Comirnaty JN.1

Package leaflet: Information for the user

Comirnaty JN.1 30 micrograms/dose concentrate for dispersion for injection (vials

frozen)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
bretovameran
This medicinal product is subject to additional monitoring. This will allow rapid identification of
new safety information. You can help by reporting any suspected adverse reactions you
experience while taking this medicine. See the end of section 4 for information on how to
report adverse reactions.
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 experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

2. What you need to know before receiving Comirnaty JN.1

3. How Comirnaty JN.1 is administered

4. Possible side effects

5. How to store Comirnaty JN.1

6. Contents of the pack and other information

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.1 30 micrograms/dose concentrate for dispersion for injection is administered to
adults and adolescents aged 12 years and older.
The vaccine works by training 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 JN.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 JN.1

Comirnaty JN.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 had a severe allergic reaction or breathing problems after an injection of another vaccine or after previously receiving this vaccine;
• vaccination 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.

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 a few days after vaccination and have mainly 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 seek immediate medical advice if these symptoms occur.
As with all vaccines, Comirnaty JN.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty JN.1. In these 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 JN.1 30 micrograms/dose suspension for injectable preparation 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 JN.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 JN.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty JN.1 may be administered simultaneously with a conjugated pneumococcal vaccine (PCV).
In adults aged 18 years and older, Comirnaty JN.1 may be administered simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty JN.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 JN.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 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 JN.1 can be used during pregnancy.
Data on the use of Comirnaty JN.1 during breastfeeding are not yet available. However, the vaccine is not considered 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 JN.1 can 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 operate machinery. Wait until these effects have subsided before driving or using machinery.

3. How Comirnaty JN.1 is administered

Comirnaty JN.1 is administered as an intramuscular injection of 0.3 mL into 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 JN.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 JN.1.
If you have any questions about the use of Comirnaty JN.1, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.1 can cause side effects, although not everybody gets them.

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

• at 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 or older and in immunocompromised individuals aged 12 to 18 years)
• redness at injection site (‘very common’ in immunocompromised individuals aged 12 years or 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 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 containing 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 lighter red rings (erythema multiforme)
• unusual skin sensation, such as tingling or prickling (paresthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-severe 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 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 JN.1

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.". 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 medicinal product from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine can 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 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 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 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, 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 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 JN.1 contains

• The active substance in the nucleoside-modified mRNA COVID-19 vaccine is called bretovameran.
  • A single-dose vial contains 1 dose of 0.3 mL, each dose containing 30 micrograms of bretovameran.
  • A multi-dose vial contains 6 doses of 0.3 mL, each dose containing 30 micrograms of bretovameran.
• 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 JN.1 and package contents
The vaccine is a white to almost white dispersion (pH: 6.9–7.9), supplied in:

• a single-dose vial of 1 dose in a 2 mL clear vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap with an aluminium seal, or
• a multi-dose vial of 6 doses in a 2 mL clear vial (Type I glass) with a rubber stopper and a grey plastic flip-off 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 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, 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 JN.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 JN.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
To improve traceability of biological medicinal products, the name and batch number of the
administered product must be clearly recorded.
Handling instructions prior to use of frozen vials
Comirnaty JN.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 JN.1 30 micrograms/dose dispersion for injectable preparation (adults and children aged ≥ 12 years).
• If the vial label shows 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 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 conditions 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.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Before 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.
• 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 wipe.
  • Withdraw 0.3 mL of Comirnaty JN.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 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 first puncture.

