Comirnaty Omicron XBB.1.5

Package leaflet: Information for the user

Comirnaty Omicron XBB.1.5 30 micrograms/dose concentrate for dispersion for injectable suspension

Adults and adolescents from 12 years of age
mRNA COVID-19 vaccine
raxtozinameran
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 all of this leaflet carefully before receiving this vaccine, as it contains important information for you.

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

Contents of this leaflet

1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before receiving Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injectable suspension is administered to adults and adolescents aged 12 years and older.
The vaccine prompts the immune system (the body's natural defences) to produce antibodies and active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 must not be given

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

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

• you have previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• 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 mild respiratory infection (such as a cold), you may still receive the vaccination;
• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may develop a few days after vaccination and have mostly occurred within 14 days. They have been observed more frequently after the second dose of vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay particular attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and contact your doctor immediately if these symptoms occur.
As with all vaccines, Comirnaty Omicron XBB.1.5 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty Omicron XBB.1.5 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty Omicron XBB.1.5. 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 Omicron XBB.1.5 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 Omicron XBB.1.5
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 Omicron XBB.1.5 can be given at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 can be given at the same time as a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 can be given at the same time as a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and older, Comirnaty Omicron XBB.1.5 can be given at the same time as a high-dose influenza vaccine and an RSV vaccine.

Pregnancy and breastfeeding
If you are pregnant or think you might be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine.
Data on the use of Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 may be used during pregnancy.
Data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in breastfed infants. Data from women who breastfed after receiving the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in infants. Comirnaty Omicron XBB.1.5 may be used during breastfeeding.

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

3. How Comirnaty Omicron XBB.1.5 is administered

Comirnaty Omicron XBB.1.5 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.
If you have already been vaccinated with a COVID‑19 vaccine, you should not receive a dose of
Comirnaty Omicron XBB.1.5 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of
Comirnaty Omicron XBB.1.5.
If you have any questions about the use of Comirnaty Omicron XBB.1.5, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 may cause side effects, although not everybody will experience them.

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

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

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

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

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

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

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

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

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

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

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

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

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

5. How to store Comirnaty Omicron XBB.1.5

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

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

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

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

Before use, unopened vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under 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 possible transport time of 6 hours. Discard any unused vaccine.

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

6. Package contents and other information

What Comirnaty Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called raxtozinameran.
  • A single-dose vial contains 1 dose of 0.3 mL, each containing 30 micrograms of raxtozinameran.
  • A multi-dose vial contains 6 doses of 0.3 mL, each containing 30 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in:

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

Pack of 10 single-dose vials.
Packs of 10 or 195 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

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

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The following information is intended exclusively for healthcare professionals:

Administer Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
should be administered at least 3 months after the most recent dose of any anti-COVID-19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered product must be clearly recorded.
Instructions for handling prior to use
Comirnaty Omicron XBB.1.5 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 clearly labeled as Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injectable preparation (adults and children aged ≥ 12 years).
• If the vial is labeled with a different name, refer to the summary of product characteristics for that specific 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 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, 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 vial 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.
• Determine whether the vial is a single-dose or multi-dose vial, and follow the applicable handling instructions below:
  • Single-dose vials
  • Withdraw a single 0.3 mL dose of vaccine.
  • Discard the vial and any remaining volume.
  • Multi-dose vials
  • Multi-dose vials contain 6 doses of 0.3 mL each.
  • Using aseptic techniques, clean the vial stopper with a single-use disinfectant swab.
  • Withdraw 0.3 mL of Comirnaty Omicron XBB.1.5.
  • To extract 6 doses from a single vial, low-dead-volume syringes and/or needles must be used. The syringe-needle combination must have a dead volume of no more than 35 microliters. When standard syringes and needles are used, the residual volume may be insufficient to withdraw a sixth dose from a single vial.
  • Each dose must contain 0.3 mL of vaccine.
  • If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any remaining volume.
  • Clearly label the vial with the date and time of first puncture. Discard any unused vaccine within 12 hours of first puncture.

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

Patient Information Leaflet: Information for the User

Comirnaty Omicron XBB.1.5 30 micrograms/dose injectable dispersion in pre-filled syringe (plastic)

For adults and adolescents aged 12 years and older
mRNA COVID-19 vaccine
raxtozinameran
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 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 effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before receiving Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 30 micrograms/dose, dispersion for injectable preparation, is administered to adults and adolescents 12 years of age 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 Omicron XBB.1.5 does not contain the virus to induce immunity, it cannot transmit COVID-19.
This vaccine should be used in accordance with official recommendations.

