COMIRNATY ORIGINAL/OMICRON BA.4-5 (15/15 MICROGRAMS)/DISPERSIBLE INJECTABLE DOSE

Introduction

Package Leaflet: Information for the User

Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dispersion for injection

Adults and adolescents from 12 years of age

COVID-19 mRNA vaccine (with modified nucleosides)

tozinameran/famtozinameran

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get 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 is Comirnaty Original/Omicron BA.4-5 and what is it used for
2. What you need to know before you receive Comirnaty Original/Omicron BA.4-5
3. How Comirnaty Original/Omicron BA.4-5 is given
4. Possible side effects
5. Storage of Comirnaty Original/Omicron BA.4-5
6. Contents of the pack and other information

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

Comirnaty Original/Omicron BA.4-5 is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus. It is given to adults and adolescents from 12 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, providing protection against COVID-19.

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

2. What you need to know before you receive Comirnaty Original/Omicron BA.4-5

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

• if you are 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 you receive the vaccine if:

• you have ever had a severe allergic reaction or breathing problems after being given any other vaccine or after you were given Comirnaty or Comirnaty Original/Omicron BA.4-5 in the past;
• you are nervous about the vaccination process or have fainted after an injection with a needle;
• you have a severe illness or infection with a high fever. However, you can be vaccinated if you have a mild fever or an upper respiratory tract infection such as a cold;
• you have a bleeding problem, bruise easily, or are taking a medicine to prevent blood clotting;
• you have 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 conditions can occur within a few days of 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 between 5 and 11 years of age than in those between 12 and 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 fully protect all people 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, your close contacts should be vaccinated as appropriate. Discuss individual recommendations with your doctor.

Children

Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dispersion for injection is not recommended for use in children under 12 years of age.

A pediatric presentation is available for children between 5 and 11 years of age. For more information, see the package leaflet for Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/concentrate for dispersion for injection.

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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine or have recently received any other vaccine.

Pregnancy and breastfeeding

If you are pregnant or think you might be pregnant, tell your doctor, nurse, or pharmacist before you receive 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 on 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 children. 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 your ability to drive or use machines. Wait until these effects have gone before you drive or use machines.

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

Comirnaty Original/Omicron BA.4-5 is given as an injection of 0.3 ml into a muscle in the arm.

Comirnaty Original/Omicron BA.4-5 can be given 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.

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

For detailed information on the primary vaccination schedule in individuals 12 years of age and older, see the package leaflet for Comirnaty 30 micrograms/dispersion for injection or Comirnaty 30 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

Some of these side effects were slightly more frequent in adolescents between 12 and 15 years of age than in adults.

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

• redness at the injection site
• nausea
• vomiting

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 (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 prickling (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 you experience 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 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 will be 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.

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

Multidose vials: If stored frozen at –90 °C to –60 °C, the packs of 10 multidose vials of the vaccine can be thawed at 2 °C to 8 °C for 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Frozen vials: Once removed from the freezer, the unopened vial can be stored and transported refrigerated at 2 °C to 8 °C for a maximum of 10 weeks; do not exceed the expiry date printed (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.

Opened vials: After the first puncture, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes a transport time of up to 6 hours. Discard unused vaccine.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Comirnaty Original/Omicron BA.4-5 Composition

• The active ingredients of the COVID-19 mRNA vaccine are tozinameran and famtozinameran.
• • A single-dose vial contains 1 dose of 0.3 ml with 15 micrograms of tozinameran and 15 micrograms of famtozinameran (Omicron BA.4-5) per dose.
  • A multi-dose vial contains 6 doses of 0.3 ml with 15 micrograms of tozinameran (Original) and 15 micrograms of famtozinameran (Omicron BA.4-5) 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 injectable preparations

Product Appearance 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 single-dose vial of 1 dose, transparent (type I glass), 2 ml, with a rubber stopper and a gray plastic flip-off cap with an aluminum seal.
• A multi-dose vial of 6 doses, transparent (type I glass), 2 ml, with a rubber stopper and a gray plastic flip-off cap with an aluminum seal.

Size of the single-dose vial container: 10 vials.

Sizes of the multi-dose vial container: 10 vials or 195 vials. Only some package 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 the 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 for this product is available 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 0.3 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 product must be clearly recorded.

Handling Instructions

Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose must be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

Disposal

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