommendations with your child’s doctor.
ChildrenComirnaty JN.1 10 micrograms/dose dispersion for injection is not recommended for children aged
under 5 years.
There are paediatric formulations available for infants and children aged 6 months to 4 years. For
details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty JN.1
Tell your child’s 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 child’s doctor, nurse or pharmacist before your child receives this
vaccine.
No data are available yet regarding the use of Comirnaty JN.1 during pregnancy. However, a large
amount of information from pregnant women vaccinated with the initially approved Comirnaty
vaccine 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
JN.1 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding. However, noeffects on the breastfed newborn/infant are anticipated. Data from women who were breast-feeding
after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse
effects in breastfed newborns/infants. Comirnaty JN.1 can be used while breast-feeding.

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Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect your child’s ability to use machines or undertake activities such as cycling. Wait until theseeffects have worn off before resuming activities that require your child’s full attention.
3.

How Comirnaty JN.1 is given

Comirnaty JN.1 is given as an injection of 0.3 mL into a muscle of your child’s upper arm.
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine
before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of
Comirnaty JN.1 until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty JN.1.
If you have any further questions on the use of Comirnaty JN.1, ask your child’s doctor, pharmacist or
nurse.
4.

Possible side effects

Like all vaccines, Comirnaty JN.1 can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people•
injection site: pain, swelling•
tiredness, headache•
muscle pain, joint pain•
chills, fever•
diarrhoea
Common side effects: may affect up to 1 in 10 people•
nausea, vomiting•
injection site redness (‘very common’ in 5 to 11 years of age)•enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people•
feeling unwell, feeling weak or lack of energy/sleepy•
arm pain•insomnia•
injection site itching•allergic reactions such as rash or itching•
decreased appetite•dizziness•
excessive sweating, night sweats
Rare side effects: may affect up to 1 in 1 000 people•
temporary one sided facial drooping•
allergic reactions such as hives or swelling of the face3

Pfleet no: 2024-0092071

Very rare side effects: may affect up to 1 in 10 000 people•
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)•
severe allergic reaction•
extensive swelling of the vaccinated limb•
swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)•a 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)•
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)•
decreased feeling or sensitivity, especially in the skin (hypoaesthesia)•
heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
Ireland
You can also report side effects directly via HPRA Pharmacovigilance.
Website: www.hpra.ie
United Kingdom (Northern Ireland)
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card
reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Comirnaty JN.1

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.
Single dose vials: When stored frozen at -90 °C to -60 °C, 10-vial packs of single dose vials of thevaccine can be thawed at 2 °C to 8 °C for 2 hours or individual vials can be thawed at room
temperature (up to 30 °C) for 30 minutes.

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Multidose vials: 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 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for
30 minutes.
Thawed (previously frozen) vials: 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 expiry date at 2 °C to 8 °C. Once thawed, thevaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and
30 °C.
Thawed vials can be handled in room light conditions.
Opened vials: After first puncture, store the vaccine at 2 °C to 30 °C and use within 12 hours, which
includes up to 6 hours transportation time. Discard any unused vaccine.
Do not use this vaccine if you notice particulates 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 JN.1 contains•
The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is calledbretovameran.
− A single dose vial contains 1 dose of 0.3 mL with 10 micrograms of bretovameran per
dose.
− A multidose vial contains 6 doses of 0.3 mL with 10 micrograms of bretovameran per
dose.
•
The 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
What Comirnaty JN.1 looks like and contents of the packThe vaccine is a clear to slightly opalescent dispersion (pH: 6.9 - 7.9) provided in either:•
A single dose vial of 1 dose in a 2 mL clear vial (type I glass), with a rubber stopper and a blue
flip-off plastic cap with aluminium seal; or•A multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a blue
flip-off plastic cap with aluminium seal.
Single dose vials pack size: 10 vials
Multidose vials pack size: 10 vials
Not all pack sizes may be marketed.
5

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Marketing Authorisation Holder
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
IrelandPfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)+44 (0)1304 616161
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This leaflet was last revised in 07/2024.
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.
Ref: bCY (JN.1) 10 mcg RTU 1_0-----------------------------------------------------------------------------------------------------------------------6

