Comirnaty kp.2 30 microgramos/dosis dispersion inyectable

Product Information for the User

Comirnaty KP.2 30 micrograms/dose injectable suspension

Adults and adolescents 12 years of age and older

mRNA vaccine against COVID-19

mRNA encoding KP.2

This medicinal product is subject to additional monitoring, which will expedite the detection of any new safety information. 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 entire 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 doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this product information. See section 4.

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

Comirnaty KP.2 30 microgramos/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 KP.2 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 KP.2

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving the vaccine if:

• you have ever had a severe allergic reaction or breathing problems after receiving any other vaccine or after this vaccine was administered in the past;
• you are anxious about the vaccination process or have fainted after an injection with a needle;
• you have 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;
• you have a bleeding disorder, bruise easily, or use a medication to prevent blood clotting;
• you have 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 occur a few days after 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 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.

Like any vaccine, Comirnaty KP.2 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 KP.2 may be lower in immunocompromised individuals. If your child is immunocompromised, they may receive additional doses of Comirnaty KP.2. In these cases, your child should continue to follow physical precautions to help prevent COVID-19. Additionally, close contacts of your child should be vaccinated as appropriate. Discuss individual recommendations with your child's doctor.

Children

Comirnaty KP.2 30 microgram/dose injectable dispersion is not recommended for use in children under 12 years of age.

Pediatric formulations are available for infants 6 months of age and older and children under 12 years of age. For more information, see the prospectus for other formulations.

Comirnaty KP.2 is not recommended for use in infants under 6 months of age.

Other medications and Comirnaty KP.2

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.

Comirnaty KP.2 can be administered at the same time as a flu vaccine.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine

No data are available on the use of Comirnaty KP.2 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 after vaccination during the first trimester is limited, no change in the risk of spontaneous abortion has been observed. Comirnaty KP.2 can be used during pregnancy.

No data are available on the use of Comirnaty KP.2 during breastfeeding. However, no effects are anticipated in the newborn/baby. Data on women who were breastfeeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk of adverse effects in newborn/baby. Comirnaty KP.2 can be used during breastfeeding.

Driving and operating machinery

Some of the effects of vaccination mentioned in section 4 (Possible adverse effects) may temporarily affect the ability to drive or operate machinery. Wait for these effects to disappear before driving or operating machinery.

Comirnaty KP.2 is administered as a 0.3 ml injection into a muscle of the arm.

You will receive 1 injection, regardless of whether you have previously received a COVID-19 vaccine.

If you have previously received a COVID-19 vaccine, you should not receive a dose of Comirnaty KP.2 until at least 3 months after your most recent dose.

If you are immunocompromised, you may receive additional doses of Comirnaty KP.2.

If you have any other questions about the use of Comirnaty KP.2, ask your doctor, pharmacist, or nurse.

Like all vaccines, Comirnaty KP.2 may cause side effects, although not everyone will experience 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

Some of these side effects were slightly more frequent in adolescents aged 12 to 15 years than in adults.

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 12 to 18 years)
• redness at the injection site («very common» in immunocompromised individuals aged 12 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 fillers)
• a skin reaction 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 do not appear to be severe and are 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 printed expiration date (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.

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 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 KP.2

• The active ingredient of the COVID-19 mRNA vaccine (with modified nucleosides) is called KP.2 mRNA codifier.

• A single-dose vial contains 1 dose of 0.3 ml with 30 micrograms of KP.2 mRNA codifier each.
• A multi-dose vial contains 6 doses of 0.3 ml with 30 micrograms of KP.2 mRNA codifier 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 single-dose vial of 1 dose, transparent (Type I glass), of 2 ml, with a rubber stopper and with a plastic flip-off closure capsule of gray color 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 plastic flip-off closure capsule of gray color 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 commercially available.

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.,

Phone: +32 (0)2 554 62 11

• Ceská republika: Pfizer, spol. s r.o., Phone: +420 283 004 111
• Danmark: Pfizer ApS, Phone: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Phone: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Phone: +372 666 7500
• Ελλáδα: Pfizer Ελλáς A.E., Phone: +30 210 6785 800
• España: Pfizer, S.L., Phone: +34914909900
• France: Pfizer, Phone +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Phone: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Phone: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Phone: +39 06 33 18 21
• Κúπρος: Pfizer Ελλáς Α.Ε. (Cyprus Branch), Phone: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiale Latvija,Phone: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Phone: +370 52 51 4000
• Magyarország: Pfizer Kft, Phone: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Phone: +35621 344610
• Norge: Pfizer AS, Phone: +47 67 526 100
• Nederland: Pfizer BV, Phone: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Phone: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Phone: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Phone: +351 21 423 5500
• România:Pfizer Romania S.R.L, Phone: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s podrocja

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

• Slovenská republika: Pfizer Luxembourg SARL, organizacná zložka, Phone: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: PfizerAB, Phone: +46 (0)8 550 520 00
• United Kingdom (Northern Ireland): Pfizer Limited, Phone: +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

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:https://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Administer Comirnaty KP.2 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 KP.2 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

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 KP.2 must be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

• Checkthat the vial has agray plastic closure capsuleand that theproduct nameis Comirnaty KP.2 30 micrograms/dose dispersion for injection(individuals aged 12 years and older).
• If the vial has another product name on the label, consult 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. Ensure that the vials are completely thawed before use.

• Single-dose vials: a packaging of 10 single-dose vials may take 2 hours to thaw.
• Multi-dose vials: a packaging 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 bestored 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.

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 color between white and off-white.
• 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 the remaining volume.

• Multi-dose vials

• Multi-dose vials contain 6 doses of 0.3 ml each.
• Using aseptic technique, clean the stopper of the vial with a single-use antisepsis swab.
• Withdraw 0.3 ml of Comirnaty KP.2.

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 not sufficient to provide a complete dose of 0.3 ml, dispose of the vial and the 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 been in contact with it will be carried out in accordance with local regulations.