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

Patient Information Leaflet: Information for the User

Comirnaty JN.1 30 micrograms/dose dispersion for injectable preparation (refrigerated vials only)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
bretovameran
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any suspected adverse reactions you experience while receiving this medicine. See the end of section 4 for information on how to report adverse reactions.
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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

2. What you need to know before receiving Comirnaty JN.1

3. How Comirnaty JN.1 is administered

4. Possible side effects

5. How to store Comirnaty JN.1

6. Contents of the pack and other information

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.1 30 micrograms/dose dispersion for injectable preparation is administered to adults and adolescents aged 12 years and older.
The vaccine stimulates 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 JN.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 JN.1

Comirnaty JN.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 had a severe allergic reaction or breathing problems after an injection of another vaccine or after previously receiving this vaccine;

• the vaccination procedure 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 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 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 JN.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty JN.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 JN.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 JN.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 JN.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty JN.1 may be administered simultaneously with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty JN.1 may be administered simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty JN.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 JN.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 not shown any negative effects on pregnancy or the newborn. Although data on effects during pregnancy or on the newborn after vaccination in the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty JN.1 may be used during pregnancy.
Data on the use of Comirnaty JN.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 authorized Comirnaty vaccine have not shown any risk of adverse effects in breastfed infants. Comirnaty JN.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 or use machinery. Wait until these effects have subsided before driving or operating machinery.

3. How Comirnaty JN.1 is administered

Comirnaty JN.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 JN.1 earlier than 3 months after your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty JN.1.
If you have any questions about the use of Comirnaty JN.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.1 can 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 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

• 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 appear target-like or as “bull’s eye” lesions with a dark red centre 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 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, please inform 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 JN.1

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 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 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 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 JN.1 contains

• The active substance of the nucleoside-modified anti-COVID-19 mRNA vaccine is called bretovameran. A multidose vial contains 6 doses of 0.3 mL each, with each dose containing 30 micrograms of bretovameran.
• 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 JN.1 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a multidose vial containing 6 doses in a 2 mL transparent glass vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap sealed 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 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 JN.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 JN.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
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 JN.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 JN.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 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 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.
• Before mixing, the 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 visible 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 JN.1. 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 not exceeding 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 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 JN.1 30 micrograms/dose injectable dispersion in pre-filled syringe (plastic)
Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
bretovameran
This medicinal product is under 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 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.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 JN.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 JN.1

Comirnaty JN.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;
• 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 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 a few days after vaccination and have mainly
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 JN.1 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty
JN.1. In such cases, you should continue to take physical precautions to help prevent COVID-19. If appropriate, your close contacts should also be vaccinated. Talk
to your doctor about the recommendations most suitable for you.
Children
Comirnaty JN.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 JN.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 vaccines.
Comirnaty JN.1 may be given at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty JN.1 may be given at the same time as a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty JN.1 may be given at the same time as a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty JN.1 may be given at the same time as a high-dose influenza vaccine and an RSV vaccine.
Pregnancy and breastfeeding
If you are pregnant or suspect you might be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine.
Data on the use of Comirnaty JN.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 JN.1 may be used
during pregnancy.
Data on the use of Comirnaty JN.1 during breastfeeding are not yet available. However,
it is not considered likely that the vaccine would cause effects in newborns/infants. Data from women who were breastfeeding after receiving the originally authorized Comirnaty vaccine did not show any risk of adverse effects in newborns/infants. Comirnaty JN.1 may be used during
breastfeeding.
Driving and using machines
Some of the vaccine side effects mentioned in section 4 (Possible side effects) may
temporarily affect your ability to drive or use machines. Wait until these effects have subsided before driving or using machines.

3. How Comirnaty JN.1 is administered

Comirnaty JN.1 is given as an intramuscular injection of 0.3 mL into the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID‑19 vaccine or not.
If you have previously been vaccinated with a COVID‑19 vaccine, you should not receive a dose of Comirnaty JN.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 JN.1.
If you have any doubts about the use of Comirnaty JN.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.1 can cause side effects, although not everybody gets them.

