Comirnaty Original/Omicron BA.4-5

Patient Information Leaflet: Information for the User

Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose suspension for injection

For adults and adolescents aged 12 years and older
COVID-19 mRNA vaccine
tozinameran/famtozinameran
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 effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

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

2. What you should know before receiving Comirnaty Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 must not be administered

• 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 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 within a few days after vaccination and have
mostly occurred within 14 days. They have been observed more frequently after the second
dose of the vaccine and in younger males. The risk of myocarditis and pericarditis appears
to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most
cases of myocarditis and pericarditis resolve. Some cases have required intensive care support, and fatal cases have been reported. After vaccination, pay particular attention to signs of
myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek
immediate medical attention if these symptoms occur.
As with all vaccines, Comirnaty Original/Omicron BA.4-5 may not fully protect everyone who
receives it, and the duration of protection is not known.
The effectiveness of Comirnaty Original/Omicron BA.4-5 may be reduced in immunocompromised
individuals. If you are immunocompromised, you may be given additional doses of Comirnaty
Original/Omicron BA.4-5. 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 Original/Omicron BA.4-5 (15/15 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 Original/Omicron BA.4-5
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 Original/Omicron BA.4-5 may be administered at the same time as an influenza 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 Original/Omicron BA.4-5 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 authorized 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 Original/Omicron BA.4-5 may be used during pregnancy.
Data on the use of Comirnaty Original/Omicron BA.4-5 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 administration of the originally authorized Comirnaty vaccine have not
shown any risk of adverse effects in newborns/infants. Comirnaty Original/Omicron BA.4-5 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 subsided before driving
or operating machinery.

3. How Comirnaty Original/Omicron BA.4-5 is administered

Comirnaty Original/Omicron BA.4-5 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 or not.
If you have already been vaccinated with a COVID-19 vaccine, you should not receive a dose of Comirnaty Original/Omicron BA.4-5 until at least 3 months have passed since your most recent dose.
If you are immunocompromised, you may be given additional doses of Comirnaty Original/Omicron BA.4-5.
If you have any questions about the use of Comirnaty Original/Omicron BA.4-5, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 may cause side effects, although not
everyone will experience them.
Very common side effects: may affect more than 1 in 10 people

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

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

• redness at the injection site
• nausea, vomiting
• enlarged 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 (Bell's palsy)
• allergic reactions such as hives or facial swelling

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

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

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

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections containing dermal fillers)
• skin reaction causing red spots or patches on the skin, which may appear target-shaped or like a "bull's eye", with a dark red centre surrounded by lighter red rings (erythema multiforme)
• unusual sensations on the skin, such as tingling or prickling (paraesthesia)
• reduced 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, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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.

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 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 between -90 °C and -60 °C, packs of 10 vials of vaccine 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 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.

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

Opened vials: After first puncture, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum 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 required. This will help protect the environment.

6. Package contents and other information

What Comirnaty Original/Omicron BA.4-5 contains

• The active substances of the anti-COVID-19 mRNA vaccine (nucleoside-modified) are called tozinameran and famtozinameran.
  • A single-dose vial contains 1 dose of 0.3 mL, containing 15 micrograms of tozinameran (Original) and 15 micrograms of famtozinameran (Omicron BA.4-5) per dose.
  • A multidose vial contains 6 doses of 0.3 mL, each containing 15 micrograms of tozinameran (Original) and 15 micrograms of famtozinameran (Omicron BA.4-5) 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 Original/Omicron BA.4-5 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 transparent vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap with an aluminium seal; or
• a multidose vial containing 6 doses in a 2 mL transparent vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap with an aluminium seal.

Pack of 10 single-dose vials.
Packs of 10 or 195 multidose vials.
Not all pack sizes may be marketed.

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

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

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

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

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

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

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty Original/Omicron BA.4-5 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 Original/Omicron BA.4-5 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 documented.

