Comirnaty KP.2

Patient Information Leaflet: Information for the User

Comirnaty KP.2 30 micrograms/dose suspension for injectable suspension (vials

frozen)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
cemivameran
This medicinal product is subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while receiving
this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty KP.2 is and what it is used for
2. What you need to know before receiving Comirnaty KP.2
3. How Comirnaty KP.2 is administered
4. Possible side effects
5. How to store Comirnaty KP.2
6. Contents of the pack and other information

1. What Comirnaty KP.2 is and what it is used for

Comirnaty KP.2 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty KP.2 30 micrograms/dose dispersion for injectable preparation is administered to adults and adolescents aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty KP.2 does not contain the virus to induce immunity, it cannot transmit COVID-19.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before receiving Comirnaty KP.2

Comirnaty KP.2 must not be given

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving the vaccine if:

• you have had a severe allergic reaction or breathing problems after an injection of another vaccine or after previously receiving this vaccine;

• vaccination procedures make you anxious or you have fainted after an injection;

• you have a serious illness or infection with high fever. However, if you have a mild fever or
  a respiratory tract infection (such as a cold), you may still receive the
  vaccination;

• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;

• you have a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

Following vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation
of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see
section 4). These conditions may develop within a few days after vaccination and have
mostly occurred within 14 days. They have been observed more frequently after the second dose of
vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in
children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay particular attention to signs of
myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and contact
your doctor immediately if these symptoms occur.
As with all vaccines, Comirnaty KP.2 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty KP.2 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty KP.2. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Talk to your doctor about the recommendations most suitable for you.

Children
Comirnaty KP.2 30 micrograms/dose, dispersion for injectable preparation, is not recommended
in children under 12 years of age.
Paediatric formulations are available for infants and children aged 6 months and older and for children under 12 years of age. For details, refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty KP.2
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, or if you have recently received any other vaccines.
Comirnaty KP.2 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty KP.2 may be administered
simultaneously with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty KP.2 may be administered
simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty KP.2 may be administered
simultaneously with a high-dose influenza vaccine and an RSV vaccine.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine.
Data on the use of Comirnaty KP.2 in pregnant women are not yet available. However,
a large number of data from pregnant women vaccinated with the originally authorized Comirnaty
vaccine during the second and third trimesters of pregnancy have not shown any negative
effects on pregnancy or the newborn. Although data on effects on pregnancy or the
newborn following vaccination during the first trimester are limited, no change in the risk of
spontaneous abortion has been observed. Comirnaty KP.2 may be used during
pregnancy.
Data on the use of Comirnaty KP.2 during breastfeeding are not yet available. However,
the vaccine is not considered likely to cause effects in infants. Data from women who were
breastfeeding after administration of the originally authorized Comirnaty vaccine have
not shown any risk of adverse effects in infants. Comirnaty KP.2 may be used during
breastfeeding.

Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may
temporarily affect your ability to drive or operate machinery. Wait until these
effects have subsided before driving or operating machinery.

3. How Comirnaty KP.2 is administered

Comirnaty KP.2 is administered as a 0.3 mL intramuscular injection in the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID‑19 vaccine.
If you have previously been vaccinated with a COVID‑19 vaccine, you should not receive a dose of Comirnaty KP.2 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty KP.2.
If you have any doubts about the use of Comirnaty KP.2, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everybody gets them.

Very common side effects: may affect more than 1 in 10 people

• at the injection site: pain, swelling
• tiredness, headache
• muscle pain, joint pain
• chills, fever
• diarrhoea
  Some of these side effects were found to be slightly more frequent in adolescents aged 12 to 15 years compared to adults.

Common side effects: may affect up to 1 in 10 people

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years and older and in immunocompromised individuals aged 12 to 18 years)
• redness at the injection site (‘very common’ in immunocompromised individuals aged 12 years and older)
• swollen lymph nodes (observed more frequently after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• feeling unwell, feeling weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced appetite
• dizziness
• excessive sweating, night sweats

Rare side effects: may affect up to 1 in 1,000 people

• temporary paralysis of one side of the face
• 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 outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• swelling of the face (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may look like a target or “bull’s eye” with a dark red centre surrounded by lighter red rings (erythema multiforme)
• unusual sensation on the skin, such as tingling or pricking (paraesthesia)
• decreased sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient in nature)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Comirnaty KP.2

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry date, use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store frozen at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.

Single-dose vials: if stored frozen at a temperature between -90 °C and -60 °C, packs of 10 single-dose vials may be thawed at a temperature between 2 °C and 8 °C for 2 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.

Multi-dose vials: if stored frozen at a temperature between -90 °C and -60 °C, packs of 10 vials may be thawed at a temperature between 2 °C and 8 °C for 6 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.

Vials (previously frozen), after thawing: once removed from the freezer, the unopened vial may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.).
Mark on the outer carton the expiry date for storage at a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.

Before use, unopened vials may be kept at a temperature between 8 °C and 30 °C for up to 12 hours.
After thawing, vials may be handled under ambient light conditions.

Opened vials: after first puncture, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum possible transport time of 6 hours. Discard any unused vaccine.

