Comirnaty jn.1 3 microgramos/dosis concentrado para dispersion inyectable

Product Information for the User

Comirnaty JN.1 3 microgram/dose concentrated for injection

Infants and children aged 6 months to 4 years

mRNA vaccine against COVID-19

brentuzumab

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 questions, 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 3 microgram/dose concentrated for injection is administered to infants and children between 6 months and 4 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.

Because 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.

Comirnaty JN.1 should not be administered

• 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 with 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 receiving this vaccine in the past;
• is anxious about the vaccination process or has fainted at any time after receiving 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, easily forms bruises, 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 vaccination, 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 appear.

Like 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 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 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 3 microgram/dose concentrate for injection is not recommended for use in children under 5 to 11 years of age.

Pediatric formulations are available for children aged 5 to 11 years. For more information, see the prospectus for other formulations.

The vaccine 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

Comirnaty JN.1 3 microgram/dose concentrate for injection is not indicated for use in individuals over 5 years of age.

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

Driving and operating machinery

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

If your child is an infant between 6 months and less than 12 months of age, they will receive Comirnaty JN.1 with ayellow stopperafter dilution in the form of an injection of0.3 mlin a thigh muscle. If your child is an infant or a child 1 year of age or older, they will receive Comirnaty JN.1 with ayellow stopperafter dilution in the form of an injection of0.3 mlin a thigh muscle or in an arm muscle.

If your child has not completed a primary vaccination schedule for COVID-19 or has not had COVID-19 previously, they will receive a maximum of three injections (the total number of doses needed as a primary schedule). It is recommended to receive the second dose 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 for 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 JN.1 until at least 3 months after the most recent dose.

If your child turns 5 years of age between doses of the primary schedule, they must complete the primary schedule with the same dose level of 3 micrograms.

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

Interchangeability

Your child may receive any previous or current Comirnaty vaccine 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 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

• irritability (between 6 months and <2>

• injection site: pain/tenderness, swelling
• fatigue, headache
• drowsiness (between 6 months and <2>
• muscle pain, joint pain
• chills, fever
• diarrhea

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

• nausea
• vomiting («very common» in pregnant women aged 18 years and older and in immunocompromised individuals aged 2 to 18 years)
• redness at the injection site («very common» in children aged 6 months to 11 years and in immunocompromised individuals aged 2 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 («common» in children aged 6 months to <2>
• decreased appetite («very common» in children aged 6 months to <2>
• 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 fillers)
• a skin reaction that causes red spots or patches on the skin, which may appear as a target or a «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 do not appear to be severe and are temporary)

Reporting of side effects

If your child experiences any type of side effect, consult your child's 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 intheAppendix 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.

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 2 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 outer 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.

After dilution, store the vaccine at between 2 °C and 30 °C and use it within 12 hours, including a transportation time of up to 6 hours. Discard unused vaccine.

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

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. After dilution, the vial with ayellow closurecontains3 doses of 0.3 mlwith 3 micrograms of bretoviramer each.

• 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) of color between white and off-white that is presented in a multi-dose vial of3 doses, transparent (type I glass), of 2 ml, with a rubber stopper and with aplastic flip-off closure of yellow colorwith 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/Luxembourgg: Pfizer S.A./N.V.,

Tel/Tel: +32 (0)2 554 62 11

• Czech Republic: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Denmark: Pfizer ApS, Tlf: +45 44 201 100
• Germany: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Estonia: Pfizer Luxembourg SARL Estonian filial, Tel: +372 666 7500
• Greece: Pfizer Greece A.E., Τηλ.: +30 210 6785 800
• Spain: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Croatia: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633363 (toll free), +44 (0)1304 616161
• Iceland: Icepharma hf, Simi: +354 540 8000
• Italy: Pfizer S.r.l., Tel: +39 06 33 18 21
• Cyprus: Pfizer Greece A.E. (Cyprus Branch), Tηλ: +357 22 817690
• Latvia: Pfizer Luxembourg SARL filiale Latvija,Tel.: +371 670 35 775
• Lithuania: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Hungary: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norway: Pfizer AS, Tlf: +47 67 526 100
• Netherlands: Pfizer BV, Tel: +31 (0)10 406 43 01
• Austria: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Poland: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• Romania: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenia: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja

farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400

• Slovak Republic: Pfizer Luxembourg SARL, organisational unit, Tel: +421 2 3355 5500
• Finland: Pfizer Oy, Puh/Tel: +358(0)9 430 040
• Sweden: Pfizer AB, Tel: +46 (0)8 550 520 00
• United Kingdom (Northern Ireland): Pfizer Limited, Tel: +44 (0) 1304 616161

Last review date of this leaflet:

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

URL:www.comirnatyglobal.com

Detailed information about this medicine 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:

If the child has not completed a primary vaccination course against COVID-19 or has no history of previous SARS-CoV-2 infection, administer Comirnaty JN.1 with ayellow closureby intramuscular injection after dilution as a primary vaccination course of a maximum of 3 doses (the total number of doses required as a primary vaccination course); 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 vaccination course.

If the child has completed a primary vaccination course against COVID-19 or has a history of previous SARS-CoV-2 infection, administer Comirnaty JN.1 with ayellow closureby intramuscular injection after dilution as a single dose of0.3 ml. If the person has previously received a COVID-19 vaccine, they should receive a dose of Comirnaty JN.1 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.

Instructions for handling before use

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

• Checkthat the vial has aplastic closure of yellow colorand that theproduct name is Comirnaty JN.1 3 micrograms/dose concentrated for injectable dispersion(infants and children from 6 months to 4 years of age).
• If the vial has another product name on the label or a closure of a different color, refer to the product's technical file or summary of product characteristics for that formulation.
• If the vial is stored frozen, it must be thawed before use. Frozen vials must 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 on the box.

• Unopened vials can bestored for a maximum of 10 weeks between 2 °C and 8 °C; do not exceed the printed expiration date (CAD).
• 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.

Dilution for a vial with a yellow closure

• Allow the thawed vial to reach ambient temperature and invert it gently 10 times before dilution. Do not shake.
• Before dilution, the thawed dispersion may contain amorphous white or off-white particles.
• The vaccine must be diluted in its original vial with1.1 ml of a 0.9% sodium chloride solution (9 mg/ml)using a 21G or finer needle and aseptic techniques.
• Equate the pressure of the vial before removing the needle from the stopper of the vial by extracting 1.1 ml of air into the empty diluent syringe.
• Invert the diluted dispersion gently 10 times. Do not shake.
• The diluted vaccine must have the appearance of a white or off-white dispersion without visible particles. Do not use the diluted vaccine if it presents visible particles or a color change.
• The diluted vials must be marked with thedate and time of disposalappropriate.
• After dilution, the vials must be stored between 2 °C and 30 °C and used within12 hours.
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to reach ambient temperature before using it.

Preparation of 0.3 ml doses using a vial with a yellow closure

• After dilution, the vial contains 1.58 ml from which3 dosesof0.3 mlcan be obtained.
• Using aseptic technique, clean the stopper of the vial with a single-use antisepsis swab.
• Extract0.3 mlof Comirnaty JN.1 for infants and children from 6 months to 4 years of age. Conventional syringes and needles can be used to extract 3 doses from the same vial.
• Each dose must contain0.3 mlof vaccine.
• If the remaining vaccine volume in the vial cannot provide a complete dose of0.3 ml, discard the vial and the excess volume.
• Discard the unused vaccine within 12 hours after dilution.

Disposal

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