Comirnaty jn.1 10 microgramos/dosis dispersion inyectable

Product Information for the User

Comirnaty JN.1 10 micrograms/dose dispersible injectable

Children aged 5 to 11 years

mRNA vaccine against COVID-19

brentoviramer

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects your child may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this product information carefully before your child receives this vaccine, as it contains important information for your child.

• Keep this product information, as you may need to refer to it again.
• If you have any doubts, consult your child's doctor, pharmacist, or nurse.
• If your child experiences adverse effects, consult your child's doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

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

Comirnaty JN.1 10 micrograms/dose injectable dispersion is administered to children between 5 and 11 years of age.

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

Since Comirnaty JN.1 does not contain the virus to produce immunity, it cannot cause COVID-19 in your child.

This vaccine must be used in accordance with official recommendations.

Do not administer Comirnaty JN.1

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

Warnings and precautions

Consult your child's doctor, pharmacist, or nurse before your child receives the vaccine if your child:

• has ever had a severe allergic reaction or breathing problems after receiving any other vaccine or after this vaccine was administered in the past;
• is anxious about the vaccination process or has fainted at any time after an injection with a needle;
• has a serious illness or a high fever infection. However, your child may be vaccinated if they have a mild fever or an upper respiratory tract infection such as a cold;
• has a bleeding disorder, forms bruises easily, or uses a medication to prevent blood clotting;
• has a weakened immune system due to a disease such as HIV infection or a medication, such as corticosteroids, that affects the immune system.

There is a higher risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer layer of the heart) after vaccination with Comirnaty (see section 4). These conditions may appear a few days after vaccination and have occurred mainly within 14 days. They have been observed more frequently after the second dose of the vaccine, and more frequently in young males. The risk of myocarditis and pericarditis appears to be lower in children aged 5 to 11 years than in those aged 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been observed. After vaccination, be alert to 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 JN.1 may not protect all people who receive it completely and it is not known how long your child will be protected.

The efficacy of Comirnaty JN.1 may be lower in immunocompromised individuals. If your child is immunocompromised, they may receive additional doses of Comirnaty JN.1. In these cases, your child should continue to follow 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 JN.1 10 micrograms/dose injectable dispersion is not recommended for use in children under 5 years of age.

Pediatric formulations are available for infants and children aged 6 months to 4 years. For more information, see the prospectus for other formulations.

Comirnaty JN.1 is not recommended for use in infants under 6 months of age.

Other medications and Comirnaty JN.1

Inform your child's doctor or pharmacist if your child is using, has used recently, or may need to use any other medication or has received any other vaccine recently.

Pregnancy and breastfeeding

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

No data are available on the use of Comirnaty JN.1 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 negative effects on pregnancy or the newborn. Although information on effects in pregnancy or the newborn after vaccination during the first trimester is limited, no change in the risk of spontaneous abortion has been observed. Comirnaty JN.1 may be used during pregnancy.

No data are available on the use of Comirnaty JN.1 during breastfeeding. However, no effects are anticipated in the newborn/infant. Data on women who were breastfeeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk of adverse effects in newborn/infant. Comirnaty JN.1 may be used during breastfeeding.

Driving and operating machinery

Some of the effects of vaccination mentioned in section 4 (Possible adverse effects) may temporarily affect your child's ability to use machines or perform activities such as riding a bicycle. Wait for these effects to disappear before resuming activities that require your child's full attention.

Comirnaty JN.1 is administered as a 0.3 ml injection into a muscle of 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 JN.1 until at least 3 months after the most recent dose.

If your child is immunocompromised, they may receive additional doses of Comirnaty JN.1.

If you have any other questions about the use of Comirnaty JN.1, ask your child's doctor, pharmacist, or nurse.

Like all vaccines, Comirnaty JN.1 may cause side effects, although not everyone will experience them.

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

• site of injection: pain, swelling
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhea

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

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

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

• unwellness, feeling of weakness 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, nocturnal sweating

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

• temporary paralysis of one side of the face
• allergic reactions such as urticaria 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) that may lead to difficulty breathing, palpitations, or chest pain

Unknown frequency(cannot be estimated from available data)

• severe allergic reaction
• extensive swelling in the limb where the vaccine was administered
• facial swelling (may occur in patients who have received dermal filler injections)
• a skin rash that causes red spots or patches on the skin, which may appear as a target or «bull's-eye» with a dark red center surrounded by pale red rings (erythema multiforme)
• abnormal skin sensation, such as tingling or numbness (paresthesia)
• decreased sensitivity, especially in the skin (hypoaesthesia)
• heavy menstrual bleeding (most cases appear to be non-severe and temporary)

Reporting of side effects

If your child experiences any type of side effect, consult their doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus.