2. What you should know before receiving Comirnaty Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 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 tend to feel anxious about vaccination procedures or have fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or an upper respiratory tract infection (such as a cold), you may still be vaccinated;
• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system due to 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 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 Omicron XBB.1.5 may not fully protect all individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty Omicron XBB.1.5 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty Omicron XBB.1.5. 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 Omicron XBB.1.5 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 Omicron XBB.1.5
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, or if you have recently received any other vaccine.
Comirnaty Omicron XBB.1.5 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 may be administered simultaneously with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 may be administered simultaneously with a respiratory syncytial virus (RSV) vaccine.
In older adults, aged 65 years and older, Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 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 during pregnancy or on the newborn following vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty Omicron XBB.1.5 may be used during pregnancy.
Data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in breastfed infants. Data from women who breastfed after receiving the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in infants. Comirnaty Omicron XBB.1.5 may be used during breastfeeding.

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

3. How Comirnaty Omicron XBB.1.5 is given

Comirnaty Omicron XBB.1.5 is administered as a 0.3 mL intramuscular injection into the upper arm.
You will receive 1 injection, regardless of whether you have previously received a COVID‑19 vaccine.
If you have previously been vaccinated with a COVID‑19 vaccine, you should not receive a dose of
Comirnaty Omicron XBB.1.5 earlier than 3 months after your most recent dose.
If you are immunocompromised, you may be given additional doses of
Comirnaty Omicron XBB.1.5.
If you have any questions about the use of Comirnaty Omicron XBB.1.5, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 may cause side effects, although not everybody will experience 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

• feeling unwell, sensation 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 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 pricking sensations (paraesthesia)
• reduced sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-severe and transient in nature)

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

5. How to store Comirnaty Omicron XBB.1.5

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after “Exp.”. The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.
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 for 60 minutes at room temperature (not exceeding 30 °C).
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 storage at 2 °C to 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Comirnaty Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called raxtozinameran.
  • One pre-filled syringe contains 1 dose of 0.3 mL, containing 30 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 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 polyolefin cyclic copolymer plastic syringe) with a plunger stopper (synthetic bromobutyl rubber) and protective cap (synthetic bromobutyl rubber), without needle.
Pack of 10 pre-filled syringes:

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

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

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

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

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

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

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
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 Omicron XBB.1.5 must be prepared by a healthcare professional using aseptic
techniques to ensure the sterility of the prepared dispersion.
Instructions for prefilled syringes
Prefilled plastic syringes

• Prefilled plastic syringes supplied 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 a storage temperature between 2 °C and 8 °C, update the expiration date on the box. If the syringes are supplied at a temperature between 2 °C and 8 °C, verify that the expiration date has been updated.
• After thawing, prefilled syringes (previously frozen) may be stored at a temperature between 2 °C and 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 before use at temperatures between 8 °C and 30 °C and may be handled under normal lighting conditions.
• Remove the protective cap by slowly turning it counterclockwise. Do not shake. Attach a needle suitable for intramuscular injection and administer the entire volume.

Disposal
Any 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 Omicron XBB.1.5 30 micrograms/dose suspension for injection in

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

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

Contents of this leaflet

1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before receiving Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injectable suspension is administered to adults and adolescents aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 must not be given

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

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

• you have previously had a severe allergic reaction or breathing problems after an injection of another vaccine or after receiving this vaccine in the past;
• you tend to feel anxious or have fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or an upper respiratory tract infection (such as a cold), you may still receive the vaccination;
• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system due to 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 these symptoms occur.
As with all vaccines, Comirnaty Omicron XBB.1.5 may not fully protect all
individuals who receive it, and the duration of protection is not known.
The effectiveness of Comirnaty Omicron XBB.1.5 may be reduced in
immunocompromised individuals. If you are immunocompromised, you may be given additional
doses of Comirnaty Omicron XBB.1.5. 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 Omicron XBB.1.5 30 micrograms/dose, dispersion 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 Omicron XBB.1.5
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 Omicron XBB.1.5 may be administered at the same time as an influenza vaccine.
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 may be administered
concomitantly with a pneumococcal conjugate vaccine (PCV).
In adults aged 18 years and older, Comirnaty Omicron XBB.1.5 may be administered
concomitantly with a respiratory syncytial virus (RSV) vaccine.
In older adults aged 65 years and above, Comirnaty Omicron XBB.1.5 may be administered
concomitantly with a high-dose influenza vaccine and an RSV vaccine.
Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine.
Data on the use of Comirnaty Omicron XBB.1.5 in pregnant women are not yet
available. However, extensive 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 the pregnancy or the newborn. Although data on effects during
pregnancy or on the newborn after vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty
Omicron XBB.1.5 may be used during pregnancy.
Data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding are not yet
available. However, the vaccine is not expected to cause effects in breastfed infants. Data from
women who were breastfeeding after administration of the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in newborns/infants. Comirnaty Omicron XBB.1.5 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 vehicles or operate machinery. Wait until these
effects have subsided before driving or operating machinery.

