What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53632/0006 .

Comirnaty 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified)

Package leaflet: Information for the user

Comirnaty 10 micrograms/dose concentrate for dispersion for injection

Children 5 to 11 years

COVID-19 mRNA Vaccine (nucleoside modified)

tozinameran

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects your child may get. See the end of section 4 for 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 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.

What is in this leaflet

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

1. What Comirnaty is and what it is used for

Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.

Comirnaty 10 micrograms/dose concentrate for dispersion for injection is given to children from 5 to 11 years of age.

The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

As Comirnaty does not contain the virus to produce immunity, it cannot give your child COVID-19.

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

Comirnaty should not be given

  • if your child is allergic to the active substance or 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 is given the vaccine if your child:

  • has ever had a severe allergic reaction or breathing problems after any other vaccine injection or after having been given Comirnaty in the past.
  • is feeling nervous about the vaccination process or has ever fainted following any needle injection.
  • has a severe illness or infection with high fever. However, your child can have the vaccination if he/she have a mild fever or upper airway infection like a cold.
  • has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots.
  • has a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects the immune system.

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.

As with any vaccine, Comirnaty may not fully protect all those who receive it and it is not known how long you will be protected.

Your child may receive a third dose of Comirnaty. The efficacy of Comirnaty, even after a third dose, may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.

Children

Comirnaty is not recommended for children aged under 5 years.

Other medicines and Comirnaty

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 breast-feeding

If your child is pregnant, tell your doctor, nurse or pharmacist before your child receives this vaccine.

Comirnaty can be used during pregnancy. A large amount of information from pregnant women vaccinated with Comirnaty during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.

Comirnaty can be given during breast-feeding.

Driving and using machines

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

3. How Comirnaty is given

Comirnaty is given after dilution as an injection of 0.2 mL into a muscle of the upper arm.

Your child will receive 2 injections.

It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course.

If your child is immunocompromised, he or she may receive a third dose of Comirnaty at least 28 days after the second dose.

If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all vaccines, Comirnaty 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, redness
  • tiredness
  • headache
  • muscle pain
  • chills
  • joint pain
  • diarrhoea
  • fever

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

  • nausea
  • vomiting

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

  • enlarged lymph nodes (more frequently observed after the booster dose)
  • feeling unwell
  • arm pain
  • insomnia
  • injection site itching
  • allergic reactions such as rash or itching
  • feeling weak or lack of energy/sleepy
  • decreased appetite
  • excessive sweating
  • night sweats

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

  • temporary one sided facial drooping
  • 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 lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain

Not known (cannot be estimated from the available data)

  • severe allergic reaction
  • extensive swelling of the vaccinated limb
  • swelling of the face (swelling of the face may occur in patients who have had facial dermatological fillers)
  • a skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
  • unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
  • decreased feeling or sensitivity, especially in the skin (hypoaesthesia)

Reporting of side effects

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.

If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Comirnaty

Keep this medicine out of the sight and reach of children.

The following information about 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 label after EXP. The expiry date refers to the last day of that month.

Store in freezer at -90 °C to -60 °C for 9 months.

Store in the original package in order to protect from light.

The vaccine will be received frozen at -90 °C to -60 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.

When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine 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 refrigerated at 2 °C to 8 °C for a single period of up to 10 weeks within the 9-month shelf life. The outer carton should be marked with the new discard date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.

Thawed vials can be handled in room light conditions.

After dilution, store and transport the vaccine at 2 °C to 30 °C and use within 12 hours. Discard any unused vaccine.

Do not use this vaccine if you notice particulates in the dilution or discolouration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Comirnaty contains

  • The active substance is COVID-19 mRNA Vaccine called tozinameran. After dilution, the vial contains 10 doses of 0.2 mL with 10 micrograms tozinameran each.
  • The other ingredients 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
    • trometamol
    • trometamol hydrochloride
    • sucrose
    • water for injections

What Comirnaty looks like and contents of the pack

The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 10 doses in a 2 mL clear vial (type I glass), with a rubber stopper and an orange flip-off plastic cap with aluminium seal.

Pack sizes: 10 vials or 195 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder

BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
Email: [email protected]

Manufacturers

BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium

For any information about this medicine, please contact: Medical Information,

Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161

This leaflet was last revised in 04/2022.

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and this leaflet will be updated as necessary.

Ref: bCY 4_0

Pfleet No:

2021-0072678, 2021-0073908, 2022-0075536, 2022-0075537, 2022-0075548