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

• 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 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)
• decreased sensation, 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 ones 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 JN.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.". 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.
Frozen plastic pre-filled syringes: must be thawed before use. A pack of 10 pre-filled syringes can be thawed at a temperature between 2 °C and 8 °C. Thawing may take up to 2 hours. Before use, ensure that the pre-filled syringes are completely thawed.
Alternatively, a carton of 10 pre-filled syringes can be thawed at room temperature (not exceeding 30 °C) for 60 minutes.
If a single pre-filled syringe is thawed outside the carton at room temperature (not exceeding 30 °C), the pre-filled syringe must be used immediately.
Plastic pre-filled syringes (previously frozen), after thawing: once removed from the freezer, pre-filled syringes may be stored at a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.). When transferring the pre-filled syringes to a storage temperature between 2 °C and 8 °C, update the expiry date on the carton. If the syringes are supplied at a temperature between 2 °C and 8 °C, verify that the expiry date has been updated. Once thawed, the vaccine must not be refrozen.
Thawed pre-filled syringes may be kept for up to 12 hours before use at temperatures between 8 °C and 30 °C and may be handled under normal lighting conditions.
Do not use this vaccine if you notice the presence of particles 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 JN.1 contains

• The active substance of the nucleoside-modified anti-COVID-19 mRNA vaccine is called bretomeran.
  • One pre-filled syringe contains 1 dose of 0.3 mL, containing 30 micrograms of bretomeran.
• 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 JN.1 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 (1 mL plastic syringe made of cyclic olefin copolymer) with a plunger stopper (synthetic bromobutyl rubber) and protective cap (synthetic bromobutyl rubber), without needle.
Pack size: 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 JN.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 JN.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
medicinal product administered must be clearly recorded.
Instructions for handling prior to use
Comirnaty JN.1 must be prepared by a healthcare professional using aseptic techniques
to ensure sterility of the prepared dispersion.
Instructions for prefilled syringes
Prefilled plastic syringes

• Prefilled plastic syringes stored frozen must be completely thawed before use.
  • A pack of 10 prefilled syringes may be thawed at a temperature between 2 °C and 8 °C. Thawing may take up to 2 hours.
  • Alternatively, a box of 10 prefilled syringes may be thawed at room temperature (not exceeding 30 °C) for 60 minutes.
• If a single prefilled syringe is thawed outside the box at room temperature (not exceeding 30 °C), it must be used immediately.
• When transferring prefilled syringes to storage at 2 °C to 8 °C, update the expiration date on the box. If syringes are supplied at 2 °C to 8 °C, verify that the expiration date has been updated.
• After thawing, prefilled syringes (previously frozen) may be stored at 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.). Once thawed, the vaccine must not be refrozen.
• Thawed prefilled syringes may be kept for up to 12 hours prior to use at temperatures between 8 °C and 30 °C and may be handled under normal lighting conditions.
• Remove the protective cap by slowly rotating it counterclockwise. Do not shake. Attach a suitable needle for intramuscular injection and administer the entire volume.

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

Package leaflet: Information for the user

Comirnaty JN.1 30 micrograms/dose injectable dispersion for injection in pre-filled glass syringe

Adults and adolescents from 12 years of age
Anti-COVID-19 mRNA vaccine
bretovameran
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 JN.1 is and what it is used for
2. What you need to know before receiving Comirnaty JN.1
3. How Comirnaty JN.1 is administered
4. Possible side effects
5. How to store Comirnaty JN.1
6. Contents of the pack and other information

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.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 JN.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 JN.1

Comirnaty JN.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 ever 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 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 contact your doctor immediately if these symptoms occur.
As with all vaccines, Comirnaty JN.1 may not protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty JN.1. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. If appropriate, your close contacts should also be vaccinated. Talk to your doctor about the recommendations most suitable for you.

Children
Comirnaty JN.1 30 micrograms/dose suspension for injectable preparation 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 JN.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 JN.1 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty JN.1 may be administered at the same time as a conjugated pneumococcal vaccine (PCV).
In adults aged 18 years and older, Comirnaty JN.1 may be administered at the same time as a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty JN.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 suspect you may be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine.
Data on the use of Comirnaty JN.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 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 JN.1 may be used during pregnancy.
Data on the use of Comirnaty JN.1 during breastfeeding are not yet available. However, the vaccine is not considered likely 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 JN.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 JN.1 is administered

Comirnaty JN.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 JN.1 earlier than 3 months after your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty JN.1.
If you have any questions about the use of Comirnaty JN.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.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)
• swollen 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 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 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 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 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 JN.1