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The following information is intended for healthcare professionals only:
Administer Comirnaty JN.1 intramuscularly as a single dose of 0.3 mL regardless of prior COVID-19
vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty JN.1
should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be given 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 prior to use
Comirnaty JN.1 should be prepared by a healthcare professional using aseptic technique to ensure thesterility of the prepared dispersion.
•
Verify that the vial has a blue plastic cap and the product name is Comirnaty JN.1
10 micrograms/dose dispersion for injection (children 5 to 11 years).
•
If the vial has another product name on the label, please make reference to the Summary of
Product Characteristics for that formulation.
•
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred toan environment of 2 °C to 8 °C to thaw. Ensure vials are completely thawed prior to use.
−
Single dose vials: A 10-vial pack of single dose vials may take 2 hours to thaw.
−
Multidose vials: A 10-vial pack of multidose vials may take 6 hours to thaw.
•
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
•
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed
expiry date (EXP).
•
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
•
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.
Preparation of 0.3 mL doses•
Gently mix by inverting vials 10 times prior to use. Do not shake.
•
Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous
particles.
•
After mixing, the vaccine should present as a clear to slightly opalescent dispersion with noparticulates visible. Do not use the vaccine if particulates or discolouration are present.
•
Check whether the vial is a single dose vial or a multidose vial and follow the applicablehandling instructions below:− Single dose vials
 Withdraw a single 0.3 mL dose of vaccine.
 Discard vial and any excess volume.
− Multidose vials
 Multidose vials contain 6 doses of 0.3 mL each.
 Using aseptic technique, cleanse the vial stopper with a single-use antisepticswab.
 Withdraw 0.3 mL of Comirnaty JN.1 for children aged 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from asingle vial. The low dead-volume syringe and needle combination should have a dead volume ofno more than 35 microlitres. If standard syringes and needles are used, there may not be
sufficient volume to extract a sixth dose from a single vial.
•
Each dose must contain 0.3 mL of vaccine.
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••

If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard thevial and any excess volume.
Record the appropriate date/time on the vial. Discard any unused vaccine 12 hours after firstpuncture.

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

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Package leaflet: Information for the user
Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine
raxtozinameranThis 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 your child receives this vaccine because it contains
important information for your child.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your child’s doctor, pharmacist or nurse.
•
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is given
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information
1.

What Comirnaty Omicron XBB.1.5 is and what it is used for

Comirnaty Omicron XBB.1.5 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 10 micrograms/dose 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 Omicron XBB.1.5 does not contain the virus to produce immunity, it cannot give yourchild COVID-19.
The use of this vaccine should be in accordance with official recommendations.
2.

What you need to know before your child receives Comirnaty Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 should not be given•
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 child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:•has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given this vaccine in the past.
•is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
•
has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she has a mild fever or upper airway infection like a cold.
1

Pfleet no: 2023-0088411

••

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). These
conditions 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years comparedwith ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required
intensive care support and fatal cases have been seen. Following vaccination, you should be alert tosigns of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek
immediate medical attention should these occur.
As with any vaccine, Comirnaty Omicron XBB.1.5 may not fully protect all those who receive it and it
is not known how long your child will be protected.
The efficacy of Comirnaty Omicron XBB.1.5 may be lower in people who are immunocompromised.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron
XBB.1.5. In these cases, your child should continue to maintain physical precautions to help prevent
COVID-19. In addition, your child’s close contacts should be vaccinated as appropriate. Discussappropriate individual recommendations with your child’s doctor.
ChildrenComirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection is not recommended forchildren aged under 5 years.
There are paediatric formulations available for infants and children aged 6 months to 4 years. For
details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty Omicron XBB.1.5
Tell your child’s 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 child’s doctor, nurse or pharmacist before your child receives this
vaccine.
No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during pregnancy.
However, a large amount of information from pregnant women vaccinated with the initially approved
Comirnaty vaccine 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 Omicron XBB.1.5 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during breast-feeding.
However, no effects on the breastfed newborn/infant are anticipated. Data from women who werebreast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk
for adverse effects in breastfed newborns/infants. Comirnaty Omicron XBB.1.5 can be usedwhile breast-feeding.