3. How Comirnaty Omicron XBB.1.5 is administered

Comirnaty Omicron XBB.1.5 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 must not receive a dose of
Comirnaty Omicron XBB.1.5 within at least 3 months of your most recent dose.
If you are immunocompromised, you may be given additional doses of
Comirnaty Omicron XBB.1.5.
If you have any questions about the use of Comirnaty Omicron XBB.1.5, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 may cause side effects, although not everybody will experience 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 weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced appetite
• dizziness
• excessive sweating, night sweats

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

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

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

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

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

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may 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)
• reduced 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, tell 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 Omicron XBB.1.5

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.".
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 room light conditions.
Do not use this vaccine if you notice particles in the diluent 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 Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called raxtozinameran.
  • Each pre-filled syringe contains 1 dose of 0.3 mL, each containing 30 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a pre-filled syringe (Type I glass syringe) with a plunger stopper (synthetic bromobutyl rubber) and a protective cap (synthetic bromobutyl rubber), without a needle.
Pack of 10 pre-filled syringes.

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

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

For further information 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 Omicron XBB.1.5 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 Omicron XBB.1.5
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 traceability of biological medicinal products, the name and batch number of the
administered medicinal product must be clearly recorded.
Instructions for handling prior to use
Comirnaty Omicron XBB.1.5 must be prepared by a healthcare professional using aseptic techniques
to ensure sterility of the prepared dispersion.
Instructions for prefilled syringes
Prefilled glass syringes

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

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

Package leaflet: information for the user

Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for injectable dispersion

Children aged 5 to 11 years
mRNA COVID-19 vaccine
raxtozinameran
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 notice in the child while using 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 Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is given
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease
caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 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 defenses) to produce antibodies and
blood cells active against the virus, thereby providing protection against COVID-19.
Since Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 must not be administered

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

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

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

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 close
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 Omicron XBB.1.5 may not fully protect all individuals who receive it,
and the duration of protection is not known.
The effectiveness of Comirnaty Omicron XBB.1.5 may be reduced in immunocompromised individuals.
If the child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 may be given. In
such cases, the child should continue to follow physical precautions to help prevent COVID-19. If
appropriate, close contacts of the child should also be vaccinated. Talk to your paediatrician about the
recommendations most suitable for your child.
Children
Comirnaty Omicron XBB.1.5 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,
please refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.
Other medicines and Comirnaty Omicron XBB.1.5
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any
other medicines, or if they have recently received any other vaccines.
Pregnancy and breastfeeding
If the girl is pregnant, inform the paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty Omicron XBB.1.5 in pregnant women are not yet available. However, a
large amount of data from pregnant women vaccinated with the originally authorised 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 Omicron XBB.1.5 may be used during pregnancy.
Data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding are not yet available. However,
the vaccine is not considered likely to cause effects in newborns/infants. Data from women who were
breastfeeding after receiving the originally authorised Comirnaty vaccine have not shown any risk of
adverse effects in newborns/infants. Comirnaty Omicron XBB.1.5 may be used during breastfeeding.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily
affect the child's ability to use machines or to carry out activities such as riding a bicycle. The child
should wait until these effects have passed before resuming activities requiring full attention.

3. How Comirnaty Omicron XBB.1.5 is given

Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 until at least 3 months have passed since their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 may be administered.
If you have any questions about the use of Comirnaty Omicron XBB.1.5, consult the child's paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 may cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people

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

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

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

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

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

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

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

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

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

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

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

Reporting of side effects
If your child experiences any side 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 Omicron XBB.1.5

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine 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 vaccine 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 closed vial may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without ever exceeding the printed expiry date (Exp.).
Mark the external carton with the expiry date for storage at a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.
Prior to use, closed vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under normal lighting conditions.
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 Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called raxtozinameran. After dilution, each vial contains 10 doses of 0.2 mL, each dose containing 10 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 and contents of the pack
The vaccine is a white to almost white dispersion (pH: 6.9–7.9), supplied in a 10-dose multidose vial made of 2 mL clear type I glass, closed with a rubber stopper and an orange plastic flip-off cap sealed with an aluminium seal.
Pack size: 10 vials.