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.".
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty JN.1 contains

• The active substance of the nucleoside-modified anti-COVID-19 mRNA vaccine is called bretovameran.
  • Each pre-filled syringe contains 1 dose of 0.3 mL, each dose containing 30 micrograms of bretovameran.
• 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 JN.1 and contents of the pack
The vaccine is a white to almost 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 size: 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 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 obtain 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 JN.1 by intramuscular injection as a single 0.3 mL dose,
regardless of previous anti-COVID-19 vaccination status.
In individuals previously vaccinated with an anti-COVID-19 vaccine, Comirnaty JN.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 medicinal product must be clearly documented.
Instructions for handling prior to use
Comirnaty JN.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

• Before 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 twisting it counterclockwise. Do not shake. Attach a needle suitable for intramuscular injection, and administer the entire volume.

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

Package leaflet: information for the user

Comirnaty JN.1 10 micrograms/dose concentrate for injectable dispersion

Children aged 5 to 11 years
mRNA COVID-19 vaccine
bretovameran
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 taking 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, ask your paediatrician, pharmacist, or nurse.
• If the child experiences any side effects, including those not listed in this leaflet, consult your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.1 10 micrograms/dose concentrate for injectable dispersion 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 JN.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 JN.1

Comirnaty JN.1 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;
• becomes agitated or has fainted after an injection due to fear of needles;
• 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 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.

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 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 any of these symptoms occur.
As with all vaccines, Comirnaty JN.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty JN.1 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. Speak with your paediatrician about the most suitable recommendations for your child.

Children
Comirnaty JN.1 10 micrograms/dose concentrate for injectable dispersion 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 JN.1
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 your paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty JN.1 in pregnant women are not yet available. However, a large number of data from pregnant women vaccinated with the originally authorised Comirnaty vaccine during the second and third trimesters of pregnancy have not shown negative effects on pregnancy or the newborn. Although data on effects during pregnancy or on the newborn after vaccination in the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty JN.1 may be used during pregnancy.
Data on the use of Comirnaty JN.1 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in newborns/infants. Data from breastfeeding women after administration of the originally authorised Comirnaty vaccine have shown no risk of adverse effects in newborns/infants. Comirnaty JN.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 child’s ability to use machines 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 JN.1 is given

Comirnaty JN.1 is administered after dilution as a 0.2 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 JN.1 until at least 3 months have passed since their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty JN.1 may be administered.
If you have any questions about the use of Comirnaty JN.1, consult the child's paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.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

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)
• lymph node swelling (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 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 containing 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 lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-severe and transient in nature)

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult the paediatrician, pharmacist, or nurse. You may 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 JN.1

Keep this medicinal product 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 medicinal product after the expiration date stated on the carton and label after "Exp.". The expiration 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 medicinal product from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine can 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, the packs of 10 vials may be thawed at a temperature between 2 °C and 8 °C for up to 4 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 ever exceeding the printed expiration date (Exp.).
Mark the external carton with the expiration date for storage at a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.
Prior to 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 normal 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 observe the presence of particles in the diluted solution 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 JN.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside modified) is called bretomeran. After dilution, each vial contains 10 doses of 0.2 mL, each dose containing 10 micrograms of bretomeran.
• 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 JN.1 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a 10-dose multidose vial made of 2 mL clear glass (Type I) with a rubber stopper and an orange plastic flip-off cap sealed 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 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 : Pfizer Luxembourg SARL, Branch, Bulgaria, 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 JN.1 intramuscularly after dilution as a single 0.2 mL dose,
regardless of prior anti–COVID-19 vaccination status.
In individuals previously vaccinated with an anti–COVID-19 vaccine, Comirnaty JN.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
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 JN.1 must be prepared by a healthcare professional using aseptic techniques to
ensure sterility of the prepared dispersion.