Do not use this vaccine if you notice particles in the solution or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Comirnaty KP.2 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside modified) is called cemivameran.
  • A single-dose vial contains 1 dose of 0.3 mL, each dose containing 30 micrograms of cemivameran.
  • A multi-dose vial contains 6 doses of 0.3 mL, each dose containing 30 micrograms of cemivameran.
• 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
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty KP.2 and package contents
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in:

• a single-dose vial containing 1 dose in a 2 mL clear vial (Type I glass) with a rubber stopper and a grey removable plastic cap with an aluminium seal, or
• a multi-dose vial containing 6 doses in a 2 mL clear vial (Type I glass) with a rubber stopper and a grey removable plastic cap with an aluminium seal.

Pack of 10 single-dose vials.
Pack of 10 multi-dose vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Tel: +359 2 970 4333
• Česká republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Τηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00

Scan the code with a mobile device to access the package leaflet in other languages.

URL: www.comirnatyglobal.com
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

Administer Comirnaty KP.2 by intramuscular injection as a single 0.3 mL dose,
regardless of prior anti–COVID–19 vaccination status.
In individuals previously vaccinated with an anti–COVID–19 vaccine, Comirnaty KP.2 should be
administered at least 3 months after the most recent dose of anti–COVID–19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of
the administered product must be clearly documented.
Instructions for handling before use of frozen vials
Comirnaty KP.2 must be prepared by a healthcare professional using aseptic techniques to
ensure sterility of the prepared dispersion.

• Check that the vial has a grey plastic cap and that the product name is Comirnaty KP.2 30 micrograms/dose dispersion for injectable suspension (adults and children aged ≥ 12 years).
• If the vial has a different name on the label, refer to the summary of product characteristics for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials must be transferred to an environment at a temperature between 2 °C and 8 °C to thaw. Ensure that vials are completely thawed before use.
  • Single-dose vials: up to 2 hours may be required to thaw a pack of 10 single-dose vials.
  • Multi-dose vials: up to 6 hours may be required to thaw a pack of 10 multi-dose vials.
• When transferring the product to storage at 2 °C to 8 °C, update the expiry date on the carton.
• Closed vials may be stored at a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Prior to mixing, the thawed dispersion may contain opaque amorphous particles, white to off-white in color.
• After mixing, the vaccine should appear as a white to off-white dispersion, free from visible particles. Do not use the vaccine if particles are present or if discoloration occurs.
• Determine whether the vial is a single-dose or multi-dose vial, and follow the applicable handling instructions below:
  • Single-dose vials
  • Withdraw a single 0.3 mL dose of vaccine.
  • Discard the vial and any remaining volume.
  • Multi-dose vials
  • Multi-dose vials contain 6 doses of 0.3 mL each.
  • Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
  • Withdraw 0.3 mL of Comirnaty KP.2.
  • To extract 6 doses from a single vial, low dead-volume syringes and/or needles must be used. The syringe and needle combination must have a dead volume of no more than 35 microliters. When standard syringes and needles are used, the residual volume may be insufficient to withdraw a sixth dose from a single vial.
  • Each dose must contain 0.3 mL of vaccine.
  • If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any remaining volume.
  • Clearly record the date and time of first puncture on the vial. Discard any unused vaccine within 12 hours of the first puncture.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance with
local regulations.

Package leaflet: Information for the user

Comirnaty KP.2 30 micrograms/dose dispersion for injectable suspension (vials for refrigerated storage only)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
cemivameran
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while receiving this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty KP.2 is and what it is used for
2. What you need to know before receiving Comirnaty KP.2
3. How Comirnaty KP.2 is administered
4. Possible side effects
5. How to store Comirnaty KP.2
6. Contents of the pack and other information

1. What Comirnaty KP.2 is and what it is used for

Comirnaty KP.2 is a vaccine used to prevent COVID-19, a disease caused by
SARS-CoV-2.
Comirnaty KP.2 30 micrograms/dose dispersion for injectable preparation is administered to
adults and adolescents aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and
active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty KP.2 does not contain the virus to induce immunity, it cannot transmit COVID-19.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before receiving Comirnaty KP.2

Comirnaty KP.2 must not be given

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving the vaccine if:

• you have ever had a severe allergic reaction or breathing problems after an injection of another vaccine or after previously receiving this vaccine;

• getting vaccinated makes you feel anxious or you have fainted after an injection;

• you have a serious illness or infection with high fever. However, if you have a mild fever or
  a respiratory tract infection (such as a cold), you may still receive the
  vaccination;

• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;

• you have a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may develop a few days after vaccination and have mainly occurred within 14 days. They have been observed more frequently after the second dose of the vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay particular attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek immediate medical advice if these symptoms occur.
As with all vaccines, Comirnaty KP.2 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty KP.2 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty KP.2. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Talk to your doctor about the recommendations most suitable for you.