2

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Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect your child’s ability to use machines or undertake activities such as cycling. Wait until theseeffects have worn off before resuming activities that require your child’s full attention.
3.

How Comirnaty Omicron XBB.1.5 is given

Comirnaty Omicron XBB.1.5 is given as an injection of 0.3 mL into a muscle of your child’s upperarm.
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine
before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of
Comirnaty Omicron XBB.1.5 until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron
XBB.1.5.
If you have any further questions on the use of Comirnaty Omicron XBB.1.5, ask your child’s doctor,
pharmacist or nurse.
4.

Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 can cause side effects, although not everybody getsthem.
Very common side effects: may affect more than 1 in 10 people•
injection site: pain, swelling•
tiredness, headache•
muscle pain, joint pain•
chills, fever•
diarrhoea
Common side effects: may affect up to 1 in 10 people•
nausea, vomiting•
injection site redness (‘very common’ in 5 to 11 years of age)•enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people•
feeling unwell, feeling weak or lack of energy/sleepy•
arm pain•insomnia•
injection site itching•allergic reactions such as rash or itching•
decreased appetite•dizziness•
excessive sweating, night sweats
Rare side effects: may affect up to 1 in 1 000 people•
temporary one sided facial drooping
3

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•allergic reactions such as hives or swelling of the face

Very rare side effects: may affect up to 1 in 10 000 people•
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)•
severe allergic reaction•
extensive swelling of the vaccinated limb•
swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)•a 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)•
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)•
decreased feeling or sensitivity, especially in the skin (hypoaesthesia)•
heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)
Reporting of side effects
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
Ireland
You can also report side effects directly via HPRA Pharmacovigilance.
Website: www.hpra.ie
United Kingdom (Northern Ireland)
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card
reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Comirnaty Omicron XBB.1.5

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.
Single dose vials: When stored frozen at -90 °C to -60 °C, 10-vial packs of single dose vials of thevaccine can be thawed at 2 °C to 8 °C for 2 hours or individual vials can be thawed at room
temperature (up to 30 °C) for 30 minutes.

4

Pfleet no: 2023-0088411

Multidose vials: 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 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for
30 minutes.
Thawed (previously frozen) vials: 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 expiry date at 2 °C to 8 °C. Once thawed, thevaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and
30 °C.
Thawed vials can be handled in room light conditions.
Opened vials: After first puncture, store the vaccine at 2 °C to 30 °C and use within 12 hours, which
includes up to 6 hours transportation time. Discard any unused vaccine.
Do not use this vaccine if you notice particulates 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 Omicron XBB.1.5 contains•
The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called
raxtozinameran.
− A single dose vial contains 1 dose of 0.3 mL with 10 micrograms of raxtozinameran per
dose.
− A multidose vial contains 6 doses of 0.3 mL with 10 micrograms of raxtozinameran per
dose.
•
The 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
What Comirnaty Omicron XBB.1.5 looks like and contents of the packThe vaccine is a clear to slightly opalescent dispersion (pH: 6.9 - 7.9) provided in either:• A single dose vial of 1 dose in a 2 mL clear vial (type I glass), with a rubber stopper and ablue flip-off plastic cap with aluminium seal; or• A multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and ablue flip-off plastic cap with aluminium seal.
Single dose vials pack size: 10 vials
Multidose vials pack size: 10 vials
Not all pack sizes may be marketed.
5

Pfleet no: 2023-0088411

Marketing Authorisation Holder
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
IrelandPfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)+44 (0)1304 616161
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This leaflet was last revised in 07/2024.
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.
Ref: bCY (XBB.1.5) 10 mcg RTU 7_0-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:

6

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Administer Comirnaty Omicron XBB.1.5 intramuscularly as a single dose of 0.3 mL regardless ofprior COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty Omicron
XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be given 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 prior to use
Comirnaty Omicron XBB.1.5 should be prepared by a healthcare professional using aseptic techniqueto ensure the sterility of the prepared dispersion.
•
•
•

•
•
•
•

Verify that the vial has a blue plastic cap and the product name is Comirnaty Omicron
XBB.1.5 10 micrograms/dose dispersion for injection (children 5 to 11 years).
If the vial has another product name on the label, please make reference to the Summary of
Product Characteristics for that formulation.
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred toan environment of 2 °C to 8 °C to thaw. Ensure vials are completely thawed prior to use.
−
Single dose vials: A 10-vial pack of single dose vials may take 2 hours to thaw.
−
Multidose vials: A 10-vial pack of multidose vials may take 6 hours to thaw.
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed
expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.

