Comirnaty LP.8.1

Package leaflet: Information for the user

Comirnaty LP.8.1 30 micrograms/dose concentrate for dispersion for injection (vials

frozen)
Adults and adolescents from 12 years of age
COVID-19 mRNA vaccine
mRNA encoding LP.8.1
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 experience while receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you are given this vaccine because 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 get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

What is in this leaflet

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before you receive Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is given
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty LP.8.1 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 active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty LP.8.1 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 LP.8.1

Comirnaty LP.8.1 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 previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• you feel anxious about the vaccination procedure 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 mild upper respiratory tract infection (such as a cold), you may still be vaccinated;
• 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 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 attention if these symptoms occur.
As with all vaccines, Comirnaty LP.8.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty LP.8.1. 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 LP.8.1 30 micrograms/dose injectable dispersion is not recommended for 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 LP.8.1
Tell 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 vaccine.
Comirnaty LP.8.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered at the same time as a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered at the same time as a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and older, Comirnaty LP.8.1 may be administered at the same time as a high-dose influenza vaccine and an RSV vaccine.

Pregnancy and breastfeeding
If you are pregnant or think you might be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine.
Data on the use of Comirnaty LP.8.1 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 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 LP.8.1 may be used during pregnancy.
Data on the use of Comirnaty LP.8.1 during breastfeeding are not yet available. However, the vaccine is not expected to cause effects in breastfed infants. Data from women who were breastfeeding after receiving the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in breastfed infants. Comirnaty LP.8.1 may be used during breastfeeding.

Driving and using machines
Some of the side 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 using machinery.

3. How Comirnaty LP.8.1 is administered

Comirnaty LP.8.1 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 LP.8.1 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty LP.8.1.
If you have any questions about the use of Comirnaty LP.8.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 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
• diarrhea
  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

• malaise, 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 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 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 (paresthesia)
• decreased sensation, especially in the skin (hypoesthesia)
• heavy menstrual flow (most cases were non-severe and transient)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact 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 LP.8.1

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 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.
If stored frozen between -90 °C and -60 °C, packs of 10 vials may be thawed and stored at 2 °C to 8 °C for up to 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 closed 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 on the outer carton the expiry date for storage at 2 °C to 8 °C. Once thawed, the vaccine must not be refrozen.
Before use, closed 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 normal room 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 LP.8.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called mRNA encoding LP.8.1.
  • A multidose vial contains 6 doses of 0.3 mL each, each dose containing 30 micrograms of mRNA encoding LP.8.1.
• 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-distearyl-sn-glycero-3-phosphocholine (DSPC)
  • cholesterol
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty LP.8.1 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 grey plastic flip-off cap with an aluminium seal.
Pack size: 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 European Medicines Agency website: https://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

Administer Comirnaty LP.8.1 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 LP.8.1 should be
administered at least 3 months after the most recent dose of any 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 frozen vials prior to use
Comirnaty LP.8.1 must be prepared by a healthcare professional using aseptic techniques to
ensure the sterility of the prepared dispersion.

• Check that the vial has a grey plastic cap and that the product name is Comirnaty LP.8.1 30 micrograms/dose dispersion for injectable suspension (for adults and children aged ≥ 12 years).
• If the vial label displays a different name, 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 a temperature between 2 °C and 8 °C for thawing. Ensure that vials are completely thawed before use. Thawing of a pack of 10 multidose vials may take up to 6 hours.
• When transferring the product to storage at 2 °C to 8 °C, update the expiry date on the carton accordingly.
• Closed vials may be stored at 2 °C to 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, the closed vial 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 white to off-white dispersion, free from visible particles. Do not use the vaccine if particles are present or if discoloration occurs.
• Using aseptic techniques, clean the vial stopper with a single-use antiseptic wipe.
• Withdraw 0.3 mL of Comirnaty LP.8.1.
• 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 not exceeding 35 microliters. When using standard syringes and needles, the residual volume may not be sufficient to extract 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 ensure a complete 0.3 mL dose, discard the vial and any excess volume.
• Clearly record the date and time of expiry on the vial. Discard any unused vaccine within 12 hours of first puncture.