Children
Comirnaty KP.2 30 micrograms/dose, dispersion for injectable preparation, is not recommended for children under 12 years of age.
Paediatric formulations are available for infants aged 6 months and older and for children under 12 years of age. For details, refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty KP.2
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, or if you have recently received any other vaccines.
Comirnaty KP.2 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty KP.2 may be administered simultaneously with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty KP.2 may be administered simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty KP.2 may be administered simultaneously with a high-dose influenza vaccine and an RSV vaccine.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine.
Data on the use of Comirnaty KP.2 in pregnant women are not yet available. However, a large amount of data from pregnant women vaccinated with the originally authorized Comirnaty vaccine during the second and third trimesters of pregnancy have not shown negative effects on pregnancy or the newborn. Although data on effects on pregnancy or the newborn following vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty KP.2 may be used during pregnancy.
Data on the use of Comirnaty KP.2 during breastfeeding are not yet available. However, the vaccine is not expected to cause effects in newborns/infants. Data from breastfeeding women after administration of the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in newborns/infants. Comirnaty KP.2 may be used during breastfeeding.

Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or operate machinery. Wait until these effects have subsided before driving or operating machinery.

3. How Comirnaty KP.2 is given

Comirnaty KP.2 is administered as a 0.3 mL intramuscular injection in the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID-19 vaccine.
If you have previously been vaccinated with a COVID-19 vaccine, you must not receive a dose of Comirnaty KP.2 earlier than 3 months after your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty KP.2.
If you have any questions about the use of Comirnaty KP.2, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everyone experiences them.

Very common side effects: may affect more than 1 in 10 people

• at the injection site: pain, swelling
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhoea
  Some of these side effects were found to be slightly more frequent in adolescents aged 12 to 15 years compared to adults.

Common side effects: may affect up to 1 in 10 people

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years or older and in immunocompromised individuals aged 12 to 18 years)
• redness at the injection site (‘very common’ in immunocompromised individuals aged 12 years or older)
• enlarged lymph nodes (observed more frequently after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• feeling unwell, feeling weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced appetite
• dizziness
• excessive sweating, night sweats

Rare side effects: may affect up to 1 in 1,000 people

• temporary paralysis on one side of the face
• allergic reactions such as hives or facial swelling

Very rare side effects: may affect up to 1 in 10,000 people

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may appear target-shaped or “bull’s eye” with a dark red centre surrounded by lighter red rings (erythema multiforme)
• unusual sensations on the skin, such as tingling or prickling (paraesthesia)
• reduced sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Comirnaty KP.2

Keep this medicinal product out of the sight and reach of children.
The following information regarding storage, expiry, use and handling is intended for healthcare professionals.
Do not use this medicinal product after the expiry date stated on the carton and label after “Exp.”.
Store in a refrigerator at a temperature between 2 °C and 8 °C. DO NOT FREEZE.
Keep in the original packaging to protect the medicinal product from light.
Before use, unopened vials may be stored for up to 12 hours at a temperature between 8 °C and 30 °C and may be handled under ambient light conditions.
Opened vials: after first puncture, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum possible transport time of 6 hours. Discard any unused vaccine.
Do not use this vaccine if you notice the presence of particles in the diluent or any change in colour.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty KP.2 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleotide-modified) is called cemivameran. Each multidose vial contains 6 doses of 0.3 mL, each dose containing 30 micrograms of cemivameran.
• The other components 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
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty KP.2 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a 2 mL multidose vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap sealed with an aluminium seal.
Pack: 10 multidose vials.

Marketing Authorization Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

For further information about this medicine, please contact the local representative of the marketing authorization holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg : Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България : Пфайзер Люксембург САРЛ, Клон, България, Teл: +359 2 970 4333
• Česká republika : Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark : Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland : BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti : Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα : Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España : Pfizer, S.L., Tel: +34914909900
• France : Pfizer, Tél +33 1 58 07 34 40
• Hrvatska : Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland : Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland : Icepharma hf, Simi: +354 540 8000
• Italia : Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος : Pfizer Ελλάς Α.Ε. (Cyprus Branch), Tηλ: +357 22 817690
• Latvija : Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva : Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország : Pfizer Kft, Tel: +36 1 488 3700
• Malta : Vivian Corporation Ltd., Tel: +35621 344610
• Norge : Pfizer AS, Tlf: +47 67 526 100
• Nederland : Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich : Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska : Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal : Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija : Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika : Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland : Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige : Pfizer AB, Tel: +46 (0)8 550 520 00

Scan the code with a mobile device to access the package leaflet in other languages.

URL: www.comirnatyglobal.com
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty KP.2 by intramuscular injection as a single 0.3 mL dose,
regardless of prior anti-COVID-19 vaccination status.
In individuals previously vaccinated with an anti-COVID-19 vaccine, Comirnaty KP.2 should be
administered at least 3 months after the most recent anti-COVID-19 vaccine dose.
Additional doses may be administered to individuals who are severely immunocompromised.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered medicinal product must be clearly recorded.
Instructions for handling refrigerated vials prior to use
Comirnaty KP.2 must be prepared by a healthcare professional using aseptic techniques to
ensure sterility of the prepared dispersion.