Preparation of 0.3 mL doses•
Gently mix by inverting vials 10 times prior to use. Do not shake.
•
Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous
particles.
•
After mixing, the vaccine should present as a clear to slightly opalescent dispersion with noparticulates visible. Do not use the vaccine if particulates or discolouration are present.
•
Check whether the vial is a single dose vial or a multidose vial and follow the applicablehandling instructions below:− Single dose vials
 Withdraw a single 0.3 mL dose of vaccine.
 Discard vial and any excess volume.
− Multidose vials
 Multidose vials contain 6 doses of 0.3 mL each.
 Using aseptic technique, cleanse the vial stopper with a single-use antisepticswab.
 Withdraw 0.3 mL of Comirnaty Omicron XBB.1.5 for children aged 5 to 11
years.
Low dead-volume syringes and/or needles should be used in order to extract 6 doses from asingle vial. The low dead-volume syringe and needle combination should have a dead volume ofno more than 35 microlitres. If standard syringes and needles are used, there may not be
sufficient volume to extract a sixth dose from a single vial.
7
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•••Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard thevial and any excess volume.
Record the appropriate date/time on the vial. Discard any unused vaccine 12 hours after firstpuncture.

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

8

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Package leaflet: Information for the user
Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine
raxtozinameranThis 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 your child receives this vaccine because it contains
important information for your child.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your child’s doctor, pharmacist or nurse.
•
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is given
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information
1.

What Comirnaty Omicron XBB.1.5 is and what it is used for

Comirnaty Omicron XBB.1.5 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection is given tochildren 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 Omicron XBB.1.5 does not contain the virus to produce immunity, it cannot give yourchild COVID-19.
The use of this vaccine should be in accordance with official recommendations.
2.

What you need to know before your child receives Comirnaty Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 should not be given•
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 child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:•has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given this vaccine in the past.
•is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
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•••

has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she has a mild fever or upper airway infection like a cold.
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). These
conditions 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years comparedwith ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required
intensive care support and fatal cases have been seen. Following vaccination, you should be alert tosigns of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek
immediate medical attention should these occur.
As with any vaccine, Comirnaty Omicron XBB.1.5 may not fully protect all those who receive it and it
is not known how long your child will be protected.
The efficacy of Comirnaty Omicron XBB.1.5 may be lower in people who are immunocompromised.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron
XBB.1.5. In these cases, your child should continue to maintain physical precautions to help prevent
COVID-19. In addition, your child’s close contacts should be vaccinated as appropriate. Discussappropriate individual recommendations with your child’s doctor.
ChildrenComirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection is notrecommended for children aged under 5 years.
There are paediatric formulations available for infants and children aged 6 months to 4 years. For
details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty Omicron XBB.1.5
Tell your child’s 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 child’s doctor, nurse or pharmacist before your child receives this
vaccine.
No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during pregnancy.
However, a large amount of information from pregnant women vaccinated with the initially approved
Comirnaty vaccine 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 Omicron XBB.1.5 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during breast-feeding.
However, no effects on the breastfed newborn/infant are anticipated. Data from women who werebreast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk
for adverse effects in breastfed newborns/infants. Comirnaty Omicron XBB.1.5 can be used whilebreast-feeding.
2

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Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect your child’s ability to use machines or undertake activities such as cycling. Wait until theseeffects have worn off before resuming activities that require your child’s full attention.
3.

How Comirnaty Omicron XBB.1.5 is given

Comirnaty Omicron XBB.1.5 is given after dilution as an injection of 0.2 mL into a muscle of yourchild’s upper arm.
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine
before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of
Comirnaty Omicron XBB.1.5 until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron
XBB.1.5.
If you have any further questions on the use of Comirnaty Omicron XBB.1.5, ask your child’s doctor,
pharmacist or nurse.
4.

Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 can cause side effects, although not everybody getsthem.
Very common side effects: may affect more than 1 in 10 people•
injection site: pain, swelling•
tiredness, headache•
muscle pain, joint pain•
chills, fever•
diarrhoea
Common side effects: may affect up to 1 in 10 people•
nausea, vomiting•
injection site redness (‘very common’ in 5 to 11 years of age)•enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people•
feeling unwell, feeling weak or lack of energy/sleepy•
arm pain•insomnia•
injection site itching•allergic reactions such as rash or itching•
decreased appetite•dizziness•
excessive sweating, night sweats

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Rare side effects: may affect up to 1 in 1 000 people•
temporary one sided facial drooping•
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10 000 people•
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)•
severe allergic reaction•
extensive swelling of the vaccinated limb•
swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)•a 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)•
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)•
decreased feeling or sensitivity, especially in the skin (hypoaesthesia)•
heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)
Reporting of side effects
If your child gets get any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
Ireland
You can also report side effects directly via HPRA Pharmacovigilance.
Website: www.hpra.ie
United Kingdom (Northern Ireland)
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card
reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Comirnaty Omicron XBB.1.5

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 or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
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Thawed (previously frozen) vials: 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 expiry date at 2 °C to 8 °C. Once thawed, thevaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and
30 °C.
Thawed vials can be handled in room light conditions.
After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes up to 6 hours
transportation time. 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 Omicron XBB.1.5 contains• The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called
raxtozinameran. After dilution, the vial contains 10 doses of 0.2 mL with 10 micrograms
raxtozinameran each.
• The 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
What Comirnaty Omicron XBB.1.5 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 size: 10 vials
Marketing Authorisation Holder
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de5

Pfleet no: 2023-0088411

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
IrelandPfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)+44 (0)1304 616161
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This leaflet was last revised in 07/2024.
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.
Ref: bCY (XBB.1.5) 10 mcg Conc 5_0-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Administer Comirnaty Omicron XBB.1.5 intramuscularly after dilution as a single dose of 0.2 mL
regardless of prior COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty Omicron
XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be given to individuals who are severely immunocompromised.

6

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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 prior to use
Comirnaty Omicron XBB.1.5 should be prepared by a healthcare professional using aseptic techniqueto ensure the sterility of the prepared dispersion.
•
•
•
•
•
•
•

Verify that the vial has an orange plastic cap and the product name is Comirnaty Omicron
XBB.1.5 10 micrograms/dose concentrate for dispersion for injection (children 5 to
11 years).
If the vial has another product name on the label, please make reference to the Summary of
Product Characteristics for that formulation.
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred toan environment of 2 °C to 8 °C to thaw; a 10-vial pack may take 4 hours to thaw. Ensure vials
are completely thawed prior to use.
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed
expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.

Dilution•
Allow the thawed vial to come to room temperature and gently invert it 10 times prior todilution. Do not shake.
•
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous
particles.
•
The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL(0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
•
Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL
air into the empty diluent syringe.
•
Gently invert the diluted dispersion 10 times. Do not shake.
•
The diluted vaccine should present as a white to off-white dispersion with no particulates
visible. Do not use the diluted vaccine if particulates or discolouration are present.
•
The diluted vials should be marked with the appropriate discard date and time.
•
After dilution, store at 2 ºC to 30 ºC and use within 12 hours.
•
Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion tocome to room temperature prior to use.
Preparation of 0.2 ml doses•
After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
•
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
•
Withdraw 0.2 mL of Comirnaty Omicron XBB.1.5 for children aged 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 10 doses from asingle vial. The low dead-volume syringe and needle combination should have a dead volume ofno more than 35 microlitres. 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 of vaccine.
7

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••If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard thevial and any excess volume.
Discard any unused vaccine within 12 hours after dilution.

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

8

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Package leaflet: Information for the user
Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for
injection
Children 5 to 11 years
COVID-19 mRNA Vaccine
tozinameran/famtozinameranThis 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 your child receives this vaccine because it contains
important information for your child.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your child’s doctor, pharmacist or nurse.
•
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Comirnaty Original/Omicron BA.4-5 is and what it is used for
2. What you need to know before your child receives Comirnaty Original/Omicron BA.4-5
3. How Comirnaty Original/Omicron BA.4-5 is given
4. Possible side effects
5. How to store Comirnaty Original/Omicron BA.4-5
6. Contents of the pack and other information
1.

