COMIRNATY 30 MICROGRAMS / DOSE DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) - patient leaflet, side effects, dosage

Comirnaty

Adults and adolescents from 12 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 you 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 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.

• 1. What Comirnaty is and what it is used for

• 2. What you need to know before you receive 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 30 micrograms/dose dispersion for injection is given to adults and adolescents from 12 years of age and older.

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 you COVID-19.

2 what you need to know before you receive —c comirnaty

Comirnaty should not be given

• if you are 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 you are given the vaccine if:

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

You 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 12 years.

Other medicines and Comirnaty

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive 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 drive or use machines. Wait until these effects have worn off before you drive or use machines.

• 3 How Comirnaty is given

Comirnaty is given as an injection of 0.3 mL into a muscle of your upper arm.

You 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.

A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.

If you are immunocompromised, you 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
• tiredness
• headache
• muscle pain
• chills
• joint pain
• diarrhoea
• fever

Some of these side effects were slightly more frequent in adolescents 12 to15 years than in adults.

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

• injection site redness
• 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 you get 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 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 2 °C to 8 °C for 6 hours or individual vials can be stored 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.

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

Thawed vials can be handled in room light conditions.

After first puncture, 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 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. The vial contains 6 doses of 0.3 mL with 30 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 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a grey 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 as a primary course of 2 doses (0.3 mL each) 3 weeks apart.

A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose in individuals 18 years of age and older.

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 should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

DOSE VERIFICATION OF COMIRNATY 30

MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)

• Verify that the vial has a grey 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 an orange plastic cap, please make reference to the Summary of Product Characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.

HANDLING PRIOR TO USE OF COMIRNATY 30

MICROGRAMS/DOSE DISPERSION FOR INJECTION (12

YEARS AND OLDER)

• 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 6 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.
• Gently mix by inverting vials 10 times prior to use. Do not shake.
• Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous particles.
• After mixing, the vaccine should present as an off-white dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.

Gently x 10

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)

• Using aseptic technique, cleanse the vial stopper with a singleuse antiseptic swab.
• Withdraw 0.3 mL of Comirnaty.

Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume 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 a sixth dose from a single vial.

• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Discard any unused vaccine 12 hours after first puncture. Record the appropriate date/time on the vial.

Disposal

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

Version: Comirnaty30 TS Grey PIL GB 22_02_02