• Check that the vial has a grey plastic flip-off cap and that the product name is Comirnaty KP.2 30 micrograms/dose dispersion for injectable suspension (for adults and children aged ≥ 12 years).
• If the vial label shows a different name, refer to the summary of product characteristics for that formulation.
• Closed vials are stored at 2 °C to 8 °C and must never be used beyond the printed expiry date (Exp.).
• Prior to use, the closed vial may be stored for up to 12 hours at a temperature not exceeding 30 °C and may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Before mixing, the dispersion may contain amorphous, opaque particles, white to off-white in colour.
• After mixing, the vaccine should appear as a white to off-white dispersion, free from visible particles. Do not use the vaccine if particles are present or if discoloration occurs.
• Multidose vials contain 6 doses of 0.3 mL each.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant swab.
• Withdraw 0.3 mL of Comirnaty KP.2. To extract 6 doses from a single vial, precision syringes and/or needles (low dead volume) must be used. The syringe and needle set must have a dead volume of no more than 35 microliters. When standard syringes and needles are used, the residual volume may be insufficient to withdraw a sixth dose from a single vial.
• Each dose must contain 0.3 mL of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any excess volume.
• Clearly record the date and time of first puncture on the vial. Discard any unused vaccine within 12 hours of first puncture.

Disposal
Any unused medicinal product and waste materials derived from its use must be disposed of in accordance with
local regulations.

Package leaflet: information for the user

Comirnaty KP.2 30 micrograms/dose, dispersion for injection in prefilled syringe (glass)

For adults and adolescents aged 12 years and older
mRNA COVID-19 vaccine
cemivameran
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty KP.2 is and what it is used for
2. What you need to know before receiving Comirnaty KP.2
3. How Comirnaty KP.2 is administered
4. Possible side effects
5. How to store Comirnaty KP.2
6. Contents of the pack and other information

1. What Comirnaty KP.2 is and what it is used for

Comirnaty KP.2 is a vaccine used to prevent COVID-19, a disease caused by
SARS-CoV-2.
Comirnaty KP.2 30 micrograms/dose dispersion for injectable suspension is administered to
adults and adolescents aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and
blood cells active against the virus, thereby providing protection against COVID-19.
Since Comirnaty KP.2 does not contain the virus to induce immunity, it cannot transmit COVID-19.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before receiving Comirnaty KP.2

Comirnaty KP.2 must not be given

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Speak to your doctor, pharmacist, or nurse before receiving the vaccine if:

• you have previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• you tend to feel faint or have fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or

a respiratory tract infection (such as a cold), you may still receive the
vaccination;

• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation
of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see
section 4). These conditions may develop within a few days after vaccination and have
mostly occurred within 14 days. They have been observed more frequently after the second dose of
vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in
children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay particular attention to signs of
myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and contact your
doctor immediately if these symptoms occur.
As with all vaccines, Comirnaty KP.2 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty KP.2 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty KP.2. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Discuss with your doctor the recommendations most suitable for you.
Children
Comirnaty KP.2 30 micrograms/dose, dispersion for injectable preparation is not recommended
in children under 12 years of age.
Paediatric formulations are available for infants and children aged 6 months and older and for children under 12 years of age. For details, refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.
Other medicines and Comirnaty KP.2
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, or if you have recently received any other vaccines.
Comirnaty KP.2 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty KP.2 may be administered
concomitantly with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty KP.2 may be administered
concomitantly with a respiratory syncytial virus (RSV) vaccine.
In older adults, aged 65 years and above, Comirnaty KP.2 may be administered
concomitantly with a high-dose influenza vaccine and an RSV vaccine.
Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine.
Data on the use of Comirnaty KP.2 in pregnant women are not yet available. However,
a large number of data from pregnant women vaccinated with the originally authorized Comirnaty
vaccine during the second and third trimesters of pregnancy have not shown any negative effects
on pregnancy or the newborn. Although data on effects on pregnancy or the newborn after
vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty KP.2 may be used during pregnancy.
Data on the use of Comirnaty KP.2 during breastfeeding are not yet available. However,
the vaccine is not considered likely to cause effects in newborns/infants. Data from women who were
breastfeeding after administration of the originally authorized Comirnaty vaccine have not
shown any risk of adverse effects in newborns/infants. Comirnaty KP.2 may be used during
breastfeeding.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may
temporarily affect your ability to drive vehicles or operate machinery. Wait until these
effects have subsided before driving or using machinery.

3. How Comirnaty KP.2 is given

Comirnaty KP.2 is administered as a 0.3 mL intramuscular injection in the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID-19 vaccine.
If you have previously been vaccinated with a COVID-19 vaccine, you should not receive a dose of Comirnaty KP.2 earlier than 3 months after your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty KP.2.
If you have any questions about the use of Comirnaty KP.2, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people

• at the injection site: pain, swelling
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhea. Some of these side effects have been reported slightly more frequently in adolescents aged 12 to 15 years compared to adults.

