COMIRNATY ORIGINAL/OMICRON BA.4-5 (5/5 MICROGRAMS)/CONCENTRATED DISPERSION FOR INJECTION

Introduction

Package Leaflet: Information for the User

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/concentrate for dispersion for injection

Children from 5 to 11 years of age

COVID-19 mRNA vaccine (with modified nucleosides)

tozinameran/famtozinameran

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 you may get. The last part of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before your child receives this vaccine, because it contains important information for them.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If your child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Comirnaty Original/Omicron BA.4-5 is and what it is used for
2. What you need to know before your child starts receiving Comirnaty Original/Omicron BA.4-5
3. How Comirnaty Original/Omicron BA.4-5 is administered
4. Possible side effects
5. Storage of Comirnaty Original/Omicron BA.4-5
6. Contents of the pack and further information

1. What Comirnaty Original/Omicron BA.4-5 is and what it is used for

Comirnaty Original/Omicron BA.4-5 is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is administered to children from 5 to 11 years of age.

Comirnaty Original/Omicron BA.4-5 is only indicated in individuals who have previously received at least one primary vaccination schedule against COVID-19.

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

Because Comirnaty Original/Omicron BA.4-5 does not contain the virus to produce immunity, it cannot give your child COVID-19.

2. What you need to know before your child starts receiving Comirnaty Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 must not be administered

• 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 doctor, pharmacist, or nurse before your child receives the vaccine if your child:

• has ever had a severe allergic reaction or breathing problems after injection of any other vaccine or after being given Comirnaty or Comirnaty Original/Omicron BA.4-5 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 high fever. 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, bruises easily, or is taking a medicine to prevent blood clots;
• has a weakened immune system due to a disease such as HIV or due to 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 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 from 5 to 11 years of age than in those from 12 to 17 years of age. After vaccination, you should be alert to the signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and should seek immediate medical attention if they occur.

As with any vaccine, Comirnaty Original/Omicron BA.4-5 may not completely protect all individuals who receive it, and it is not known how long you will be protected.

The efficacy of Comirnaty Original/Omicron BA.4-5 may be lower in immunocompromised individuals. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. Additionally, close contacts should be vaccinated as appropriate. Discuss individual recommendations with your doctor.

Children

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/concentrate for dispersion for injection is not recommended for use in children under 5 years of age.

Other medicines and Comirnaty Original/Omicron BA.4-5

Tell your 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

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

There are no available data on the use of Comirnaty Original/Omicron BA.4-5 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 the effects on pregnancy or the newborn after vaccination during the first trimester is limited, no change in the risk of spontaneous abortion has been observed. Comirnaty Original/Omicron BA.4-5 can be used during pregnancy.

There are no available data on the use of Comirnaty Original/Omicron BA.4-5 during breastfeeding. However, no effects on the newborn/infant are expected. Data on women who were breastfeeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk of adverse effects in breastfed infants. Comirnaty Original/Omicron BA.4-5 can be used during breastfeeding.

Driving and using machines

Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect the ability to use machines or perform activities such as cycling. Wait until these effects have disappeared before resuming activities that require your full attention.

3. How Comirnaty Original/Omicron BA.4-5 is administered

Comirnaty Original/Omicron BA.4-5 is administered after dilution as a 0.2 ml injection into a muscle of the arm.

Comirnaty Original/Omicron BA.4-5 can be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Comirnaty Original/Omicron BA.4-5 is only indicated in individuals who have previously received at least one primary vaccination schedule against COVID-19.

Consult your healthcare professional about eligibility for the booster dose and when to administer it.

For detailed information on the primary vaccination schedule in children from 5 to 11 years of age, refer to the package leaflet of Comirnaty 10 micrograms/concentrate for dispersion for injection.

If you have any further questions on the use of Comirnaty Original/Omicron BA.4-5, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 can cause side effects, although not everybody gets them.

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

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

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

• nausea
• vomiting
• redness at the injection site («very common» in children from 5 to 11 years of age)

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

• enlarged lymph nodes (more frequently observed after the booster dose)
• malaise
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as skin rash or itching
• feeling weak or lack of energy/drowsiness
• decreased appetite
• 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 where the vaccine was administered
• swelling of the face (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 numbness (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 doctor, pharmacist, or nurse, even if it is possible side effects 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 Original/Omicron BA.4-5

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 4 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 may be stored and transported refrigerated at 2 °C to 8 °C for a maximum of 10 weeks; do not exceed the printed expiry date (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 maximum of 6 hours of transport time. 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. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Comirnaty Original/Omicron BA 4-5

• The active ingredients of the COVID-19 mRNA vaccine are tozinameran and famtozinameran. After dilution, the vial contains 10 doses of 0.2 ml with 5 micrograms of tozinameran (Original) and 5 micrograms of famtozinameran (Omicron BA.4-5) per dose.
• 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
  • hydrochloric acid
  • sucrose
  • water for injectable preparations

Appearance of the Product and Container Contents

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

Container sizes: 10 vials or 195 vials

Only some container 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

2870 Puurs

Belgium

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet: {MM/YYYY}

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

URL: www.comirnatyglobal.com

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

The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

This information is intended for healthcare professionals only:

The dose of Comirnaty Original/Omicron BA.4-5 is 0.2 ml administered intramuscularly.

There should be an interval of at least 3 months between the administration of Comirnaty Original/Omicron BA.4-5 and the last previous dose of a COVID-19 vaccine.

Comirnaty Original/Omicron BA.4-5 is only indicated in individuals who have previously received at least one primary vaccination schedule against COVID-19.

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Handling Instructions

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose must be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion

Disposal

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