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

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

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

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, 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 Omicron XBB.1.5 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 Omicron XBB.1.5
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 prior to use
Comirnaty Omicron XBB.1.5 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 clearly labeled as Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injectable solution (for children aged 5–11 years).
• If the vial label displays a different name, refer to the summary of product characteristics for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C for thawing. Thawing a pack of 10 vials may take up to 4 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 kept 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 smaller) 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 mark the expiration date and time on the vial.
• After dilution, store at a temperature between 2 °C and 30 °C and use within 12 hours.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to reach room temperature before administration.

Preparation of 0.2 mL doses

• After dilution, the vial contains 2.6 mL, allowing for the extraction of 10 doses of 0.2 mL each.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
• Withdraw 0.2 mL of Comirnaty Omicron XBB.1.5 for children aged 5 to 11 years.
• To extract 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 extract 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 vaccine.
• Discard any unused vaccine within 12 hours of dilution.

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

Package leaflet: Information for the user

Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection

Children aged 5 to 11 years
Anti-COVID-19 mRNA vaccine
raxtozinameran
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 notice 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 Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Package contents and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease
caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 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 the vaccination procedure;
• 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 a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may develop within a few days after vaccination and have 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 Omicron XBB.1.5 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty Omicron XBB.1.5 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 may be administered. In such cases, your child should continue to maintain physical precautions to help prevent COVID-19. Where appropriate, close contacts of your child should also be vaccinated. Talk to your paediatrician about the most appropriate recommendations for your child.

Children
Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines, or if any other vaccines have recently been administered.

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 Omicron XBB.1.5 in pregnant women are not yet available. However, a large amount 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 during pregnancy or on the newborn following vaccination in the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty Omicron XBB.1.5 may be used during pregnancy.
Data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in infants. Data from women who were breastfeeding after administration of the originally authorised Comirnaty vaccine have not shown any risk of adverse effects in infants. Comirnaty Omicron XBB.1.5 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 child’s ability to use machinery or perform activities such as riding a bicycle. Your child should wait until these effects have subsided before resuming activities requiring full attention.

3. How Comirnaty Omicron XBB.1.5 is given

Comirnaty Omicron XBB.1.5 is given 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 Omicron XBB.1.5 until at least 3 months have passed since their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 may be administered.
If you have any questions about the use of Comirnaty Omicron XBB.1.5, consult the child's paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 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
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhea

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

Reporting of side effects
If the child experiences any side effects, including those not listed in this leaflet, please contact the 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 Omicron XBB.1.5

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 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 may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.

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

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

Before use, unopened vials may be kept at a temperature between 8 °C and 30 °C for up to 12 hours.
After thawing, vials may be handled under 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 possible transport time of 6 hours. Discard any unused vaccine.

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

6. Package contents and other information

What Comirnaty Omicron XBB.1.5 contains

• The active substance of the nucleoside-modified anti-COVID-19 mRNA vaccine is called raxtozinameran.
  • A single-dose vial contains 1 dose of 0.3 mL, with 10 micrograms of raxtozinameran per dose.
  • A multi-dose vial contains 6 doses of 0.3 mL each, with 10 micrograms of raxtozinameran per dose.
• The other components are:
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
  • 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
  • 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
  • cholesterol
  • tromethamine
  • tromethamine hydrochloride
  • sucrose
  • water for injections

Description of the appearance of Comirnaty Omicron XBB.1.5 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9), ranging from clear to slightly opalescent, supplied in:

• a single-dose vial containing 1 dose in a 2 mL transparent vial (type I glass) with a rubber stopper and a removable blue plastic cap sealed with an aluminium seal; or
• a multi-dose vial containing 6 doses in a 2 mL transparent vial (type I glass) with a rubber stopper and a removable blue plastic cap sealed 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 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 European Medicines Agency website: https://www.ema.europa.eu.

---

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
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 Omicron XBB.1.5 must be prepared by a healthcare professional using aseptic
techniques to ensure the sterility of the prepared dispersion.