Common side effects: may affect up to 1 in 10 people

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years and older and in immunocompromised individuals aged 12 to 18 years)
• redness at the injection site (‘very common’ in immunocompromised individuals aged 12 years and older)
• enlarged lymph nodes (observed more frequently after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• malaise, feeling of weakness or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced appetite
• dizziness
• excessive sweating, night sweats

Rare side effects: may affect up to 1 in 1,000 people

• temporary paralysis on one side of the face
• allergic reactions such as hives or facial swelling

Very rare side effects: may affect up to 1 in 10,000 people

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may resemble a target or “bull’s eye” with a dark red center surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paresthesia)
• decreased sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases reported were non-serious and transient)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Comirnaty KP.2

Keep this medicinal product out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare
professionals.
Do not use this medicinal product after the expiry date stated on the carton and label after “Exp.”.
Store in a refrigerator at a temperature between 2 °C and 8 °C. DO NOT FREEZE.
Store in the original packaging to protect the medicinal product from light.
The vaccine will be supplied at a temperature between 2 °C and 8 °C (refrigerated only).
Before use, the prefilled syringes may be stored for up to 12 hours at temperatures between 8 °C and
30 °C and may be handled under ambient light conditions.
Do not use this vaccine if you observe particles in the dispersion or any change in colour.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty KP.2 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called cemivameran.
  • Each pre-filled syringe contains 1 dose of 0.3 mL, each containing 30 micrograms of cemivameran.
• The other components 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
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty KP.2 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a pre-filled syringe (Type I glass syringe) with a plunger stopper (synthetic bromobutyl rubber) and protective cap (synthetic bromobutyl rubber), without needle.
Pack containing 10 pre-filled syringes.

Marketing Authorization Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Teл: +359 2 970 4333
• Česká republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Tηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00

Scan the code with a mobile device to access the package leaflet in other languages.

URL: www.comirnatyglobal.com
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.

---

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty KP.2 by intramuscular injection as a single 0.3 mL dose,
regardless of prior COVID-19 vaccination status.
In individuals previously vaccinated with a COVID-19 vaccine, Comirnaty KP.2 should be
administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the
administered product must be clearly recorded.
Instructions for handling prior to use
Comirnaty KP.2 must be prepared by a healthcare professional using aseptic techniques to
ensure sterility of the prepared dispersion.
Instructions for prefilled syringes
Prefilled glass syringes

• Prior to use, prefilled glass syringes may be stored for up to 12 hours at temperatures between 8 °C and 30 °C, and may be handled under ambient light conditions.
• Remove the protective cap by slowly turning it counterclockwise. Do not shake. Attach a suitable needle for intramuscular injection, and administer the entire volume.

Disposal
Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local requirements.

Package leaflet: information for the user

Comirnaty KP.2 10 micrograms/dose dispersion for injectable suspension

Children aged 5 to 11 years
Anti-COVID-19 mRNA vaccine
cemivameran
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects experienced by the child while receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before the child receives this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the paediatrician, pharmacist, or nurse.
• If the child experiences any side effects, including those not listed in this leaflet, consult the paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty KP.2 is and what it is used for
2. What you should know before your child receives Comirnaty KP.2
3. How Comirnaty KP.2 is administered
4. Possible side effects
5. How to store Comirnaty KP.2
6. Contents of the pack and other information

1. What Comirnaty KP.2 is and what it is used for

Comirnaty KP.2 is a vaccine used to prevent COVID-19, a disease caused by
SARS-CoV-2.
Comirnaty KP.2 10 micrograms/dose suspension for injectable preparation is administered to
children aged 5 to 11 years.
The vaccine prompts the immune system (the body's natural defences) to produce antibodies and
active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty KP.2 does not contain the virus to induce immunity, it cannot transmit COVID-19
to the child.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before your child receives Comirnaty KP.2

Comirnaty KP.2 must not be given

• if your child is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your paediatrician, pharmacist, or nurse before your child receives the vaccine if your child:

• has previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• feels anxious about the vaccination procedure or has fainted after an injection;
• has a serious illness or infection with high fever. However, if your child has a mild fever or a respiratory tract infection (such as a cold), vaccination can still be given;
• has a bleeding disorder, a tendency to bruise easily, or is taking medicines to prevent blood clots;
• has a weakened immune system due to an illness such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may develop within a few days after vaccination and have mostly occurred within 14 days. They have been observed more frequently after the second dose of the vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay close attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek immediate medical attention if these symptoms occur.
As with all vaccines, Comirnaty KP.2 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty KP.2 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty KP.2 may be administered. In such cases, your child should continue to follow physical precautions to help prevent COVID-19. Where appropriate, close contacts of your child should also be vaccinated. Talk to your paediatrician about the most suitable recommendations for your child.

Children
Comirnaty KP.2 10 micrograms/dose, dispersion for injectable preparation, is not recommended for children under 5 years of age.
Paediatric formulations are available for infants and children aged 6 months to 4 years. For details, refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty KP.2
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines, or if your child has recently received any other vaccines.

Pregnancy and breastfeeding
If the girl is pregnant, inform the paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty KP.2 in pregnant women are not yet available. However, a large amount of data from pregnant women vaccinated during the second and third trimesters of pregnancy with the originally authorised Comirnaty vaccine have not shown any negative effects on pregnancy or the newborn. Although data on effects on pregnancy or the newborn following vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty KP.2 may be used during pregnancy.
Data on the use of Comirnaty KP.2 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in breastfed infants. Data from women who were breastfeeding after administration of the originally authorised Comirnaty vaccine have not shown any risk of adverse effects in infants. Comirnaty KP.2 may be used during breastfeeding.