Disposal
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 LP.8.1 30 micrograms/dose dispersion for injectable suspension (refrigerated vials only)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
mRNA encoding LP.8.1
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 experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before receiving this vaccine because 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before receiving Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty LP.8.1 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 LP.8.1 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 need to know before receiving Comirnaty LP.8.1

Comirnaty LP.8.1 must not be given

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

Warnings and precautions
Talk 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 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 attention if these symptoms occur.
As with all vaccines, Comirnaty LP.8.1 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty LP.8.1. In such cases, you should continue to take 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 LP.8.1 30 micrograms/dose suspension 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 LP.8.1
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 vaccine.
Comirnaty LP.8.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered simultaneously with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults, aged 65 years and older, Comirnaty LP.8.1 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 LP.8.1 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 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 LP.8.1 may be used during pregnancy.
Data on the use of Comirnaty LP.8.1 during breastfeeding are not yet available. However, the vaccine is not expected to cause effects in infants. Data from breastfeeding women after administration of the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in infants. Comirnaty LP.8.1 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 ability to drive or use machines. Wait until these effects have passed before driving or using machines.

3. How Comirnaty LP.8.1 is given

Comirnaty LP.8.1 is administered as a 0.3 mL intramuscular injection into the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID‑19 vaccine.
If you have already been vaccinated with a COVID‑19 vaccine, you should not receive a dose of Comirnaty LP.8.1 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty LP.8.1.
If you have any questions about the use of Comirnaty LP.8.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 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

Some of these side effects were 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 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 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 flow (most cases were non-serious and transient in nature)

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 LP.8.1

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 following "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 medicine 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 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 LP.8.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called mRNA encoding LP.8.1. Each multidose vial contains 6 doses of 0.3 mL, each dose containing 30 micrograms of mRNA encoding LP.8.1.
• 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 LP.8.1 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 grey plastic flip-off cap sealed with an aluminium seal. Each vial contains 6 doses.
Pack size: 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 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, 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), 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 LP.8.1 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 LP.8.1 should be
administered at least 3 months after the most recent dose of any COVID-19 vaccine.
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 refrigerated vials prior to use
Comirnaty LP.8.1 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 LP.8.1 30 micrograms/dose dispersion for injectable suspension (adults and children aged ≥ 12 years).
• If the vial displays a different name on the label, refer to the product characteristics summary for that formulation.
• Closed vials are stored at 2 °C to 8 °C and must never be used beyond the printed expiration date (Exp.).
• Prior to use, the closed vial may be kept 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.
• Prior to mixing, the dispersion may contain amorphous, opaque particles ranging in color from white to off-white.
• 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 wipe.
• Withdraw 0.3 mL of Comirnaty LP.8.1. 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 using standard syringes and needles, 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 ensure a complete 0.3 mL dose, discard the vial and any excess volume.
• Clearly mark the expiration date and time on the vial. Discard any unused vaccine within 12 hours after the 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 LP.8.1 30 micrograms/dose injectable dispersion for injection in pre-filled syringe (glass)

For adults and adolescents aged 12 years and older
mRNA COVID-19 vaccine
mRNA encoding LP.8.1
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before receiving Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty LP.8.1 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 LP.8.1 does not contain the virus needed 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 LP.8.1

Comirnaty LP.8.1 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 previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• vaccination makes you feel anxious or you have previously fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or an upper 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 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 LP.8.1 may not fully protect all individuals who receive it, and the
duration of protection is not known.
The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If you
are immunocompromised, you may be given additional doses of Comirnaty LP.8.1. 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 LP.8.1 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 LP.8.1
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 LP.8.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered simultaneously with a
pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty LP.8.1 may be administered simultaneously with a
respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and older, Comirnaty LP.8.1 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 LP.8.1 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 shown no 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 LP.8.1 may be used during pregnancy.
Data on the use of Comirnaty LP.8.1 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 LP.8.1 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 operating machinery.