What Comirnaty Original/Omicron BA.4-5 is and what it is used for

Comirnaty Original/Omicron BA.4-5 is a vaccine used for preventing COVID-19 caused by
SARS-CoV-2. It 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 Original/Omicron BA.4-5 does not contain the virus to produce immunity, it cannot
give your child COVID-19.
The use of this vaccine should be in accordance with official recommendations.
2.

What you need to know before your child receives Comirnaty Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 should not be given•
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 child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:•has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given this vaccine in the past.
•is feeling nervous about the vaccination process or has ever fainted following any needle
injection.

12023-0088411

Pfleet no:•••

has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she has a mild fever or upper airway infection like a cold.
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). These
conditions 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years comparedwith ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required
intensive care support and fatal cases have been seen. Following vaccination, you should be alert tosigns of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek
immediate medical attention should these occur.
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 your child will be protected.
The efficacy of Comirnaty Original/Omicron BA.4-5 may be lower in people who are
immunocompromised. If your child is immunocompromised, he/she may receive additional doses ofComirnaty Original/Omicron BA.4-5. In these cases, your child should continue to maintain physicalprecautions to help prevent COVID-19. In addition, your child’s close contacts should be vaccinatedas appropriate. Discuss appropriate individual recommendations with your child’s doctor.
ChildrenComirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is
not recommended for children aged under 5 years.
There are paediatric formulations available for infants and children aged 6 months to 4 years. For
details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty Original/Omicron BA.4-5
Tell your child’s 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 child’s doctor, nurse or pharmacist before your child receives this
vaccine.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.4-5 during pregnancy.
However, a large amount of information from pregnant women vaccinated with the initially approved
Comirnaty vaccine 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 Original/Omicron BA.4-5 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.4-5 during
breast-feeding. However, no effects on the breastfed newborn/infant are anticipated. Data from women
who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not22023-0088411

Pfleet no:

shown a risk for adverse effects in breastfed newborns/infants. Comirnaty Original/Omicron BA.4-5
can be used while breast-feeding.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect your child’s ability to use machines or undertake activities such as cycling. Wait until theseeffects have worn off before resuming activities that require your child’s full attention.
3.

How Comirnaty Original/Omicron BA.4-5 is given

Comirnaty Original/Omicron BA.4-5 is given after dilution as an injection of 0.2 mL into a muscle ofyour child’s upper arm.
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine
before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of
Comirnaty Original/Omicron BA.4-5 until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty
Original/Omicron BA.4-5.
If you have any further questions on the use of Comirnaty Original/Omicron BA.4-5, ask your child’s
doctor, pharmacist or nurse.
4.

Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 can cause side effects, although not everybody
gets them.
Very common side effects: may affect more than 1 in 10 people•
injection site: pain, swelling•
tiredness, headache•
muscle pain, joint pain•
chills, fever•
diarrhoea
Common side effects: may affect up to 1 in 10 people•
nausea, vomiting•
injection site redness (‘very common’ in 5 to 11 years of age)•enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people•
feeling unwell, feeling weak or lack of energy/sleepy•
arm pain•insomnia•
injection site itching•allergic reactions such as rash or itching•
decreased appetite•dizziness•
excessive sweating, night sweats
3
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Rare side effects: may affect up to 1 in 1 000 people•
temporary one sided facial drooping•
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10 000 people•
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)•
severe allergic reaction•
extensive swelling of the vaccinated limb•
swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)•a 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)•
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)•
decreased feeling or sensitivity, especially in the skin (hypoaesthesia)•
heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)

Reporting of side effects
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
Ireland
You can also report side effects directly via HPRA Pharmacovigilance.
Website: www.hpra.ie
United Kingdom (Northern Ireland)
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card
reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Comirnaty Original/Omicron BA.4-5

