COMIRNATY OMICRON XBB.1.5 (10 micrograms/dose) Injectable Dispersion

Introduction

Package Leaflet: Information for the User

Comirnaty Omicron XBB.1.5 10 micrograms/dose injectable suspension

Children from 5 to 11 years of age

COVID-19 mRNA vaccine

tozinameran

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects your child may experience. The last section of section 4 will include information on how to report side effects.

Read all of this leaflet carefully before your child is given this vaccine because it contains important information for your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your child's doctor, pharmacist, or nurse.
• If your child experiences any side effects, talk to your child's doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child starts using Comirnaty Omicron XBB.1.5
3. How to use Comirnaty Omicron XBB.1.5
4. Possible side effects
5. Storage of 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 caused by SARS-CoV-2.

Comirnaty Omicron XBB.1.5 10 micrograms/dose injectable suspension is given to children from 5 to 11 years of age.

The vaccine makes the immune system (the body's natural defenses) produce antibodies and blood cells that fight the virus, providing protection against COVID-19.

Because Comirnaty Omicron XBB.1.5 does not contain the virus to produce immunity, it cannot give your child COVID-19.

This vaccine should be used in accordance with official recommendations.

2. What you need to know before your child starts using 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 child's doctor, pharmacist, or nurse before your child is given the vaccine if your child:

• has ever had a severe allergic reaction or breathing problems after being given any other vaccine or after being given this vaccine in the past;
• is nervous about the vaccination process or has fainted after an injection with a needle;
• has a severe illness or infection with high fever. However, your child can be vaccinated if they have a mild fever or an upper respiratory tract infection such as a cold;
• has a bleeding problem, bruises easily, or is taking a medicine to prevent blood clots;
• has a weakened immune system due to a disease such as HIV or due to a medicine, such as corticosteroids, that affects the immune system.

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) after vaccination with Comirnaty (see section 4). These conditions can occur within a few days of vaccination and have mainly occurred within 14 days. They have been observed more frequently after the second dose of vaccination and more frequently in young males. The risk of myocarditis and pericarditis appears to be lower in children from 5 to 11 years of age than in those aged 12 to 17 years. Most cases of myocarditis and pericarditis have recovered. Some cases required intensive care support and fatal cases have been observed. After vaccination, you should be alert to the signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and seek immediate medical attention if they occur.

As with any vaccine, Comirnaty Omicron XBB.1.5 may not completely protect all people who receive it and it is not known how long your child will be protected.

The effectiveness of Comirnaty Omicron XBB.1.5 may be lower in people with weakened immune systems. If your child is immunocompromised, they may receive additional doses of Comirnaty Omicron XBB.1.5. In these cases, your child should continue to maintain physical precautions to help prevent COVID-19. Additionally, your child's close contacts should be vaccinated as appropriate. Discuss individual recommendations with your child's doctor.

Children

Comirnaty Omicron XBB.1.5 10 micrograms/dose injectable suspension must not be used in children under 5 years of age.

Pediatric formulations are available for infants and children from 6 months to 4 years of age. For more information, see the package leaflet of other formulations.

The vaccine must not be used in infants under 6 months of age.

Other medicines and Comirnaty Omicron XBB.1.5

Tell your child's doctor or pharmacist if your child is using, has recently used, or might use any other medicines or has recently received any other vaccine.

Pregnancy and breastfeeding

If your daughter is pregnant, tell her doctor, nurse, or pharmacist before she is given this vaccine.

There are no available data on the use of Comirnaty Omicron XBB.1.5 during pregnancy. However, a large amount of information on pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimesters has not shown adverse effects on pregnancy or the newborn. Although information on the effects on pregnancy or the newborn after vaccination during the first trimester is limited, no change in the risk of spontaneous abortion has been observed. Comirnaty Omicron XBB.1.5 can be used during pregnancy.

There are no available data on the use of Comirnaty Omicron XBB.1.5 during breastfeeding. However, no effects on the newborn/infant are expected. Data on women who were breastfeeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk of adverse effects in breastfed infants. Comirnaty Omicron XBB.1.5 can be used during breastfeeding.

Driving and using machines

Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child's ability to use machines or perform activities such as cycling. Wait until these effects have disappeared before resuming activities that require your child's full attention.

3. How to use Comirnaty Omicron XBB.1.5

Comirnaty Omicron XBB.1.5 is given as an injection of 0.3 ml into a muscle in your child's arm.

Your child will receive 1 injection, regardless of whether they have previously received a COVID-19 vaccine.

If your child has previously received a COVID-19 vaccine, they should not receive a dose of Comirnaty Omicron XBB.1.5 until at least 3 months after the most recent dose.

If your child is immunocompromised, they may receive additional doses of Comirnaty Omicron XBB.1.5.

If you have any other questions about the use of Comirnaty Omicron XBB.1.5, ask your child's doctor, 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

• 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 children from 5 to 11 years of age)
• 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/drowsiness
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as skin rash or itching
• decreased appetite
• dizziness
• excessive sweating, night sweats

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

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

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

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis) that can lead to difficulty breathing, palpitations, or chest pain

Frequency not known(cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the limb where the vaccine was administered
• swelling of the face (swelling of the face may occur in patients who have received dermal filler injections)
• a skin reaction that causes red spots or patches on the skin, which may look like a target or a «bull's eye» with a dark red center surrounded by lighter red rings (erythema multiforme)
• abnormal sensation in the skin, such as tingling or prickling (paresthesia)
• decreased sensitivity, especially in the skin (hypoesthesia)
• heavy menstrual bleeding (most cases do not appear to be serious and are temporary)

Reporting of side effects

If your child experiences any side effects, talk to your child's doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V and include the batch number if available. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Comirnaty Omicron XBB.1.5

Keep this medicine out of the sight and reach of children.

