Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion

Infants and children between 6 months and 4 years of age

mRNA COVID-19 vaccine

mRNA encoding LP.8.1

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects your child may experience. Information on how to report side effects is included at the end of section 4.

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

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

Contents of the leaflet

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before your child receives Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19 caused by SARS-CoV-2.

Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion 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 LP.8.1 does not contain the virus needed to produce immunity, it cannot cause COVID-19 in your child.

This vaccine should be used in accordance with official recommendations.

2. What you need to know before your child receives Comirnaty LP.8.1

Comirnaty LP.8.1 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 receives the vaccine if your child:

• has ever had a severe allergic reaction or breathing problems after an injection of any other vaccine or after receiving this vaccine in the past;
• is anxious about the vaccination process or has ever fainted after an injection with a needle;
• has a serious illness or an infection with a high fever. However, your child may still be vaccinated if they have a mild fever or an upper respiratory tract infection such as a cold;
• has a bleeding disorder, bruises easily, or is taking a medicine to prevent blood clots;
• has a weakened immune system due to a disease such as HIV infection or due to medicines such as corticosteroids that affect 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) following vaccination with Comirnaty (see section 4). These conditions may occur within a few days of vaccination and have mostly occurred within 14 days. They have been observed more frequently after the second dose of the vaccine and more commonly 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 reported. After vaccination, you should be alert for signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and seek immediate medical attention if any of these occur.

As with any vaccine, Comirnaty LP.8.1 may not fully protect all individuals who receive it, and it is not known how long your child will be protected.

The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If your child is immunocompromised, they may receive additional doses of Comirnaty LP.8.1. In such cases, your child should continue to maintain physical precautions to help prevent COVID-19. In addition, your child’s close contacts should be vaccinated as appropriate. Discuss with your child’s doctor the appropriate individual recommendations.

Children

The use of Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion is not recommended in children under 5 to 11 years of age.

Paediatric formulations are available for children aged 5 to 11 years. For more information, please refer to the package leaflet of other formulations.

The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty LP.8.1

Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines or has recently received any other vaccines.

Pregnancy and breastfeeding

Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion is not indicated for individuals over 5 years of age.

For detailed information on use in individuals over 5 years of age, please refer to the package leaflet of other formulations.

Driving and use of machines

Some of the side 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 riding a bicycle. Wait until these effects have subsided before resuming activities requiring your child’s full attention.

3. How Comirnaty LP.8.1 is administered

If your child is an infant between 6 months and less than 12 months of age, they will receive Comirnaty LP.8.1 with a yellow cap after dilution as an injection of 0.3 ml into a muscle in the thigh. If your child is an infant or child aged 1 year or older, they will receive Comirnaty LP.8.1 with a yellow cap after dilution as an injection of 0.3 ml 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 previously had COVID-19, they will receive up to three injections (the total number of doses required as a primary schedule). The second dose should 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 LP.8.1 until at least 3 months after their most recent dose.

If your child turns 5 years old between their primary schedule doses, they should complete the primary schedule with the same 3-microgram dose level.

If your child is immunocompromised, they may receive additional doses of Comirnaty LP.8.1.

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 required as a primary schedule. Your child should only receive the primary schedule once.

If you have any further questions about the use of Comirnaty LP.8.1, please ask your child's doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 may cause side effects, although not everybody gets them.

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

• irritability (in children from 6 months to less than 2 years of age)
• injection site: pain/tenderness, swelling
• fatigue, headache
• drowsiness (in children from 6 months to less than 2 years of age)
• muscle pain, joint pain
• chills, fever
• diarrhoea

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)
• enlarged lymph nodes (observed more frequently after a booster dose)

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

• malaise, feeling unwell or lack of energy/somnolence
• pain in the arm
• insomnia
• itching at the injection site
• allergic reactions such as rash (‘common’ in children aged 6 months to less than 2 years) or itching
• decreased appetite (‘very common’ in children aged 6 months to less than 2 years)
• dizziness
• excessive sweating, night sweats

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

• temporary facial paralysis
• 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), which may lead to difficulty breathing, palpitations, or chest pain

Frequency not known (cannot be estimated from available data)

• severe allergic reaction
• extensive swelling in the limb where the vaccine was administered
• swelling of the face (facial swelling may occur in patients who have received dermal filler injections)
• a skin reaction causing red spots or patches on the skin, which may resemble a target or “bull’s eye” with a dark red center surrounded by paler red rings (erythema multiforme)
• abnormal sensation in the skin, such as tingling or prickling (paraesthesia)
• reduced sensation, especially in the skin (hypoesthesia)
• heavy menstrual bleeding (most cases do not appear to be serious and are temporary in nature)

Reporting of side effects

If your child experiences any side effects, talk to your child’s doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet.

You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Comirnaty LP.8.1

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 stated on the carton and label after EXP. The expiry date refers to 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 from light.

The vaccine is received frozen at between –90 °C and –60 °C. The frozen vaccine may 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 packs of 10 vials of vaccine may be thawed at between 2 °C and 8 °C for up to 2 hours or individual vials may be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vials (previously frozen): After removal from the freezer, unopened vials may be stored and transported refrigerated at between 2 °C and 8 °C for up to 10 weeks; do not exceed the printed expiry date (EXP). The outer packaging must be labelled with the new expiry date for storage at between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.