Instructions for handling prior to use

Comirnaty Original/Omicron BA.4-5 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 Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injectable preparation (for adults and children aged ≥ 12 years).
• If the vial label displays 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 refrigerator 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 conditions between 2 °C and 8 °C, update the expiration date on the carton accordingly.
• Closed vials may be stored at 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be kept for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under normal lighting conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Before mixing, the thawed dispersion may contain amorphous, opaque particles ranging in color from white to off-white.
• After mixing, the vaccine should appear as a white to off-white dispersion, free from visible particles. Do not use the vaccine if particles are present or if discoloration occurs.
• Determine whether the vial is a single-dose or multi-dose vial, and follow the appropriate 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 Original/Omicron BA.4-5. To obtain 6 doses from a single vial, precision syringes and/or needles (low dead volume) must be used. The combined syringe and needle must have a dead volume of no more than 35 microliters. When using standard syringes and needles, 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 vaccine.
• 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 material derived from this medicinal product must be disposed of in accordance with local regulations.

Package leaflet: information for the user

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injectable suspension

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

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

Contents of this leaflet

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

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

Comirnaty Original/Omicron BA.4-5 is a vaccine used to prevent COVID-19,
a disease caused by SARS-CoV-2. It 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 Original/Omicron BA.4-5 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 Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 must not be given

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

Warnings and precautions
Talk to your 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 anxious or faints in connection with injections;

• 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 mostly occurred within 14 days. They have been observed more frequently after the second dose of the vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve. Some cases have required intensive care support, and fatal cases have been reported. After vaccination, pay particular attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek immediate medical attention if these symptoms occur.
As with all vaccines, Comirnaty Original/Omicron BA.4-5 may not fully protect everyone who receives it, and the duration of protection is unknown.
The effectiveness of Comirnaty Original/Omicron BA.4-5 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty Original/Omicron BA.4-5 may be administered. In such cases, your child should continue to follow physical precautions to help prevent COVID-19. Where appropriate, close contacts of the child should also be vaccinated. Talk to your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for injectable dispersion is not recommended for children under 5 years of age.
Paediatric formulations are available for infants and children aged 6 months to 4 years. For details, refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty Original/Omicron BA.4-5
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
If the girl is pregnant, inform your paediatrician, nurse, or pharmacist before she receives this vaccine.
Data on the use of Comirnaty Original/Omicron BA.4-5 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 authorized Comirnaty vaccine have shown no negative effects on pregnancy or the newborn. Although data on effects on pregnancy or the newborn after vaccination during the first trimester are limited, no increased risk of miscarriage has been observed. Comirnaty Original/Omicron BA.4-5 may be used during pregnancy.
Data on the use of Comirnaty Original/Omicron BA.4-5 during breastfeeding are not yet available. However, the vaccine is not expected to cause effects in newborns/infants. Data from women who were breastfeeding after receiving the originally authorized Comirnaty vaccine have shown no risk of adverse effects in newborns/infants. Comirnaty Original/Omicron BA.4-5 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 machinery or engage in activities such as riding a bicycle. The child should wait until these effects have subsided before resuming activities requiring full attention.

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

Comirnaty Original/Omicron BA.4-5 is administered after dilution as an intramuscular injection of 0.2 mL 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 Original/Omicron BA.4-5 earlier than 3 months after their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty Original/Omicron BA.4-5 may be administered.
If you have any questions about the use of Comirnaty Original/Omicron BA.4-5, consult the child's paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 may cause side effects, although not all people 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

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

• nausea, vomiting
• redness at the injection site (‘very common’ in the age group 5 to 11 years)
• swollen lymph nodes (observed more frequently after a booster dose)

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

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

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

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

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

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

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

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may look like a target or “bull’s eye” with a dark red centre surrounded by lighter red rings (erythema multiforme)
• unusual sensations on the skin, such as tingling or pricking (paraesthesia)
• 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 effects, including those not listed in this leaflet, talk to your paediatrician, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

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

Keep this medicinal product out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicinal product after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store frozen at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicinal product from light.
The vaccine will be supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine can be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.
If stored frozen between -90 °C and -60 °C, packs of 10 vials may be thawed at a temperature between 2 °C and 8 °C for up to 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 new expiry date for storage between 2 °C and 8 °C on the outer carton. Once thawed, the vaccine must not be refrozen.
Before use, closed vials may be stored 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 any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty Original/Omicron BA.4-5 contains

• The active substances of the anti-COVID-19 mRNA vaccine (nucleoside-modified) are called tozinameran and famtozinameran. After dilution, each vial contains 10 doses of 0.2 mL, each dose containing 5 micrograms of tozinameran (Original) and 5 micrograms of famtozinameran (Original/Omicron BA.4-5).
• 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 Original/Omicron BA.4-5 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a multidose vial containing 10 doses, in a 2 mL transparent vial (Type I glass) with a rubber stopper and an orange plastic flip-off cap sealed with an aluminium seal.
Pack sizes: 10 or 195 vials.
Not all pack sizes may be marketed.