Driving and using machines
Some of the side effects mentioned in section 4 (Possible side effects) may temporarily affect your child’s ability to use machinery or perform activities such as riding a bicycle. Your child should wait until these effects have passed before resuming activities requiring full attention.

3. How Comirnaty KP.2 is administered

Comirnaty KP.2 is administered as a 0.3 mL intramuscular injection into the upper arm of the child.
The child will receive 1 injection, regardless of whether they have previously received a COVID-19 vaccine.
If the child has previously been vaccinated with a COVID-19 vaccine, they should not receive a dose of Comirnaty KP.2 until at least 3 months have passed since their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty KP.2 may be administered.
If you have any questions about the use of Comirnaty KP.2, consult the child's pediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everybody gets them.

Very common side effects: may affect more than 1 in 10 people

• at the injection site: pain, swelling
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhoea

Common side effects: may affect up to 1 in 10 people

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years and older and in immunocompromised individuals aged 5 to 18 years)
• redness at the injection site (‘very common’ in individuals aged 5 to 11 years and in immunocompromised individuals aged 5 years and older)
• swollen lymph nodes (observed more frequently after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• feeling unwell, feeling weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced appetite
• dizziness
• excessive sweating
• night sweats

Rare side effects: may affect up to 1 in 1,000 people

• temporary facial paralysis (Bell’s palsy)
• allergic reactions such as hives or facial swelling

Very rare side effects: may affect up to 1 in 10,000 people

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may look like a target or “bull’s eye” with a dark red centre surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• reduced sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-severe and transient in nature)

Reporting of side effects
If your child experiences any side effects, including those not listed in this leaflet, please contact your paediatrician, pharmacist, or nurse. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Comirnaty KP.2

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiration, use, and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.

Single-dose vials: If stored frozen at a temperature between -90 °C and -60 °C, packs of 10 single-dose vials of vaccine may be thawed at a temperature between 2 °C and 8 °C for 2 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.

Multi-dose vials: If stored frozen at a temperature between -90 °C and -60 °C, packs of 10 vaccine vials may be thawed at a temperature between 2 °C and 8 °C for 6 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.

Thawed vials (previously frozen): Once removed from the freezer, the unopened vial may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without ever exceeding the printed expiry date (Exp.). Mark the new expiry date for storage at 2 °C to 8 °C on the outer carton. Once thawed, the vaccine must not be refrozen.

Before use, unopened vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under ambient light conditions.

Opened vials: After first puncture, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum transport time of 6 hours. Discard any unused vaccine.

Do not use this vaccine if you notice the presence of particles in the solution or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty KP.2 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called cemivameran.
  • A single-dose vial contains 1 dose of 0.3 mL, containing 10 micrograms of cemivameran per dose.
  • A multi-dose vial contains 6 doses of 0.3 mL, containing 10 micrograms of cemivameran per dose.
• The other components 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
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty KP.2 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9) ranging from clear to slightly opalescent, supplied in:

• a single-dose vial containing 1 dose in a 2 mL transparent vial (Type I glass) with a rubber stopper and a removable blue plastic cap secured with an aluminium seal; or
• a multi-dose vial containing 6 doses in a 2 mL transparent vial (Type I glass) with a rubber stopper and a removable blue plastic cap secured with an aluminium seal.

Pack of 10 single-dose vials.
Pack of 10 multi-dose vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Teл: +359 2 970 4333
• Česká republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Tηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00

Scan the code with a mobile device to access the package leaflet in other languages.

URL: www.comirnatyglobal.com
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

Administer Comirnaty KP.2 by intramuscular injection as a single 0.3 mL dose,
regardless of prior anti-COVID-19 vaccination status.
In individuals previously vaccinated with an anti-COVID-19 vaccine, Comirnaty KP.2 should be
administered at least 3 months after the most recent dose of anti-COVID-19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered product must be clearly documented.
Instructions for handling prior to use
Comirnaty KP.2 must be prepared by a healthcare professional using aseptic techniques to
ensure sterility of the prepared dispersion.

• Check that the vial has a blue plastic cap and that the product name is Comirnaty KP.2 10 micrograms/dose dispersion for injectable suspension (for children aged 5–11 years).
• If the vial label displays a different name, refer to the summary of product characteristics for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C for thawing. Ensure vials are completely thawed before use.
  • Single-dose vials: up to 2 hours may be required to thaw a pack of 10 single-dose vials.
  • Multi-dose vials: up to 6 hours may be required to thaw a pack of 10 multi-dose vials.
• When transferring the product to storage at 2 °C to 8 °C, update the expiration date on the carton.
• Closed vials may be stored at 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Prior to mixing, the thawed dispersion may contain amorphous opaque particles, white to off-white in color.
• After mixing, the vaccine should appear as a dispersion ranging from clear to slightly opalescent, free from visible particles. If particles are present or if discoloration occurs, do not use the vaccine.
• Determine whether the vial is a single-dose or multi-dose vial, and follow the applicable handling instructions below:
  • Single-dose vials
  • Withdraw a single 0.3 mL dose of vaccine.
  • Discard the vial and any remaining volume.
  • Multi-dose vials
  • Multi-dose vials contain 6 doses of 0.3 mL each.
  • Using aseptic techniques, clean the vial stopper with a single-use disinfectant swab.
  • Withdraw 0.3 mL of Comirnaty KP.2 for children aged 5 to 11 years.
  • To extract 6 doses from a single vial, precision syringes and/or needles (low dead volume) must be used. The syringe-needle combination must have a dead volume of no more than 35 microliters. When standard syringes and needles are used, the residual volume may be insufficient to withdraw a sixth dose from a single vial.
  • Each dose must contain 0.3 mL of vaccine.
  • If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any remaining volume.
  • Clearly document the date and time of first puncture on the vial. Discard any unused vaccine within 12 hours of first puncture.

