COMIRNATY 10 MICROGRAMS / DOSE CONCENTRATE FOR DISPERSION FOR INJECTION - patient leaflet, side effects, dosage

Patient leaflet - COMIRNATY 10 MICROGRAMS / DOSE CONCENTRATE FOR DISPERSION FOR INJECTION

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.
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

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.

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 third dose may still not provide full immunity to COVID-19 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 or breast-feeding, ask your doctor or pharmacist for advice before your child receives this vaccine.

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

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

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

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

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)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. When completing a report please include the vaccine brand and batch/Lot number if available.

By reporting side effects you can help provide more information on the safety of this medicine.

5

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

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: 195 vials or 10 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

Manufacturers

BioNTech Manufacturing GmbH, Kupferbergterrasse 17 – 19, 55116 Mainz, Germany

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 02/2022.

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 2_1

The following information is intended for healthcare professionals only:

Administer Comirnaty intramuscularly after dilution as a course of 2 doses (0.2 mL each) 3 weeks apart.

A third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised.

Traceability

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

Handling instructions

Comirnaty 10 micrograms/dose should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

DOSE VERIFICATION OF COMIRNATY 10

MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)

Verify that the vial has an orange plastic cap.
If the vial has a purple plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose concentrate for dispersion for injection.
If the vial has a grey plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 30 micrograms/dose dispersion for injection.

HANDLING PRIOR TO USE OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)

If the multidose vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10 vial pack may take 4 hours to thaw. Ensure vials are completely thawed prior to use.
Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C within the 9-month shelf life.
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.

Store for up to 10 weeks at

2 °C to 8 °C

MIXING PRIOR TO DILUTION OF COMIRNATY 10

MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)

Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.

Gently x 10

DILUTION OF COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)

The thawed vaccine must be diluted in its original vial with 1.3 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.

1.3 mL of 0.9% sodium chloride injection

Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.3 mL air into the empty diluent syringe.

Pull back plunger to 1.3 mL to remove air from vial.

Record appropriate date and time. Use within 12 hours after dilution.

PREPARATION OF INDIVIDUAL 0.2 mL DOSES OF

COMIRNATY 10 MICROGRAMS/DOSE CONCENTRATE FOR

DISPERSION FOR INJECTION (CHILDREN 5 TO 11 YEARS)

Gently invert the diluted dispersion 10 times. Do not shake.
The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.

Gently x 10

The diluted vials should be marked with the appropriate date and time.
After dilution, store at 2 °C to 30 °C and use within 12 hours.
Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab.
Withdraw 0.2 mL of Comirnaty for children age 5 to 11 years.

Low dead-volume syringes and/or needles should be used in order to extract 10 doses from a single vial. The low deadvolume syringe and needle combination should have a dead volume of no more than 35 microlitres.

If standard syringes and needles are used, there may not be sufficient volume to extract ten doses from a single vial.

Each dose must contain 0.2 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
Discard any unused vaccine within 12 hours after dilution.

0.2 mL diluted vaccine

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Version: Comirnaty10 TS Orange PIL GB 22_02_02