3. How Comirnaty LP.8.1 is administered

Comirnaty LP.8.1 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 LP.8.1 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty LP.8.1.
If you have any questions about the use of Comirnaty LP.8.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people

• at 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 and older and in immunocompromised individuals aged 12 to 18 years)
• redness at 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 unwell or lack of energy/sleep
• arm pain
• insomnia
• itching at 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 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 look like a target or “bull’s eye” with a dark red center surrounded by light red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• reduced sensation, especially in the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient in nature)

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 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 LP.8.1

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.”.
Store in a refrigerator at a temperature between 2 °C and 8 °C. DO NOT FREEZE.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied at a temperature between 2 °C and 8 °C (refrigerated only).
Before use, the pre-filled 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 notice the presence of particles in the dispersion or any change in colour.
Do not dispose of any medicine 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 LP.8.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside modified) is called mRNA encoding LP.8.1.
  • Each pre-filled syringe contains 1 dose of 0.3 mL, each containing 30 micrograms of mRNA encoding LP.8.1.
• 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 LP.8.1 and package contents
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 a protective cap (synthetic bromobutyl rubber), without a needle.
Pack of 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, 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), 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 for healthcare professionals only:

Administer Comirnaty LP.8.1 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 LP.8.1 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
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 LP.8.1 must be prepared by a healthcare professional using aseptic techniques to
ensure the 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 needle suitable for intramuscular injection, and administer the entire volume.

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

Package leaflet: information for the user

Comirnaty LP.8.1 10 micrograms/dose concentrate for dispersion for injection

Children aged 5 to 11 years
Anti-COVID-19 mRNA vaccine
mRNA encoding LP.8.1
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 observe in the child 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 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 LP.8.1 is and what it is used for
2. What you need to know before the child receives Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty LP.8.1 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 LP.8.1 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 LP.8.1

Comirnaty LP.8.1 must not be administered

• if the 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 the
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;
• becomes anxious or faints due to the vaccination procedure;
• has a serious illness or infection with high fever. However, if the child has a mild fever or an upper respiratory tract infection (such as a cold), vaccination may 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 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 occur a few days after vaccination and have mainly been
reported 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 between 5 and 11 years compared to those aged between 12 and 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 any of these symptoms occur.
As with all vaccines, Comirnaty LP.8.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If the
child is immunocompromised, additional doses of Comirnaty LP.8.1 may be administered. In such
cases, the child should continue to maintain physical precautions to help prevent COVID-19. If appropriate, close contacts of the child should also be vaccinated. Discuss with your paediatrician the recommendations most suitable for your child.
Children
Comirnaty LP.8.1 10 micrograms/dose, injectable dispersion is not recommended
for children under 5 years of age.
Paediatric formulations are available for infants and children aged between 6 months and 4 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 LP.8.1
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines, or if they have recently received any other vaccines.
Pregnancy and breastfeeding
If the girl is pregnant, inform your paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty LP.8.1 in pregnant women are not yet available.
However, a large number of data from pregnant women vaccinated during the second and third
trimesters 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 LP.8.1 may be used during pregnancy.
Data on the use of Comirnaty LP.8.1 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 newborns/infants. Comirnaty LP.8.1 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 the child’s ability to use machinery or perform activities such as cycling. The child should wait until these effects have subsided before resuming activities requiring full attention.

3. How Comirnaty LP.8.1 is administered

Comirnaty LP.8.1 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 must not receive a dose of Comirnaty LP.8.1 until at least 3 months have passed since the most recent dose.
If the child is immunocompromised, additional doses of Comirnaty LP.8.1 may be administered.
If you have any questions about the use of Comirnaty LP.8.1, consult the child's pediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 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

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 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 or 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 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 appear target-shaped or “bull’s eye” with a dark red center surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual flow (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, speak to your paediatrician, 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 LP.8.1

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 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 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 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.

Vials (previously frozen), after thawing: Once removed from the freezer, the closed vial may be stored and transported refrigerated at a temperature between 2 °C and 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 a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.
Prior to 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 lighting 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 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 LP.8.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called mRNA encoding LP.8.1.
  • One single-dose vial contains 1 dose of 0.3 mL, containing 10 micrograms of mRNA encoding LP.8.1 per dose.
  • One multidose vial contains 6 doses of 0.3 mL, containing 10 micrograms of mRNA encoding LP.8.1 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 LP.8.1 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 sealed with an aluminium seal; or
• a multidose vial containing 6 doses in a 2 mL transparent vial (Type I glass) with a rubber stopper and a removable blue plastic cap sealed with an aluminium seal.