Prior to use, unopened vials may be stored for up to 12 hours at temperatures between 8 °C and 30 °C.

Thawed vials may be handled under ambient light conditions.

After dilution, store the vaccine at between 2 °C and 30 °C and use within 12 hours, which includes up to 6 hours of transport time. Discard any unused vaccine.

Do not use this vaccine if visible particles or a change in colour is observed in the diluted solution.

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

6. Contents of the pack and other information

Composition of Comirnaty LP.8.1

• The active substance in the mRNA vaccine against COVID-19 (with modified nucleosides) is called mRNA encoding LP.8.1. After dilution, the vial with a yellow flip-off cap contains 3 doses of 0.3 ml each, with 3 micrograms of mRNA encoding LP.8.1 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 injections

Presentation of the product and contents of the container

The vaccine is a dispersion (pH: 6.9–7.9), ranging from transparent to slightly opalescent, supplied in a 3-dose multidose vial, clear (type I glass), 2 ml in size, with a rubber stopper and a yellow plastic flip-off cap sealed with an aluminum seal.

Pack size: 10 vials.

Marketing Authorization Holder

BioNTech Manufacturing GmbH

An der Goldgrube 12

55131 Mainz

Germany

Telephone: +49 6131 9084-0

Fax: +49 6131 9084-2121

[email protected]

Manufacturers

BioNTech Manufacturing GmbH

Kupferbergterrasse 17-19

55116 Mainz

Germany

Pfizer Manufacturing Belgium NV

Rijksweg 12

Puurs-Sint-Amands, 2870

Belgium

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder.

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/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), Τηλ: +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

Date of the most recent review of this leaflet:

Scan the code with a mobile device to access the leaflet in multiple languages.

URL: www.comirnatyglobal.com

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

This information is intended for healthcare professionals only:

If the child has not completed a primary vaccination series against COVID-19 or has no history of prior SARS-CoV-2 infection, administer Comirnaty LP.8.1 intramuscularly after dilution as a primary series of up to 3 doses (the total number of doses required for the primary series); the second dose should be administered 3 weeks after the first dose, followed by a third dose at least 8 weeks after the second dose to complete the primary series.

If the child has completed a primary vaccination series against COVID-19 or has a history of prior SARS-CoV-2 infection, administer Comirnaty LP.8.1 intramuscularly after dilution as a single dose of 0.3 ml. If the individual has previously received a COVID-19 vaccine, they should receive one dose of Comirnaty LP.8.1 at least 3 months after the most recent dose.

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

Traceability

To improve traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Handling instructions prior to use

Comirnaty LP.8.1 must be prepared by a healthcare professional using aseptic techniques to ensure the sterility of the prepared dispersion.

• Check that the vial has a yellow plastic flip-off cap and that the product name on the label is Comirnaty LP.8.1 3 micrograms/dose concentrate for injectable dispersion (for infants and children aged 6 months to 4 years).
• If the vial has a different product name on the label or a flip-off cap of a different color, consult the product information or summary of product characteristics for that formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to a refrigerated environment (between 2 °C and 8 °C) for thawing; a pack of 10 vials may take up to 2 hours to thaw completely. Ensure that the vials are fully thawed before use.
• When transferring vials to storage between 2 °C and 8 °C, update the expiry date indicated on the carton.
• Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; do not exceed the printed expiry date (EXP).
• Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
• Prior to use, unopened vials may be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials may be handled under ambient light conditions.

Dilution

• Allow the thawed vial to reach room temperature and gently invert it 10 times before dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain amorphous, opaque particles ranging from white to off-white in color.
• The thawed vaccine must be diluted in its original vial with 1.1 ml of 9 mg/ml (0.9 %) sodium chloride injectable solution, using a 21-gauge or finer needle and aseptic techniques.
• Equalize the pressure in the vial before removing the needle from the vial stopper by withdrawing 1.1 ml of air into the empty diluent syringe.
• Gently invert the diluted dispersion 10 times. Do not shake.
• The diluted vaccine should appear as a dispersion ranging from transparent to slightly opalescent, with no visible particles. Do not use the diluted vaccine if visible particles or discoloration are present.
• Diluted vials must be labeled with the appropriate date and time of discard.
• After dilution, vials must be stored at 2 °C to 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 administration.

Preparation of 0.3 ml doses

• After dilution, the vial contains 1.58 ml, from which 3 doses of 0.3 ml can be withdrawn.
• Using aseptic technique, clean the vial stopper with a single-use antiseptic swab.
• Withdraw 0.3 ml of Comirnaty LP.8.1 for infants and children aged 6 months to 4 years. Conventional syringes and needles may be used to withdraw 3 doses from the same vial.
• Each dose must contain 0.3 ml of vaccine.
• If the remaining volume in the vial cannot provide a complete 0.3 ml dose, discard the vial and any remaining vaccine.
• Discard any unused vaccine not used within 12 hours after dilution.

Disposal

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