• Check that the vial has an orange plastic cap and that the product name is Comirnaty JN.1 10 micrograms/dose concentrate for injectable dispersion (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 must be transferred to an environment at a temperature between 2 °C and 8 °C for thawing. Up to 4 hours may be required to thaw 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 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.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to 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 1.3 mL of 9 mg/mL (0.9%) sodium chloride injection solution, using a 21-gauge (or finer) needle and aseptic techniques.
• Before removing the needle from the vial stopper, equalize pressure in the vial by withdrawing 1.3 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 white to off-white dispersion, free from visible particles. If particles are present or if discoloration occurs, do not use the diluted vaccine.
• After dilution, clearly label the vials with the expiration date and time of the diluted dispersion.
• After dilution, store at 2 °C to 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 0.2 mL doses

• After dilution, the vial contains 2.6 mL, from which 10 doses of 0.2 mL can be withdrawn.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant swab.
• Withdraw 0.2 mL of Comirnaty JN.1 for children aged 5 to 11 years.
• To withdraw 10 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, the residual volume may not be sufficient to withdraw ten doses from a single vial.
• Each dose must contain 0.2 mL of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete 0.2 mL dose, discard the vial and any remaining volume.
• Discard any unused vaccine within 12 hours of dilution.

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 JN.1 10 micrograms/dose dispersion for injectable suspension

Children aged 5 to 11 years
Anti-COVID-19 mRNA vaccine
bretovameran
This medicinal product is under additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects observed in 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 your paediatrician, pharmacist, or nurse.
• If the child experiences any side effects, including those not listed in this leaflet, consult your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.1 10 micrograms/dose suspension for injection is administered to children aged 5 to 11 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 JN.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 JN.1

Comirnaty JN.1 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;
• becomes agitated or has fainted following an injection;
• has a serious illness or infection with high fever. However, if your child has a mild fever or an 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 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 a few days after vaccination and have mainly 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 seek immediate medical advice if any of these symptoms occur.
As with all vaccines, Comirnaty JN.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty JN.1 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty JN.1 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. Speak with your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty JN.1 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 JN.1
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 your daughter is pregnant, inform your paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty JN.1 in pregnant women are not yet available. However, a large number of data from 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 JN.1 can be used during pregnancy.
Data on the use of Comirnaty JN.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 infants. Comirnaty JN.1 can 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 child’s ability to operate 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 JN.1 is given

Comirnaty JN.1 is administered as a 0.3 mL intramuscular injection in 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 JN.1 earlier than 3 months after their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty JN.1 may be administered.
If you have any questions about the use of Comirnaty JN.1, consult the child's paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.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
• 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

• 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 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)
• reduced 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 effect, including those not listed in this leaflet, talk to 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 JN.1

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.". 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 medicinal product 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 and stored 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.

Multi-dose vials: If stored frozen at a temperature between -90 °C and -60 °C, packs of 10 multi-dose vials of vaccine 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.

Thawed vials (previously frozen): After removal from the freezer, the unopened vial may be stored and transported in a refrigerator 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. 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 normal 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 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 JN.1 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called bretomeran.
  • One single-dose vial contains 1 dose of 0.3 mL, containing 10 micrograms of bretomeran per dose.
  • One multidose vial contains 6 doses of 0.3 mL, each containing 10 micrograms of bretomeran 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-distearyl-sn-glycero-3-phosphocholine (DSPC)
  • cholesterol
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty JN.1 and package contents
The vaccine is a dispersion (pH: 6.9–7.9), ranging from clear to slightly opalescent, supplied in:

• a single-dose vial of 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 size: 10 single-dose vials.
Pack size: 10 multidose vials.
Not all pack sizes may be marketed.

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, 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 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 JN.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 JN.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 JN.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 JN.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 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 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 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.
• Before 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.
• 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 JN.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 combination of syringe and needle must have a dead volume not exceeding 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 first puncture.