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

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

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

• België/Belgique/Belgien, Luxembourg/Luxemburg : Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България : Пфайзер Люксембург САРЛ, Клон, България, 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
• United Kingdom (Northern Ireland) : Pfizer Limited, Tel: +44 (0) 1304 616161

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 Original/Omicron BA.4‑5 by intramuscular injection 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
Original/Omicron BA.4‑5 should be administered at least 3 months after the most recent dose of anti‑COVID‑19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.

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

Instructions for handling prior to use
Comirnaty Original/Omicron BA.4-5 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 Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for injectable dispersion (for children aged 5–11 years).
• If the vial is labelled with 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 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 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain amorphous, opaque particles, white to off-white in color.
• The thawed vaccine must be diluted in the original vial with 1.3 mL of 9 mg/mL (0.9%) sodium chloride injection solution, using a 21-gauge (or finer) needle and aseptic techniques.
• Equalize pressure in the vial before removing the needle from the stopper 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. Do not use the diluted vaccine if particulate matter is present or if discoloration occurs.
• After dilution, clearly label the vials with the expiration date and time of the diluted dispersion.
• After dilution, store at 2 °C to 30 °C and use within 12 hours.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to reach room temperature before administration.

Preparation of 0.2 mL doses

• After dilution, the vial contains 2.6 mL, allowing for the extraction of 10 doses of 0.2 mL.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
• Withdraw 0.2 mL of Comirnaty Original/Omicron BA.4-5 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 and 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 excess volume.
• Discard any unused vaccine within 12 hours of dilution.

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

Patient Information Leaflet: Information for the User

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injectable suspension

For children aged 5 to 11 years
Anti-COVID-19 mRNA vaccine
tozinameran/famtozinameran
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you observe in the child while receiving this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before the child receives this vaccine, as it contains important information for you.

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

Contents of this leaflet

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

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

Comirnaty Original/Omicron BA.4-5 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2. It 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 Original/Omicron BA.4-5 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 Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 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 needles;

• has a serious illness or infection with high fever. However, if your child has a mild fever or a mild upper respiratory tract infection (such as a cold), vaccination may still proceed;

• has a bleeding disorder, a tendency to bruise easily, or is taking medicines to prevent blood clots;

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

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

Children
Comirnaty Original/Omicron BA.4-5 (5/5 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 Original/Omicron BA.4-5
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
If pregnancy occurs, inform your paediatrician, nurse, or pharmacist before your child receives this vaccine.
Data on the use of Comirnaty Original/Omicron BA.4-5 in pregnant women are not yet available. However, a large number of data from women vaccinated during the second and third trimesters of pregnancy with the originally authorized Comirnaty vaccine have not shown any negative effects on pregnancy or the newborn. Although data on effects on pregnancy or the newborn following vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty Original/Omicron BA.4-5 may be used during pregnancy.
Data on the use of Comirnaty Original/Omicron BA.4-5 during breastfeeding are not yet available. However, the vaccine is not considered likely to cause effects in breastfed infants. Data from women who were breastfeeding after receiving the originally authorized Comirnaty vaccine have not shown any risk of adverse effects in breastfed infants. Comirnaty Original/Omicron BA.4-5 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 passed before resuming activities requiring full attention.

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

Comirnaty Original/Omicron BA.4-5 is administered as an intramuscular injection of 0.3 mL into the upper arm of the child.
The child will receive 1 injection, regardless of whether they have previously received a COVID-19 vaccine.
If the child has previously been vaccinated with a COVID-19 vaccine, they should not receive a dose of Comirnaty Original/Omicron BA.4-5 until at least 3 months have passed since their most recent dose.
If the child is immunocompromised, additional doses of Comirnaty Original/Omicron BA.4-5 may be administered.
If you have any questions about the use of Comirnaty Original/Omicron BA.4-5, please consult the paediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people

• 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
• redness at the injection site (‘very common’ in the age group 5 to 11 years)
• 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
• 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 (paresthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-severe and transient in nature)

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, please contact 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 Original/Omicron BA.4-5

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 frozen at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine can be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.