The following information on storage, expiry, and use and handling is intended for healthcare professionals.

Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP. The expiry date is the last day of the month shown.

Store in a freezer at –90 °C to –60 °C.

Store in the original package to protect from light.

The vaccine will be received frozen at –90 °C to –60 °C. The frozen vaccine can be stored at –90 °C to –60 °C or at 2 °C to 8 °C after receipt.

Single-dose vials: If stored frozen at –90 °C to –60 °C, the vaccine packs of 10 single-dose vials can be thawed at 2 °C to 8 °C for 2 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Multidose vials: If stored frozen at –90 °C to –60 °C, the vaccine packs of 10 multidose vials can be thawed at 2 °C to 8 °C for 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Frozen vials: Once removed from the freezer, the unopened vial can be stored and transported refrigerated at 2 °C to 8 °C for a maximum of 10 weeks; do not exceed the expiry date printed (EXP). The outer packaging should be marked with the new expiry date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.

Before use, unopened vials can be stored for a maximum of 12 hours at temperatures between 8 °C and 30 °C.

Thawed vials can be handled in ambient light conditions.

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

Do not use this vaccine if you notice visible particles or a change in color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Comirnaty Omicron XBB.1.5 composition

• The active ingredient of the COVID-19 mRNA vaccine (with modified nucleosides) 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 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 injectable preparations

Product appearance and container contents

The vaccine is a dispersion (pH: 6.9-7.9) between transparent and slightly opalescent that is presented in:

• a single-dose vial of 1 dose, transparent (type I glass), 2 ml, with a rubber stopper and a blue plastic flip-off cap with an aluminum seal; or
• a multi-dose vial of 6 doses, transparent (type I glass), 2 ml, with a rubber stopper and a blue plastic flip-off cap with an aluminum seal.

Size of the single-dose vial package: 10 vials.

Size of the multi-dose vial package: 10 vials.

Only some package sizes may be marketed.

Marketing authorization holder

BioNTech Manufacturing GmbH

An der Goldgrube 12

55131 Mainz

Germany

Phone: +49 6131 9084-0

Fax: +49 6131 9084-2121

service@biontech.de

Manufacturers

BioNTech Manufacturing GmbH

Kupferbergterrasse 17-19

55116 Mainz

Germany

Pfizer Manufacturing Belgium NV

Rijksweg 12

Puurs-Sint-Amands, 2870

Belgium

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tel/Tel: +32 (0)2 554 62 11
• Ceská 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 filiale Latvija, 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 podrocja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizacná 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

Date of last revision of this prospectus:

Scan the code with a mobile device to obtain the prospectus in different languages.

URL: www.comirnatyglobal.com

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Administer Comirnaty Omicron XBB.1.5 via the intramuscular route as a single dose of 0.3 ml regardless of the previous COVID-19 vaccination situation.

For individuals who have previously received a COVID-19 vaccine, Comirnaty Omicron XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Additional doses may be administered to individuals who are severely immunocompromised.

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Handling instructions before use

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

• Checkthat the vial has a blue plastic capand that the product name is Comirnaty XBB.1.5 (10 micrograms)/dose injectable dispersion(children from 5 to 11 years of age).
• If the vial has a different product name on the label, consult the summary of product characteristics or the package leaflet of that formulation.
• If the vial is stored frozen, it must be thawed before use. Frozen vials should be transferred to a refrigerated area between 2 °C and 8 °C to thaw. Ensure that the vials are completely thawed before using them.

• Single-dose vials: a package of 10 single-dose vials may take 2 hours to thaw.
• Multi-dose vials: a package of 10 multi-dose vials may take 6 hours to thaw.

• When transferring the vials to storage between 2 °C and 8 °C, update the expiration date on the box.
• Unopened vials can be stored for a maximum of 10 weeks between 2 °C and 8 °C; do not exceed the printed expiration date (EXP).
• Alternatively, individual frozen vials can be thawed for 30 minutes at temperatures up to 30 °C.
• Before use, unopened vials can be stored for a maximum of 12 hours at temperatures up to 30 °C. Thawed vials can be handled in ambient light conditions.

Preparation of 0.3 ml doses

• Gently mix the vials by inverting them ten times before use. Do not shake them.
• Before mixing, the thawed dispersion may contain amorphous particles of a white to off-white color.
• After mixing, the vaccine should have the appearance of a dispersion between transparent and slightly opalescent without visible particles. Do not use the vaccine if it has visible particles or a color change.
• Check if the vial is a single-dose or multi-dose vial and follow the applicable handling instructions below:

• Single-dose vials

• Extract a single dose of 0.3 ml of vaccine.
• Discard the vial and the remaining volume.

• Multi-dose vials

• Multi-dose vials contain 6 doses of 0.3 ml each.
• Using aseptic technique, clean the vial stopper with a single-use antiseptic swab.
• Extract 0.3 ml of Comirnaty Omicron XBB.1.5 for children from 5 to 11 years of age.

To extract 6 doses from the same vial, use syringes and/or needles with a low dead volume. The combination of syringe and needle with a low dead volume should have a dead volume of 35 microliters or less. If conventional syringes and needles are used, there may not be enough volume to extract a sixth dose from the same vial.

• Each dose must contain 0.3 ml of vaccine.
• If the remaining volume of vaccine in the vial cannot provide a complete dose of 0.3 ml, discard the vial and the remaining volume.
• Record the appropriate time and date on the vial. Discard the vaccine that has not been used 12 hours after the first puncture.

Disposal

Disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.