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

Package leaflet: Information for the user

Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
mRNA COVID-19 vaccine
bretovameran
This medicinal product is subject to additional monitoring. This will allow for 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 reaction, including those not listed in this leaflet, contact your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion is administered to
children from 6 months to 4 years of age.
The vaccine prompts the immune system (the body's natural defences) to produce antibodies and
blood cells active against the virus, thereby providing protection against COVID-19.
Since Comirnaty JN.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 JN.1

Comirnaty JN.1 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 had a severe allergic reaction or breathing problems after an injection of another vaccine or after previously receiving this vaccine;
• becomes agitated or has fainted following an injection;
• has a serious illness or infection with high fever. However, if your child has a mild fever or an 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 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 occur a few days after vaccination and have mainly been observed within 14 days. They have been seen more often 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 advice if any of these symptoms occur.
As with all vaccines, Comirnaty JN.1 may not fully protect all individuals who receive it, and the duration of protection is unknown.
The effectiveness of Comirnaty may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty may be administered. In such cases, your child should continue to follow physical precautions to help prevent COVID-19. If appropriate, close contacts of your child should also be vaccinated. Speak with your paediatrician about the recommendations most suitable for your child.

Children

Comirnaty JN.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, please refer to the package leaflet of the corresponding formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty JN.1
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 JN.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, 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 operate 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 JN.1 is administered

If the child is aged 6 months to less than 12 months, they will receive Comirnaty JN.1 with brown cap after dilution as an intramuscular injection of 0.2 mL in the thigh. In early childhood or if the child is aged 1 year or older, they will receive Comirnaty JN.1 with brown cap after dilution as an intramuscular injection of 0.2 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 administered 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-19 vaccine, they should not receive a dose of Comirnaty JN.1 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 continuing to receive the 3-microgram dose.
If the child is immunocompromised, additional doses of Comirnaty JN.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 JN.1, consult the pediatrician, pharmacist, or nurse.

4. Possible side effects

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

• 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 children 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

• feeling unwell, feeling weak 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 center surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• decreased sensation, especially in the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient in nature)

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, talk 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 JN.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 can 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 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.
Vials (previously frozen), after thawing: once removed from the freezer, the closed vial can 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 a temperature between 2 °C and 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 possible 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 JN.1 contains

• The active substance of the nucleoside-modified anti-COVID-19 mRNA vaccine is called bretovameran. After dilution, the vial with brown flip-off cap contains 10 doses of 0.2 mL each, with each dose containing 3 micrograms of bretovameran.
• 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 JN.1 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a multidose vial containing 10 doses. The 2 mL transparent glass vial (Type I glass) is stoppered with a rubber stopper and sealed with a removable brown plastic cap and an aluminium seal.
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 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:

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 JN.1 with brown closure cap intramuscularly after dilution as a primary series of up to 3 doses (the total number of doses scheduled 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 JN.1 with brown closure cap intramuscularly after dilution as a single 0.2 mL dose. If the individual has previously been vaccinated with an anti-COVID-19 vaccine, the Comirnaty JN.1 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 JN.1 must be prepared by a healthcare professional using aseptic techniques to ensure sterility of the prepared dispersion.

• Verify that the vial has a brown plastic closure cap and that the product name is Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion (for early infancy, children aged 6 months to 4 years).
• If the vial label displays a different name or if the closure cap is 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 for thawing. Thawing of a 10-vial pack may take up to 2 hours. 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 of a vial with brown closure cap

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to 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 2.2 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, using a 21-gauge (or finer) needle and aseptic techniques.
• Before removing the needle from the vial stopper, stabilize pressure in the vial by withdrawing 2.2 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 white to off-white dispersion, free from visible particles. If particles are present or if discoloration occurs, do not use the diluted vaccine.
• After dilution, clearly label the vials with the date and time of expiration of the diluted dispersion.
• 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 0.2 mL doses using a vial with brown closure cap

• After dilution, the vial contains 2.6 mL, from which 10 doses of 0.2 mL can be withdrawn.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
• Withdraw 0.2 mL of Comirnaty JN.1 for early infancy, children aged 6 months to 4 years.
• To withdraw 10 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, the residual volume may not be sufficient to withdraw ten doses from a single vial.
• Each dose must contain 0.2 mL of vaccine.
• If the remaining volume in the vial is insufficient to ensure a complete dose of 0.2 mL, discard the vial and any excess volume.
• Discard any unused vaccine within 12 hours of dilution.