Disposal
Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Comirnaty KP.2 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
mRNA COVID-19 vaccine
cemivameran
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any adverse reactions observed in the child while receiving this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before the child receives this vaccine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your paediatrician, pharmacist, or nurse.
• If the child experiences any adverse reaction, including those not listed in this leaflet, consult your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty KP.2 is and what it is used for
2. What you should know before the child receives Comirnaty KP.2
3. How Comirnaty KP.2 is administered
4. Possible adverse reactions
5. How to store Comirnaty KP.2
6. Contents of the pack and other information

1. What Comirnaty KP.2 is and what it is used for

Comirnaty KP.2 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty KP.2 3 micrograms/dose concentrate for injectable dispersion is administered to young children aged 6 months to 4 years.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and blood cells active against the virus, thereby providing protection against COVID-19.
Since Comirnaty KP.2 does not contain the virus to induce immunity, it cannot transmit COVID-19 to the child.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before your child receives Comirnaty KP.2

Comirnaty KP.2 must not be given

• if your child is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your paediatrician, pharmacist, or nurse before your child receives the vaccine if your child:

• has previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine;
• feels anxious about the vaccination procedure or has fainted after an injection;
• has a serious illness or infection with high fever. However, if your child has a mild fever or a mild upper respiratory tract infection (such as a cold), vaccination may still proceed;
• has a bleeding disorder, a tendency to bruise easily, or is taking medicines to prevent blood clots;
• has a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may occur a few days after vaccination and have mostly been observed within 14 days. They have occurred more frequently after the second dose of the vaccine and more commonly in younger males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis have resolved. Some cases required intensive care support and fatal cases have been reported. After vaccination, pay close attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek immediate medical advice if any of these symptoms occur.
As with all vaccines, Comirnaty KP.2 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty KP.2 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty KP.2 may be administered. In such cases, your child should continue to follow physical precautions to help prevent COVID-19. Where appropriate, close contacts of your child should also be vaccinated. Talk to your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty KP.2 3 micrograms/dose concentrate for injectable dispersion is not recommended for children aged 5 to 11 years.
Paediatric formulations are available for children aged 5 to 11 years. For details, please refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty KP.2
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines, or if your child has recently received any other vaccine.

Pregnancy and breastfeeding
Comirnaty KP.2 3 micrograms/dose concentrate for injectable dispersion is not intended for individuals over 5 years of age.
For details on use in individuals over 5 years of age, please refer to the package leaflet of the corresponding formulations.

Driving and using machines
Some of the side effects mentioned in section 4 (Possible side effects) may temporarily affect your child’s ability to use machinery or to carry out activities such as riding a bicycle. Your child should wait until these effects have passed before resuming activities requiring full attention.

3. How Comirnaty KP.2 is administered

If the child is between 6 months and less than 12 months of age, they will receive Comirnaty KP.2 with yellow cap after dilution as an intramuscular injection of 0.3 mL in the thigh. In early childhood, or if the child is 1 year of age or older, they will receive Comirnaty KP.2 with yellow cap after dilution as an intramuscular injection of 0.3 mL in the thigh or upper arm.

If the child has not completed a primary series of anti-COVID-19 vaccination or has not previously had a COVID-19 infection, they will receive up to 3 injections (the total number of doses scheduled as the primary series). It is recommended that the second dose be given 3 weeks after the first dose, followed by a third dose administered at least 8 weeks after the second dose to complete the primary series.

If the child has previously completed a primary anti-COVID-19 vaccination series or has had COVID-19, they will receive 1 injection. If the child has previously been vaccinated with an anti-COVID vaccine, they should not receive a dose of Comirnaty KP.2 until at least 3 months have passed since the most recent dose.

If the child turns 5 years old between doses during the primary series, they should complete the primary series by continuing to receive the 3-microgram dose.

If the child is immunocompromised, additional doses of Comirnaty KP.2 may be administered.

Interchangeability
The child may receive any previous or current Comirnaty vaccine. The child should not receive more doses than the total number scheduled as the primary series. The primary series should be administered only once.

If you have any questions about the use of Comirnaty KP.2, consult your paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everybody experiences them.