• Check that the vial has a blue plastic cap and that the product name is Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injectable preparation (for children aged 5–11 years).
• If the vial label displays a different name, refer to the summary of product characteristics for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C for thawing. Ensure that vials are completely thawed before use.
  • Single-dose vials: up to 2 hours may be required to thaw a pack of 10 single-dose vials.
  • Multi-dose vials: up to 6 hours may be required to thaw a pack of 10 multi-dose vials.
• When transferring the product to storage at 2 °C to 8 °C, update the 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 kept for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Prior to mixing, the thawed dispersion may contain amorphous, opaque particles ranging in color from white to off-white.
• After mixing, the vaccine should appear as a dispersion from clear to slightly opalescent, free from visible particles. Do not use the vaccine if particles are present or if there is discoloration.
• 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 Omicron XBB.1.5 for children aged 5 to 11 years.
  • To extract 6 doses from a single vial, low dead-volume syringes and/or needles must be used. The syringe and needle combination must have a dead volume 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 ensure a complete 0.3 mL dose, discard the vial and any remaining volume.
  • Clearly mark the expiration date and time 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 requirements.

Package leaflet: information for the user

Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
mRNA COVID-19 vaccine
raxtozinameran
This medicine is under additional monitoring. This will allow any new safety information to be
rapidly identified. You can help by reporting any side effects you observe in the child while this
medicine is being administered. 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 Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion is administered to young children aged 6 months to 4 years.
The vaccine prompts the immune system (the body's natural defences) to produce antibodies and active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 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 anxious 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 can still be given;
• has a bleeding disorder, a tendency to bruise easily, or is taking medicines to prevent blood clots;
• has a weakened immune system due to an illness such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

After vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may occur a few days after vaccination and have mainly been observed within 14 days. They have occurred 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 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 Omicron XBB.1.5 may not fully protect everyone who receives it, and the duration of protection is not known.
It is possible that 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. Talk to your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
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
Comirnaty Omicron XBB.1.5 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 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 Omicron XBB.1.5 is administered

If the child is between 6 months and less than 12 months of age, they will receive Comirnaty Omicron XBB.1.5 with brown cap after dilution as an intramuscular injection of 0.2 mL in the thigh. In early childhood, or if the child is 1 year of age or older, they will receive Comirnaty Omicron XBB.1.5 with brown cap after dilution as an intramuscular injection of 0.2 mL in the thigh or upper arm.
If the child has not yet 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-19 vaccine, they should not receive a dose of Comirnaty Omicron XBB.1.5 until at least 3 months have passed since the most recent dose.
If the child turns 5 years old between doses during the primary series, they should complete the primary series by continuing to receive the 3 microgram dose.
If the child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5, please consult your paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 may cause side effects, although not everybody gets them.

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

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

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

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

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

• malaise, feeling 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 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 dermal filler injections)
• 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 sensation, such as tingling or prickling (paraesthesia)
• decreased sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient in nature)

Reporting of side effects
If 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 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 Omicron XBB.1.5

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine 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 vaccine 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 may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without ever exceeding the printed expiry date (Exp.).
Mark the 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.
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 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 Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside modified) is called raxtozinameran. After dilution, the vial with brown flip-off cap contains 10 doses of 0.2 mL, each containing 3 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 and contents of the pack
The vaccine is a white to almost white dispersion (pH: 6.9–7.9), supplied in a multidose vial containing 10 doses of 2 mL (Type I glass), with a rubber stopper and brown plastic flip-off cap sealed with aluminium.
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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

URL: www.comirnatyglobal.com
More detailed information on this medicinal product is available on the 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 Omicron XBB.1.5 with brown cap intramuscularly after dilution as a primary series of up to 3 doses (the total number of doses intended as 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 Omicron XBB.1.5 with brown cap intramuscularly after dilution as a single dose of 0.2 mL. If the individual has previously been vaccinated with an anti-COVID-19 vaccine, the dose of Comirnaty Omicron XBB.1.5 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.

Handling instructions prior to use

• Check that the vial has a brown plastic cap and that the product name is Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion (for infants and children aged 6 months to 4 years).
• If the vial has a different name on the label or if the cap has a different color, refer to the product characteristics summary for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C to thaw. It may take up to 2 hours to thaw a pack of 10 vials. Ensure that 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.
• Before 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 brown cap

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Before dilution, the thawed dispersion may contain amorphous, opaque particles, white to off-white in color.
• The thawed vaccine must be diluted in the original vial with 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, equalize 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. Do not use the diluted vaccine if particles are present or if discoloration occurs.
• After dilution, clearly mark the expiration date and time of the diluted dispersion on the vial.
• 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 use.