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

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

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

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

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

Do not use this vaccine if you notice the presence of particles in the dilution 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 Original/Omicron BA.4-5 contains

• The active substances in the anti-COVID-19 mRNA vaccine (nucleoside-modified) are called tozinameran and famtozinameran.
  • One single-dose vial contains 1 dose of 0.3 mL, containing 5 micrograms of tozinameran (Original) and 5 micrograms of famtozinameran (Omicron BA.4-5) per dose.
  • One multidose vial contains 6 doses of 0.3 mL, each containing 5 micrograms of tozinameran (Original) and 5 micrograms of famtozinameran (Omicron BA.4-5) per dose.
• The other components are:
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldodecanoate) (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 Original/Omicron BA.4-5 and contents of the pack
The vaccine is a dispersion (pH: 6.9–7.9), from clear to slightly opalescent, supplied in:

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

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

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

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

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

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

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

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

---

The following information is intended exclusively for healthcare professionals:

Administer Comirnaty Original/Omicron BA.4-5 by intramuscular injection as a single 0.3 mL dose, regardless of prior COVID-19 vaccination status.
In individuals previously vaccinated with a COVID-19 vaccine, Comirnaty Original/Omicron BA.4-5 should be administered at least 3 months after the most recent dose of any COVID-19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.

Traceability
To improve 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 Original/Omicron BA.4-5 must be prepared by a healthcare professional using aseptic techniques to ensure sterility of the prepared dispersion.

• Verify that the vial has a blue plastic cap and that the product name is Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injectable preparation (for children aged 5–11 years).
• If the vial is labelled 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 stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.
• Prior to mixing, the thawed dispersion may contain amorphous, opaque particles ranging in color from white to off-white.
• After mixing, the vaccine should appear as a dispersion ranging from clear to slightly opalescent and free from visible particles. Do not use the vaccine if particulate matter is 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 Original/Omicron BA.4-5 for children aged 5 to 11 years. To extract 6 doses from a single vial, precision syringes and/or needles (low dead volume) must be used. The syringe and needle combination must have a dead volume of no more than 35 microliters. When standard syringes and needles are used, the residual volume may not be sufficient to withdraw a sixth dose from a single vial.
• Each dose must contain 0.3 mL of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any remaining volume.
• Clearly record the date and time of expiration on the vial. Discard any unused vaccine within 12 hours of the first puncture.

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

Package leaflet: information for the user

Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection

Infants and children aged 6 months to 4 years
mRNA-based COVID-19 vaccine
tozinameran/famtozinameran
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any suspected adverse reactions experienced by the child while receiving this medicinal product. 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, contact your paediatrician, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty Original/Omicron BA.4‑5 is a vaccine used to prevent COVID-19,
a disease caused by SARS-CoV-2. It is administered to young children aged
between 6 months and 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 Original/Omicron BA.4‑5 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 Original/Omicron BA.4‑5

Comirnaty Original/Omicron BA.4‑5 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 having received this vaccine in the past;

• becomes anxious or has fainted after 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 a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

Following vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see section 4). These conditions may occur within a few days after vaccination and have mostly been observed within 14 days. They have been seen 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 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 Original/Omicron BA.4‑5 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty Original/Omicron BA.4‑5 may be reduced in immunocompromised individuals. If your child is immunocompromised, additional doses of Comirnaty Original/Omicron BA.4‑5 may be administered. In such cases, your child should continue to follow physical precautions to help prevent COVID-19. Where appropriate, close contacts of your child should also be vaccinated. Speak with your paediatrician about the recommendations most suitable for your child.

Children
Comirnaty Original/Omicron BA.4‑5 (1.5/1.5 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 Original/Omicron BA.4‑5
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 vaccine.

Pregnancy and breastfeeding
Comirnaty Original/Omicron BA.4‑5 (1.5/1.5 micrograms)/dose concentrate for injectable dispersion is not intended for individuals over 5 years of age.
For details on use in individuals over 5 years of age, refer to the package leaflet of the corresponding formulations.