You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

The following information on conservation, expiration, and use and handling is intended for healthcare professionals.

Do not use this medication after the expiration date that appears on the box and on the label after CAD. The expiration date is the last day of the month indicated.

Store in a freezer at between –90 °C and –60 °C.

Store in the original packaging to protect it from light.

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

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

Multi-dose vials: If stored frozen at between –90 °C and –60 °C, the 10 vial containers of the vaccine can be thawed at between 2 °C and 8 °C for 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vials (previously frozen): Once removed from the freezer, the unopened vial can be stored and transported refrigerated at between 2 °C and 8 °C for a maximum of 10 weeks; do not exceed the expiration date printed (CAD). The external packaging should be marked with the new expiration date at between 2 °C and 8 °C. Once thawed, the vaccine cannot be refrozen.

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 between 2 °C and 30 °C and use it within 12 hours, including a maximum transportation time of 6 hours. Discard unused vaccine.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Comirnaty JN.1

• The active ingredient of the COVID-19 mRNA vaccine (with modified nucleosides) is called bretoviramer.

• A single-dose vial contains 1 dose of 0.3 ml with 10 micrograms of bretoviramer per dose.
• A multi-dose vial contains 6 doses of 0.3 ml with 10 micrograms of bretoviramer 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
• hydrochloride of tromethamine
• sucrose
• water for injection

Appearance of the product and contents of the package

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

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

Size of the packaging of single-dose vials: 10 vials.

Size of the packaging of multi-dose vials: 10 vials.

Only some packaging 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

For more 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.,

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
• Ελλáδα: Pfizer Ελλ?ς 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
• Κúπρος: Pfizer Ελλ?ς 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

Last update of this leaflet:

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

URL:www.comirnatyglobal.com

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

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This information is intended solely for healthcare professionals:

Administer Comirnaty JN.1 by intramuscular injection as a single dose of 0.3 ml regardless of the previous vaccination status against COVID-19.

For individuals who have previously received a COVID-19 vaccine, Comirnaty JN.1 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 medicinal product administered must be clearly recorded.

Instructions for handling before use

Comirnaty JN.1 must be prepared by a healthcare professional using an aseptic technique to ensure the sterility of the prepared dispersion.

• Checkthat the vial has ablue plastic capand that theproduct name is Comirnaty JN.1 10 micrograms/dose suspension for injection(children aged 5 to 11 years).
• If the vial has another product name on the label, consult the product's technical data sheet or summary of product characteristics.
• If the vial is stored frozen, it must be thawed before use. Frozen vials must be transferred to a refrigerated area at 2 °C to 8 °C to thaw. Ensure that the vials are completely thawed before use.

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

Preparation of 0.3 ml doses

• Mix the vials gently by inverting them 10 times before use. Do not shake.
• Before mixing, the thawed dispersion may contain amorphous particles of white to off-white color.
• After mixing, the vaccine must have the appearance of a transparent to slightly opalescent dispersion without visible particles. Do not use the vaccine if it presents visible particles or a color change.
• Check if the vial is a single-dose vial or a multi-dose vial and follow the applicable handling instructions below:

• Single-dose vials

• Withdraw a single dose of 0.3 ml of vaccine.
• Dispose of the vial and any remaining volume.

• Multi-dose vials

• Multi-dose vials contain 6 doses of 0.3 ml each.
• Using an aseptic technique, clean the stopper of the vial with a single-use antisepsis swab.
• Withdraw 0.3 ml of Comirnaty JN.1 for children aged 5 to 11 years.

To withdraw 6 doses from the same vial, usejabs and/or needles with low dead volume. The combination of a syringe and needle with 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 withdraw a sixth dose from the same vial.

• Each dose must contain 0.3 ml of vaccine.
• If the remaining volume in the vial is insufficient to provide a complete dose of 0.3 ml, dispose of the vial and any remaining volume.
• Record the appropriate time and date on the vial. Dispose of the unused vaccine 12 hours after the first puncture.

Disposal

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.