Very common side effects: may affect more than 1 in 10 people

• irritability (in children aged 6 months to less than 2 years)
• at the injection site: pain/tenderness, swelling
• fatigue, headache
• sleepiness (in children aged 6 months to less than 2 years)
• muscle pain, joint pain
• chills, fever
• diarrhoea

Common side effects: may affect up to 1 in 10 people

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years and older and in immunocompromised individuals aged 2 to 18 years)
• redness at the injection site (‘very common’ in individuals aged 6 months to 11 years and in immunocompromised individuals aged 2 years and older)
• enlarged lymph nodes (observed more frequently after a booster dose)

Uncommon side effects: may affect up to 1 in 100 people

• malaise, feeling weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash (‘common’ in individuals aged 6 months to less than 2 years) or itching
• reduced appetite (‘very common’ in children aged 6 months to less than 2 years)
• dizziness
• excessive sweating, night sweats

Rare side effects: may affect up to 1 in 1,000 people

• temporary facial paralysis (Bell's palsy)
• allergic reactions such as hives or facial swelling

Very rare side effects: may affect up to 1 in 10,000 people

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may appear target-shaped or like a "bull's eye" with a dark red center surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or pricking (paraesthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient)

Reporting of side effects
If your child experiences any side effects, including those not listed in this leaflet, please contact your paediatrician, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Comirnaty KP.2

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store frozen at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.
If stored frozen between -90 °C and -60 °C, packs of 10 vials may be thawed at 2 °C to 8 °C for up to 2 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.
Vials (previously frozen), after thawing: once removed from the freezer, the closed vial may be stored and transported refrigerated at 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.).
Mark the external carton with the expiry date for storage at 2 °C to 8 °C. After thawing, the vaccine must not be refrozen.
Before use, closed vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under normal indoor lighting conditions.
After dilution, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum transport time of 6 hours. Discard any unused vaccine.
Do not use this vaccine if you notice particles in the diluted solution or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty KP.2 contains

• The active substance of the nucleoside-modified mRNA COVID-19 vaccine is called cemivameran. After dilution, the vial with a yellow flip-off cap contains 3 doses of 0.3 mL each, with each dose containing 3 micrograms of cemivameran.
• The other components 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
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty KP.2 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9), ranging from clear to slightly opalescent.
It is supplied in a multidose vial containing 3 doses in a 2 mL clear glass vial (Type I glass) with a
rubber stopper and removable yellow plastic flip-off cap with an aluminium seal.
Pack: 10 vials.

Marketing Authorization Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]

Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 – 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Teл: +359 2 970 4333
• Česká republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Tηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00

Scan the code with a mobile device to access the package leaflet in other languages.

URL: www.comirnatyglobal.com
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

If the child has not completed a primary series of anti-COVID-19 vaccination or does not have a history of prior SARS-CoV-2 infection, administer Comirnaty KP.2 intramuscularly after dilution as a primary series of up to 3 doses (the total number of doses intended for the primary series); the second dose should be administered 3 weeks after the first dose, and the third dose should be administered at least 8 weeks after the second dose to complete the primary series.
If the child has previously completed a primary anti-COVID-19 vaccination series or has a history of prior SARS-CoV-2 infection, administer Comirnaty KP.2 intramuscularly after dilution as a single dose of 0.3 mL. If the individual has previously been vaccinated with an anti-COVID-19 vaccine, the Comirnaty KP.2 dose should be administered at least 3 months after the most recent dose.
Additional doses may be administered to individuals who are severely immunocompromised.

Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product must be clearly recorded.

Instructions for handling prior to use
Comirnaty KP.2 must be prepared by a healthcare professional using aseptic techniques to ensure sterility of the prepared dispersion.

• Check that the vial has a yellow plastic cap and that the name of the product is Comirnaty KP.2 3 micrograms/dose concentrate for injectable dispersion (infants, children aged 6 months to 4 years).
• If the vial label displays a different name or if the cap has a different color, refer to the product characteristics summary for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C to thaw. Thawing may take up to 2 hours for a pack of 10 vials. Ensure vials are completely thawed before use.
• When transferring the product to storage at 2 °C to 8 °C, update the expiration date on the carton.
• Closed vials may be stored at a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Before dilution, the thawed dispersion may contain amorphous opaque particles, white to off-white in color.
• The thawed vaccine must be diluted within the original vial with 1.1 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, using a 21-gauge (or finer) needle and aseptic techniques.
• Equalize pressure in the vial before removing the needle from the vial stopper by withdrawing 1.1 mL of air into the empty solvent syringe.
• Gently invert the diluted dispersion 10 times. Do not shake.
• The diluted vaccine should appear as a dispersion ranging from clear to slightly opalescent, free from visible particles. Do not use the diluted vaccine if particulate matter is present or if discoloration occurs.
• After dilution, clearly mark the date and time of expiration of the diluted dispersion on the vial.
• After dilution, store at a temperature between 2 °C and 30 °C and use within 12 hours.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to reach room temperature before administration.

Preparation of 0.3 mL doses

• After dilution, the vial contains 1.58 mL, from which 3 doses of 0.3 mL can be withdrawn.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
• Withdraw 0.3 mL of Comirnaty KP.2 for infants, children aged 6 months to 4 years. To withdraw 3 doses from a single vial, standard syringes and/or needles may be used.
• Each dose must contain 0.3 mL of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete dose of 0.3 mL, discard the vial and any excess volume.
• Discard any unused vaccine within 12 hours after dilution.

Disposal
Any unused medicinal product and waste materials derived from it must be disposed of in accordance with local regulations.