Driving and using machines
Some of the side effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child’s ability to use machines 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 Original/Omicron BA.4-5 is administered

If the child is between 6 months and less than 12 months of age, they will receive Comirnaty Original/Omicron BA.4-5, after dilution, as a 0.2 mL intramuscular injection in the thigh. In early childhood or if the child is 1 year of age or older, they will receive Comirnaty Original/Omicron BA.4-5, after dilution, as a 0.2 mL intramuscular injection in the thigh or in the upper arm.

If the child has not completed a primary series of anti-COVID-19 vaccination or has not previously had a COVID-19 infection, they will receive up to 3 injections (the total number of doses intended 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 was previously vaccinated with a COVID-19 vaccine, they should not receive a dose of Comirnaty Original/Omicron BA.4-5 earlier than 3 months after 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 Original/Omicron BA.4-5 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 intended as the primary series. The primary series should be administered only once.

If you have any questions about the use of Comirnaty Original/Omicron BA.4-5, consult your pediatrician, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 may cause side effects, although not everyone experiences them.

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

• irritability (in individuals aged 6 months to less than 2 years)
• at the injection site: pain/tenderness, swelling
• fatigue, headache
• sleepiness (in individuals 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
• redness at the injection site ('very common' in individuals aged 6 months to 11 years)
• enlarged lymph nodes (observed more frequently after a booster dose)

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

• malaise, feeling of weakness or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash ('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 determined 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 (paraesthesia)
• decreased sensitivity, especially of the skin (hypoesthesia)
• heavy menstrual flow (most cases were non-severe and transient in nature)

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, please contact the paediatrician, pharmacist, or nurse. You may 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 Original/Omicron BA.4-5

Keep this medicinal product out of the sight and reach of children.
The following information regarding storage, expiry, use, and handling is intended for healthcare professionals.
Do not use this medicinal product after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in a freezer at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicinal product from light.
The vaccine is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.
If stored frozen between -90 °C and -60 °C, the packs of 10 vials may be thawed at a temperature between 2 °C and 8 °C for up to 2 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.
Vials (previously frozen), after thawing: once removed from the freezer, the closed vial may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without 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. After thawing, the vaccine must not be refrozen.
Before use, closed vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under normal 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 Original/Omicron BA.4-5 contains

• The active substances in the nucleoside-modified mRNA COVID-19 vaccine are called tozinameran and famtozinameran. After dilution, each vial contains 10 doses of 0.2 mL, each dose containing 1.5 micrograms of tozinameran (Original) and 1.5 micrograms of famtozinameran (Omicron BA.4-5).
• 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 Original/Omicron BA.4-5 and package contents
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a multidose vial containing 10 doses, in a 2 mL transparent vial (Type I glass) with a rubber stopper and a brown 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, 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
• United Kingdom (Northern Ireland): Pfizer Limited, Tel: +44 (0) 1304 616161

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

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

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The following information is intended exclusively for healthcare professionals:

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 Original/Omicron BA.4-5 by intramuscular injection after dilution as a primary series of up to 3 doses (the total number of doses scheduled for the primary series) (0.2 mL each); 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 Original/Omicron BA.4-5 by intramuscular injection 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 Original/Omicron BA.4-5 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 recorded.

Instructions for handling prior to use

• Verify that the vial has a brown plastic cap and that the product name is Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for injectable dispersion (for infants and children aged 6 months to 4 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. Up to 2 hours may be required 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 a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiration date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, the closed vial may be stored for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain amorphous, opaque particles, white to off-white in color.
• The thawed vaccine must be diluted in the original vial with 2.2 mL of 9 mg/mL (0.9%) sodium chloride injectable solution , using a 21-gauge (or finer) needle and employing aseptic techniques.
• Stabilize pressure in the vial before removing the needle from the vial stopper by withdrawing 2.2 mL of air into the empty solvent syringe.
• Gently invert the diluted dispersion 10 times. Do not shake.
• The diluted vaccine should appear as a white to off-white dispersion, free from visible particles. If particles are present or if discoloration occurs, do not use the diluted vaccine.
• After dilution, clearly record the date and time of expiration 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, from which 10 doses of 0.2 mL can be extracted.
• Using aseptic techniques, clean the vial stopper with a single-use disinfectant wipe.
• Withdraw 0.2 mL of Comirnaty Original/Omicron BA.4-5 for infants and children aged 6 months to 4 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 be insufficient 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 volume.
• Discard any unused vaccine within 12 hours of dilution.

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