Preparation of 0.2 mL doses using a vial with brown 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 Omicron XBB.1.5 for infants and 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. If standard syringes and needles are used, 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 amount of vaccine remaining in the vial is insufficient to ensure a complete dose of 0.2 mL, 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 it must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion

Infants and children aged 6 months to 4 years
Anti-COVID-19 mRNA vaccine
raxtozinameran
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, ask your paediatrician, pharmacist, or nurse.
• If the child experiences any adverse reactions, including those not listed in this leaflet, consult your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is administered
4. Possible adverse reactions
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information

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

Comirnaty Omicron XBB.1.5 is a vaccine used to prevent COVID-19, a disease
caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion is
administered to young children aged 6 months to 4 years.
The vaccine prompts the immune system (the body's natural defences) to produce antibodies and
blood cells active against the virus, thereby providing protection against COVID-19.
Since Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 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 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 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 Omicron XBB.1.5 may not fully protect everyone who receives 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. Where appropriate, close contacts of your child should also be vaccinated. Speak with your paediatrician about recommendations suitable for your child.

Children
Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5
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
Comirnaty Omicron XBB.1.5 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 operate machinery or 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 Omicron XBB.1.5 is administered

If the child is aged between 6 months and less than 12 months, they will receive Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 with a yellow cap after dilution as a 0.3 mL intramuscular injection in the thigh or upper arm.

If the child has not yet 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 Omicron XBB.1.5 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 by continuing to receive the 3 microgram dose.

If the child is immunocompromised, additional doses of Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5, please consult your pediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Omicron XBB.1.5 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
• diarrhea

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

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

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

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

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

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, please contact the pediatrician, 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 Omicron XBB.1.5

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date stated on the carton and label after “Exp.”. The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine 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 vaccine 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 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.).
Record on the outer carton the expiry date for storage at a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.
Before use, unopened vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under normal lighting conditions.
After dilution, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum transport time of 6 hours. Discard any unused vaccine.
Do not use this vaccine if you notice particles in the diluted solution or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty Omicron XBB.1.5 contains

• The active substance of the anti-COVID-19 mRNA vaccine (nucleoside-modified) is called raxtozinameran. After dilution, the vial with yellow cap contains 3 doses of 0.3 mL each, each dose containing 3 micrograms of raxtozinameran.
• 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 Omicron XBB.1.5 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9) ranging 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 aluminum seal.
Pack size: 10 vials.
Marketing Authorization Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +49 6131 9084-0
Fax: +49 6131 9084-2121
[email protected]
Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 – 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

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

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The following information is intended exclusively for healthcare professionals:

If the child has not completed a primary series of anti-COVID-19 vaccination or does not have a history of prior SARS-CoV-2 infection, administer Comirnaty Omicron XBB.1.5 with yellow 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 Omicron XBB.1.5 with yellow cap intramuscularly after dilution as a single dose of 0.3 mL. If the individual has previously been vaccinated with an anti-COVID-19 vaccine, the dose of Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 must be prepared by a healthcare professional using aseptic techniques to ensure sterility of the prepared dispersion.

• Check that the vial has a yellow plastic cap and that the product name is Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for injectable dispersion (for early childhood, children aged 6 months to 4 years).
• If the vial has a different name on the label or if the cap has a different color, refer to the product characteristics summary for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C to thaw. Thawing may take up to 2 hours for a pack of 10 vials. Ensure vials are completely thawed before use.
• When transferring the product to storage at 2 °C to 8 °C, update the expiration date on the carton.
• Closed vials may be stored at 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.
• Before use, the closed vial may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Dilution of a vial with yellow cap

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Before dilution, the thawed dispersion may contain amorphous, opaque particles ranging in color from white to off-white.
• The thawed vaccine must be diluted within the original vial with 1.1 mL of 9 mg/mL (0.9%) sodium chloride injectable solution, using a 21-gauge (or finer) needle and aseptic techniques.
• 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 and free of visible particles. Do not use the diluted vaccine if particles are present or if there is discoloration.
• After dilution, clearly label the vials with the expiration date and time 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 use.

Preparation of 0.3 mL doses using a vial with yellow 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 wipe.
• Withdraw 0.3 mL of Comirnaty Omicron XBB.1.5 for early childhood, children aged 6 months to 4 years. To withdraw 3 doses from a single vial, standard syringes and/or needles may be used.
• Each dose must contain 0.3 mL of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete dose of 0.3 mL, discard the vial and any excess volume.
• Discard any unused vaccine within 12 hours after dilution.

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