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.
42023-0088411

Pfleet no: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 or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed (previously frozen) vials: 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 expiry date at 2 °C to 8 °C. Once thawed, thevaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and
30 °C.
Thawed vials can be handled in room light conditions.
After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes up to 6 hours
transportation time. 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 Original/Omicron BA.4-5 contains•
The active substances of COVID-19 mRNA Vaccine (nucleoside modified) are calledtozinameran and famtozinameran. After dilution, the vial contains 10 doses of 0.2 mL with
5 micrograms of tozinameran (Original) and 5 micrograms of famtozinameran (Omicron BA.45) per dose.
•
The 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
What Comirnaty Original/Omicron BA.4-5 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: 10 vials or 195 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
52023-0088411

Pfleet no:Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de
Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
IrelandPfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)+44 (0)1304 616161
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This leaflet was last revised in 07/2024.
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.
Ref: bCY/BA.4-5 (5-5) 12_0-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Administer Comirnaty Original/Omicron BA.4-5 intramuscularly after dilution as a single dose of
0.2 mL regardless of prior COVID-19 vaccination status.
62023-0088411

Pfleet no:For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty
Original/Omicron BA.4-5 should be administered at least 3 months after the most recent dose of a
COVID-19 vaccine.
Additional doses may be given 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 prior to use
Comirnaty Original/Omicron BA.4-5 should be prepared by a healthcare professional using aseptic
technique to ensure the sterility of the prepared dispersion.
•
•
•
•
•
•
•

Verify that the vial has an orange plastic cap and the product name is Comirnaty
Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection(children 5 to 11 years).
If the vial has another product name on the label, please make reference to the Summary of
Product Characteristics for that formulation.
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred toan environment of 2 °C to 8 °C to thaw; a 10-vial pack may take 4 hours to thaw. Ensure vials
are completely thawed prior to use.
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed
expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.

Dilution•
Allow the thawed vial to come to room temperature and gently invert it 10 times prior todilution. Do not shake.
•
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous
particles.
•
The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL(0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
•
Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL
air into the empty diluent syringe.
•
Gently invert the diluted dispersion 10 times. Do not shake.
•
The diluted vaccine should present as a white to off-white dispersion with no particulates
visible. Do not use the diluted vaccine if particulates or discolouration are present.
•
The diluted vials should be marked with the appropriate discard date and time.
•
After dilution, store at 2 ºC to 30 ºC and use within 12 hours.

•

Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion tocome to room temperature prior to use.

Preparation of 0.2 mL doses
72023-0088411

Pfleet no:

•
•
•

•
•
•

After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw 0.2 mL of Comirnaty Original/Omicron BA.4-5 for children aged 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 10 doses from asingle vial. The low dead-volume syringe and needle combination should have a dead volume ofno more than 35 microlitres. 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 of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard thevial and any excess volume.
Discard any unused vaccine within 12 hours after dilution.

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

82023-0088411

Pfleet no:

Package leaflet: Information for the user
Comirnaty 10 micrograms/dose concentrate for dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine
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 your child receives this vaccine because it contains
important information for your child.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your child’s doctor, pharmacist or nurse.
•
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes
any possible 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.
The use of this vaccine should be in accordance with official recommendations.
2.

What you need to know before your child receives Comirnaty

Comirnaty should not be given•
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 child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:•has ever had a severe allergic reaction or breathing problems after any other vaccine injection orafter having been given this vaccine in the past.
•is feeling nervous about the vaccination process or has ever fainted following any needle
injection.
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Pfleet No:•••

has a severe illness or infection with high fever. However, your child can have the vaccination if
he/she has a mild fever or upper airway infection like a cold.
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). These
conditions 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years comparedwith ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required
intensive care support and fatal cases have been seen. Following vaccination, you should be alert tosigns 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 how
long your child will be protected.
The efficacy of Comirnaty may be lower in people who are immunocompromised. If your child isimmunocompromised, he/she may receive additional doses of Comirnaty. In these cases, your childshould continue to maintain physical precautions to help prevent COVID-19. In addition, your child’s
close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations
with your child’s doctor.
ChildrenComirnaty 10 micrograms/dose concentrate for dispersion for injection is not recommended forchildren aged under 5 years.
There are paediatric formulations available for infants and children aged 6 months to 4 years. For
details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty
Tell your child’s 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 child’s 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.
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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 child’s ability to use machines or undertake activities such as cycling. Wait until theseeffects have worn off before resuming activities that require your child’s full attention.
3.