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

Package leaflet: Information for the user

Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
mRNA COVID-19 vaccine
bretovameran
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 you notice in the child while they are 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, ask your paediatrician, pharmacist, or nurse.
• If the child experiences any side effects, including those not listed in this leaflet, contact your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty JN.1 is a vaccine used to prevent COVID-19, a disease caused by
SARS-CoV-2.
Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion is administered to
children from 6 months to 4 years of age.
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 JN.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 JN.1

Comirnaty JN.1 must not be administered

• 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;
• becomes agitated or has fainted following an injection;
• has a serious illness or infection with high fever. However, if your 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 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 JN.1 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty may be given. In such cases, your child should continue to maintain physical precautions to help prevent COVID-19. If appropriate, close contacts of your child should also be vaccinated. Talk to your paediatrician about the recommendations best suited to your child.

Children
Comirnaty JN.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 other formulations.
The vaccine is not recommended in early infancy, in children under 6 months of age.

Other medicines and Comirnaty JN.1
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 JN.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 effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child’s ability to use machinery or to engage in activities such as riding a bicycle. Your child should wait until these effects have passed before resuming activities requiring full attention.

3. How Comirnaty JN.1 is administered

If the child is aged 6 months to less than 12 months, they will receive Comirnaty JN.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 aged 1 year or older, they will receive Comirnaty JN.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 an anti-COVID vaccine, they should not receive a dose of Comirnaty JN.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 complete the primary series continuing to receive the 3 microgram dose.

If the child is immunocompromised, additional doses of Comirnaty JN.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 JN.1, consult your pediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty JN.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
• 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)
• 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 (‘common’ in individuals aged 6 months to less than 2 years) or itching
• reduced appetite (‘very common’ in individuals 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 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 prickling (paraesthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient in nature)

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, talk to 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 JN.1

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 expiration date stated on the carton and label after "Exp.". The expiration 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 is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine can 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 a temperature between 2 °C and 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 ever exceeding the printed expiration date (Exp.).
Mark the external carton with the expiration date for storage at a temperature between 2 °C and 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 JN.1 contains

• The active substance in the nucleoside-modified mRNA COVID-19 vaccine is called bretovameran. After dilution, the vial with yellow cap contains 3 doses of 0.3 mL each, each dose containing 3 micrograms of bretovameran.
• 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 JN.1 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9), from clear to slightly opalescent, supplied in a multidose vial containing 3 doses in a 2 mL transparent vial (type I glass) with a rubber stopper and removable yellow plastic cap with an aluminium seal.
Pack size: 10 vials.
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), 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:

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 JN.1 with yellow closure cap by intramuscular injection after dilution as a primary series of up to 3 doses (the total number of doses scheduled 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 JN.1 with yellow closure cap by intramuscular injection after dilution as a single 0.3 mL dose. If the individual has previously received an anti-COVID-19 vaccine, the Comirnaty JN.1 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 documented.

Instructions for handling prior to use
Comirnaty JN.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 closure cap and that the product name is Comirnaty JN.1 3 micrograms/dose concentrate for injectable dispersion (early infancy, children aged 6 months to 4 years).
• If the vial label displays a different name or if the closure cap is 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 a refrigerator at a temperature between 2 °C and 8 °C for thawing. 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 accordingly.
• 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 kept for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Dilution of a vial with yellow closure cap

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to 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 injectable solution , using a 21-gauge (or finer) needle and aseptic techniques.
• Before removing the needle from the vial stopper, equalize pressure in the vial 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 particles are present or if discoloration occurs.
• After dilution, clearly label the vials with the date and time of expiration of the diluted dispersion.
• After dilution , store at 2 °C to 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 using a vial with yellow closure cap

• 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 JN.1 for early infancy, 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 remaining volume.
• Discard any unused vaccine within 12 hours of dilution.

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