COMIRNATY OMICRON XBB.1.5 (3 micrograms/dose) Concentrate for injectable dispersion

Introduction

Package Leaflet: Information for the User

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

Infants and children from 6 months to 4 years

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 the leaflet includes 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 is Comirnaty Omicron XBB.1.5 and what is it 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 is Comirnaty Omicron XBB.1.5 and what is it 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 3 micrograms/dose concentrate for dispersion for injection is given to infants and children from 6 months to 4 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 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 a 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 is taking 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 disorders 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 between 5 and 11 years of age than in those between 12 and 17 years of age. Most cases of myocarditis and pericarditis recover. 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 efficacy of Comirnaty may be lower in immunocompromised individuals. If your child is immunocompromised, they may receive additional doses of Comirnaty. 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 3 micrograms/dose concentrate for dispersion for injection is not recommended for use in children under 5 years of age.

Pediatric formulations are available for children from 5 to 11 years of age. For more information, see the package leaflet for other formulations.

The vaccine is not recommended for use 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

Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection is not indicated for individuals over 5 years of age.

For detailed information on use in individuals over 5 years of age, see the package leaflet for other formulations.

Driving and using machines

Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child's ability to use 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

If your child is an infant from 6 months to less than 12 months of age, they will receive Comirnaty Omicron XBB.1.5 after dilution as a 0.2 ml injection into a muscle in the thigh. If your child is an infant or a child of 1 year of age or older, they will receive Comirnaty Omicron XBB.1.5 after dilution as a 0.2 ml injection into a muscle in the thigh or into a muscle in the arm.

If your child has not completed a primary vaccination schedule against COVID-19 or has not had COVID-19 before, they will receive a maximum of three injections (the total number of doses needed as a primary schedule). The second dose is recommended to be given 3 weeks after the first dose, followed by a third dose at least 8 weeks after the second dose, to complete the primary schedule.

If your child has previously completed a primary vaccination schedule against COVID-19 or has had COVID-19, they will receive 1 injection. 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 turns 5 years of age between their doses of the primary schedule, they should complete the primary schedule with the same dose level of 3 micrograms.

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

Interchangeability

Your child may receive Comirnaty, Comirnaty Original/Omicron BA.4-5, or Comirnaty Omicron XBB.1.5 (or a combination) for the primary schedule. Your child should not receive more than the total number of doses needed as a primary schedule. Your child should only receive the primary schedule once.

If you have any further questions on 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

• irritability (between 6 months and <2 years)< li>
• injection site: pain/pain on touch, swelling
• fatigue, headache
• sleepiness (between 6 months and <2 years)< li>
• 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 6 months 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/sleepiness
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as skin rash («common» in children from 6 months to <2 years of age) or itching< li>
• decreased appetite («very common» in children from 6 months to <2 years of age)< li>
• 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 in which the vaccine was administered
• 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 is 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.

If stored frozen at –90 °C to –60 °C, the vaccine packs of 10 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.

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.

After dilution, 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 in the dilution or a color change.

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

6. Contents of the vial and additional information

Composition of Comirnaty Omicron XBB.1.5

• The active ingredient of the COVID-19 mRNA vaccine (with modified nucleosides) is called raxtozinameran. After dilution, the vial contains 10 doses of 0.2 ml with 3 micrograms of raxtozinameran each.
• The other components are:

• ((4-hydroxybutyl)azanediyl)bis(hexano-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

Appearance of the product and packaging contents

The vaccine is a dispersion (pH: 6.9-7.9) of a color between white and off-white that is presented in a 10-dose multidose vial, transparent (type I glass), 2 ml, with a rubber stopper and a flip-offplastic cap of burgundy color with an aluminum seal.

Package size: 10 vials.

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 medicine 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 medicine 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:

If the child has not completed a primary vaccination schedule against COVID-19 or does not have a history of previous SARS-CoV-2 infection, administer Comirnaty Omicron XBB.1.5 by intramuscular injection after dilution as a primary schedule of up to 3 doses (the total number of doses needed as a primary schedule) (0.2 ml each); the second dose is administered 3 weeks after the first dose, followed by a third dose at least 8 weeks after the second dose to complete the primary schedule.

If the child has completed a primary vaccination schedule against COVID-19 or has a history of previous SARS-CoV-2 infection, administer Comirnaty Omicron XBB.1.5 by intramuscular injection after dilution as a single dose of 0.2 ml. If the person has previously received a COVID-19 vaccine, they should receive a dose of Comirnaty Omicron XBB.1.5 at least 3 months after the most recent dose.

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

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine 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 burgundy-colored plastic capand that the product name is Comirnaty Omicron XBB.1.5 (3 micrograms)/dose concentrated for injectable dispersion(infants and children from 6 months to 4 years of age).
• If the vial has a different product name on the label, consult the summary of product characteristics or the product information leaflet for that formulation.
• If the multidose 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; a package of 10 vials may take 2 hours to thaw. Ensure that the vials are completely thawed before using them.
• When transferring the vials to storage between 2 °C and 8 °C, update the expiration date indicated 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.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake it.
• Before dilution, the thawed dispersion may contain opaque, off-white particles.
• The thawed vaccine must be diluted in its original vial with 2.2 ml of a 9 mg/ml (0.9%) sodium chloride injectable solution, using a 21-gauge or thinner needle and aseptic techniques.
• Equalize the pressure in the vial before removing the needle from the vial stopper by withdrawing 2.2 ml of air into the empty diluent syringe.
• Gently invert the diluted dispersion 10 times. Do not shake it.
• The diluted vaccine should have the appearance of a dispersion between white and off-white without visible particles. Do not use the diluted vaccine if it contains visible particles or a color change.
• The diluted vials must be labeled with the date and time of disposal.
• After dilution, the vials must be stored between 2 °C and 30 °C and used within 12 hours.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to reach room temperature before using it.

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 technique, clean the vial stopper with a single-use antiseptic swab.
• Extract 0.2 ml of Comirnaty Omicron XBB.1.5 for infants and children from 6 months to 4 years of age.

To extract 10 doses from the same vial, syringes and/or needles with a low dead volumemust be used. The combination of syringe and needle with a low dead volume must have a dead volume of 35 microliters or less. If conventional syringes and needles are used, there may not be enough volume to extract 10 doses from the same vial.

• Each dose must contain 0.2 ml of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a complete dose of 0.2 ml, discard the vial and the excess volume.
• Discard the vaccine that has not been used within 12 hours after dilution.

Disposal

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