Pack of 10 single-dose vials.
Pack of 10 multidose 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 medicinal product, 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, 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 European Medicines Agency website, https://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

Administer Comirnaty LP.8.1 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 LP.8.1 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 medicinal product must be clearly recorded.
Instructions for handling prior to use
Comirnaty LP.8.1 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 LP.8.1 10 micrograms/dose dispersion for injectable suspension (children aged 5–11 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 should be transferred to a temperature between 2 °C and 8 °C for thawing. 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 kept 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. Do not use the vaccine if particles are present or if discoloration occurs.
• Check 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 LP.8.1 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 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 not be sufficient 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 ensure 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 first puncture.

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

Package leaflet: information for the user

Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
Anti-COVID-19 mRNA vaccine
mRNA encoding LP.8.1
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. 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 reactions, including those not listed in this leaflet, contact your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before your child receives Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Package contents and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty LP.8.1 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 active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty LP.8.1 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 LP.8.1

Comirnaty LP.8.1 must not be administered

• if the 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;
• becomes agitated due to vaccination procedures or has previously fainted after an injection;
• has a serious illness or infection with high fever. However, if the child has a mild fever or a 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 an illness 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 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 LP.8.1 may not fully protect all individuals who receive it, and the duration of protection is unknown.
The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If the child is immunocompromised, additional doses of Comirnaty LP.8.1 may be administered. In such cases, the child should continue to follow physical precautions to help prevent COVID-19. Where appropriate, close contacts of the child should also be vaccinated. Speak with your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty LP.8.1 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, refer to the package leaflet of the corresponding formulations.
The vaccine is not recommended in early infancy, in children under 6 months of age.

Other medicines and Comirnaty LP.8.1
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines, or if they have recently received any other vaccines.

Pregnancy and breastfeeding
Comirnaty LP.8.1 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, 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 engage in activities such as riding a bicycle. Your child should wait until these effects have subsided before resuming activities requiring full attention.

3. How Comirnaty LP.8.1 is administered

If the child is between 6 months and less than 12 months of age, they will receive Comirnaty LP.8.1 with a yellow cap after dilution as a 0.3 mL intramuscular injection in the thigh. In early childhood, or if the child is 1 year of age or older, they will receive Comirnaty LP.8.1 with a yellow cap after dilution as a 0.3 mL intramuscular injection 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 a COVID-19 vaccine, they should not receive a dose of Comirnaty LP.8.1 until at least 3 months have passed since their most recent dose.

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

If the child is immunocompromised, additional doses of Comirnaty LP.8.1 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 LP.8.1, consult the child’s paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 may cause side effects, although not everybody gets 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
• drowsiness (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)
• swollen 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 (‘common’ in children 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 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 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 LP.8.1

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 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.
If stored frozen between -90 °C and -60 °C, packs containing 10 vials of vaccine may be thawed and kept 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 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 the external carton with the expiry date for storage at 2 °C to 8 °C. Once thawed, 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 ambient light 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 the presence of 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 LP.8.1 Contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called mRNA encoding LP.8.1. After dilution, the vial with a yellow closure cap contains 3 doses of 0.3 mL each, with each dose containing 3 micrograms of mRNA encoding LP.8.1.
• 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 LP.8.1 and Contents of the Package
The vaccine is a dispersion (pH: 6.9–7.9), from clear to slightly opalescent.
It is supplied in a 2 mL multidose vial (Type I glass) with a rubber stopper and removable yellow plastic cap with an aluminum seal, containing 3 doses.
Pack of 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 on 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 LP.8.1 by intramuscular injection after dilution as a primary series of up to 3 doses (the total number of doses indicated 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 LP.8.1 by intramuscular injection after dilution as a single dose of 0.3 mL. If the individual has previously been vaccinated with an anti-COVID-19 vaccine, the dose of Comirnaty LP.8.1 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 LP.8.1 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 product name is Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion (infancy, children aged 6 months–4 years).
• If the vial has a different name on the label or if the cap has a different color, 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 to thaw. Thawing may take up to 2 hours for a pack of 10 vials. Ensure that vials are completely thawed before use.
• When transferring the product to storage at a temperature between 2 °C and 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, the closed vial 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 in the original vial with 1.1 mL of 9 mg/mL (0.9%) sodium chloride solution for injection, 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 and free from visible particles. If particles are present or if discoloration occurs, do not use the diluted vaccine.
• After dilution, clearly note 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 use.

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 swab.
• Withdraw 0.3 mL of Comirnaty LP.8.1 for infancy, children aged 6 months–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 remaining volume.
• Discard any unused vaccine within 12 hours of dilution.

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