How Comirnaty is given

Comirnaty is given after dilution as an injection of 0.2 mL into a muscle of your child’s upper arm.
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine
before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of
Comirnaty until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty.
If you have any further questions on the use of Comirnaty, ask your child’s doctor, pharmacist or
nurse.
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 people•
injection site: pain, swelling•
tiredness, headache•
muscle pain, joint pain•
chills, fever•
diarrhoea
Common side effects: may affect up to 1 in 10 people•
nausea, vomiting•
injection site redness (‘very common’ in 5 to 11 years of age)•enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people•
feeling unwell, feeling weak or lack of energy/sleepy•
arm pain•insomnia•
injection site itching•allergic reactions such as rash or itching•
decreased appetite•dizziness•
excessive sweating, night sweats
Rare side effects: may affect up to 1 in 1 000 people•
temporary one sided facial drooping
32023-0088411

Pfleet No:•allergic reactions such as hives or swelling of the face

Very rare side effects: may affect up to 1 in 10 000 people•
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)•
severe allergic reaction•
extensive swelling of the vaccinated limb•
swelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)•a 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)•
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)•
decreased feeling or sensitivity, especially in the skin (hypoaesthesia)•
heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)
Reporting of side effects
If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
Ireland
You can also report side effects directly via HPRA Pharmacovigilance. Website: www.hpra.ie
United Kingdom (Northern Ireland)
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card
reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Comirnaty

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 or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
42023-0088411

Pfleet No:

Thawed (previously frozen) vials: 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 expiry date at 2 °C to 8 °C. Once thawed, thevaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and
30 °C.
Thawed vials can be handled in room light conditions.
After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes up to 6 hours
transportation time. 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 contains•
The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is calledtozinameran. After dilution, the vial contains 10 doses of 0.2 mL with 10 micrograms
tozinameran each.
•
The 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
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: 10 vials or 195 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de52023-0088411

Pfleet No:

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
IrelandPfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)+44 (0)1304 616161
United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161
This leaflet was last revised in 07/2024.
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu.
Ref: bCY/TS10 26_0-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly after dilution as a single dose of 0.2 mL regardless of prior
COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty should be
administered at least 3 months after the most recent dose of a COVID-19 vaccine.
62023-0088411

Pfleet No:

Additional doses may be given 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 prior to use
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure thesterility of the prepared dispersion.

•
•
•
•
•
•
•

Verify that the vial has an orange plastic cap and the product name is Comirnaty
10 micrograms/dose concentrate for dispersion for injection (children 5 to 11 years).
If the vial has another product name on the label, please make reference to the Summary of
Product Characteristics for that formulation.
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred toan environment of 2 °C to 8 °C to thaw; a 10-vial pack may take 4 hours to thaw. Ensure vials
are completely thawed prior to use.
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed
expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.

Dilution•
Allow the thawed vial to come to room temperature and gently invert it 10 times prior todilution. Do not shake.
•
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous
particles.
•
The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL(0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
•
Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL
air into the empty diluent syringe.
•
Gently invert the diluted dispersion 10 times. Do not shake.
•
The diluted vaccine should present as a white to off-white dispersion with no particulates
visible. Do not use the diluted vaccine if particulates or discolouration are present.
•
The diluted vials should be marked with the appropriate discard date and time.
•
After dilution, store at 2 ºC to 30 ºC and use within 12 hours.
•
Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion tocome to room temperature prior to use.
Preparation of 0.2 mL doses•
After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
•
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
•
Withdraw 0.2 mL of Comirnaty for children aged 5 to 11 years.
Low dead-volume syringes and/or needles should be used in order to extract 10 doses from asingle vial. The low dead-volume syringe and needle combination should have a dead volume ofno more than 35 microlitres. If standard syringes and needles are used, there may not be
sufficient volume to extract ten doses from a single vial.
72023-0088411

Pfleet No:

•••Each dose must contain 0.2 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard thevial and any excess volume.
Discard any unused vaccine within 12 hours after dilution.

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

82023-0088411

Pfleet No: