Comirnaty LP.8.1 30 micrograms/dose injectable dispersion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Comirnaty LP.8.1 30 micrograms/dose injectable dispersion (frozen vials)

Adults and adolescents from 12 years of age

mRNA vaccine against COVID-19

mRNA encoding LP.8.1

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read the entire leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before receiving Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is administered
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

1. What Comirnaty LP.8.1 is and what it is used for

Comirnaty LP.8.1 is a vaccine used to prevent COVID-19 caused by SARS-CoV-2.

Comirnaty LP.8.1 30 micrograms/dose injectable dispersion is administered to adults and adolescents from 12 years of age.

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

Since Comirnaty LP.8.1 does not contain the virus to produce immunity, it cannot cause COVID-19.

This vaccine should be used in accordance with official recommendations.

2. What you need to know before receiving Comirnaty LP.8.1

Comirnaty LP.8.1 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 receiving the vaccine if:

• you have ever had a severe allergic reaction or breathing problems after an injection of any other vaccine or after receiving this vaccine in the past;
• you are anxious about the vaccination process or have ever fainted after an injection with a needle;
• you have a serious illness or an infection with a high fever. However, you may still be vaccinated if you have a mild fever or an upper respiratory tract infection such as a cold;
• you have a bleeding disorder, bruise easily, or take a medicine to prevent blood clots;
• you have a weakened immune system due to a disease such as HIV infection, or due to medicines such as corticosteroids that affect 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) following vaccination with Comirnaty (see section 4). These conditions may occur within 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 aged 5 to 11 years than in those aged 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been reported. After vaccination, you should be alert for signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek immediate medical attention if these occur.

As with any vaccine, Comirnaty LP.8.1 may not fully protect all individuals who receive it, and it is not known how long protection will last.

The effectiveness of Comirnaty LP.8.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may receive additional doses of Comirnaty LP.8.1. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss with your doctor the appropriate individual recommendations.

Children

Use of Comirnaty LP.8.1 30 micrograms/dose injectable dispersion is not recommended in children under 12 years of age.

Paediatric formulations are available for infants from 6 months of age and children under 12 years of age. For more information, please refer to the package leaflet of other formulations.

The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty LP.8.1

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, or if you have recently received any other vaccine.

Comirnaty LP.8.1 can be given at the same time as an influenza vaccine.

In adults aged 18 years and older, Comirnaty LP.8.1 can be given at the same time as a pneumococcal conjugate vaccine (PCV).

In adults aged 18 years and older, Comirnaty LP.8.1 can be given at the same time as a respiratory syncytial virus (RSV) vaccine.

In older adults aged 65 years and above, Comirnaty LP.8.1 can be given at the same time as a high-dose influenza vaccine and an RSV vaccine.

Pregnancy and breastfeeding

If you are pregnant or think you might be pregnant, inform your doctor, nurse, or pharmacist before receiving this vaccine.

There are currently no available data on the use of Comirnaty LP.8.1 during pregnancy. However, a large amount of information on pregnant women vaccinated with the originally approved Comirnaty vaccine during the second and third trimesters has not shown any negative effects on pregnancy or the newborn. Although information on effects during pregnancy or on the newborn following vaccination in the first trimester is limited, no change in the risk of spontaneous abortion has been observed. Comirnaty LP.8.1 may be used during pregnancy.

There are currently no available data on the use of Comirnaty LP.8.1 during breastfeeding. However, effects on the newborn/infant are not expected. Data from women who were breastfeeding after vaccination with the originally approved Comirnaty vaccine have not shown a risk of adverse effects in breastfed infants/newborns. Comirnaty LP.8.1 may be used during breastfeeding.

Driving and using machines

Some of the side effects mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have subsided before driving or using machines.

3. How Comirnaty LP.8.1 is administered

Comirnaty LP.8.1 is administered as a 0.3 ml injection into a muscle of the arm.

You will receive 1 injection, regardless of whether you have previously received a COVID-19 vaccine.

If you have previously received a COVID-19 vaccine, you should not receive a dose of Comirnaty LP.8.1 until at least 3 months after your most recent dose.

If you are immunocompromised, you may receive additional doses of Comirnaty LP.8.1.

If you have any further questions about the use of Comirnaty LP.8.1, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty LP.8.1 may cause side effects, although not everyone experiences them.

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

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

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

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

• nausea
• vomiting (‘very common’ in pregnant women aged 18 years and older and in immunocompromised individuals aged 12 to 18 years)
• redness at the injection site (‘very common’ in immunocompromised individuals aged 12 years and older)
• enlarged lymph nodes (observed more frequently after a booster dose)

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

• malaise, feeling unwell or lack of energy/somnolence
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• decreased appetite
• dizziness
• excessive sweating, night sweats

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

• temporary facial paralysis on one side of the face
• allergic reactions such as hives or facial swelling

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), which may lead to shortness of breath, palpitations, or chest pain

Frequency not known (cannot be estimated from available data)

• severe allergic reaction
• extensive swelling in the limb where the vaccine was administered
• swelling of the face (facial swelling may occur in patients who have received dermal filler injections)
• a skin reaction causing red spots or lesions on the skin, which may resemble a target or “bull’s eye” with a dark red center surrounded by paler red rings (erythema multiforme)
• abnormal skin sensations, such as tingling or pins and needles (paresthesia)
• reduced sensitivity, especially in the skin (hypoesthesia)
• heavy menstrual bleeding (most cases do not appear to be serious and are temporary in nature)

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Comirnaty LP.8.1

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 stated on the carton and label after EXP. The expiry date refers to the last day of the month indicated.

Store in a freezer at between –90 °C and –60 °C.

Keep in the original packaging to protect from light.

The vaccine will be received frozen at between –90 °C and –60 °C. The frozen vaccine may be stored at between –90 °C and –60 °C or at between 2 °C and 8 °C after receipt.

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

Thawed (previously frozen) vials: Once removed from the freezer, unopened vials may be stored and transported refrigerated at between 2 °C and 8 °C for up to 10 weeks; do not exceed the printed expiry date (EXP). The outer packaging should be marked with the new expiry date for storage at between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.

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

Thawed vials may be handled under ambient light conditions.

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

Do not use this vaccine if visible particles or a change in colour is observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Comirnaty LP.8.1

• The active substance in the mRNA vaccine against COVID-19 (with modified nucleosides) is called mRNA encoding LP.8.1.

• A multidose vial contains 6 doses of 0.3 mL each, with 30 micrograms of mRNA encoding LP.8.1 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 injections

Presentation of the product and contents of the pack

The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a 2 mL transparent multidose vial (Type I glass), with a rubber stopper and a grey flip-off plastic cap sealed with an aluminium seal.

Pack size of multidose vials: 10 vials.

Marketing Authorisation Holder

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

Manufacturers

BioNTech Manufacturing GmbH
Kupferbergterrasse 17-19
55116 Mainz
Germany

Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium

Further information about this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder.

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• Ceská republika: Pfizer, spol. s r.o., Tel: +420 283 004 111
• Danmark: Pfizer ApS, Tlf.: +45 44 201 100
• Deutschland: BioNTech Manufacturing GmbH, Tel: +49 6131 90840
• Eesti: Pfizer Luxembourg SARL Eesti filiaal, Tel: +372 666 7500
• Ελλάδα: Pfizer Ελλάς A.E., Τηλ.: +30 210 6785 800
• España: Pfizer, S.L., Tel: +34914909900
• France: Pfizer, Tél +33 1 58 07 34 40
• Hrvatska: Pfizer Croatia d.o.o., Tel: +385 1 3908 777
• Ireland: Pfizer Healthcare Ireland, Tel: 1800 633 363 (toll free), +44 (0)1304 616161
• Ísland: Icepharma hf, Simi: +354 540 8000
• Italia: Pfizer S.r.l., Tel: +39 06 33 18 21
• Κύπρος: Pfizer Ελλάς Α.Ε. (Cyprus Branch), Τηλ: +357 22 817690
• Latvija: Pfizer Luxembourg SARL filiāle Latvijā, Tel.: +371 670 35 775
• Lietuva: Pfizer Luxembourg SARL filialas Lietuvoje, Tel. +370 52 51 4000
• Magyarország: Pfizer Kft, Tel: +36 1 488 3700
• Malta: Vivian Corporation Ltd., Tel: +35621 344610
• Norge: Pfizer AS, Tlf: +47 67 526 100
• Nederland: Pfizer BV, Tel: +31 (0)10 406 43 01
• Österreich: Pfizer Corporation Austria Ges.m.b.H, Tel: +43 (0)1 521 15-0
• Polska: Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00
• Portugal: Laboratórios Pfizer, Lda., Tel: +351 21 423 5500
• România: Pfizer Romania S.R.L, Tel: +40 (0) 21 207 28 00
• Slovenija: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana, Tel.: +386 (0) 1 52 11 400
• Slovenská republika: Pfizer Luxembourg SARL, organizačná zložka, Tel: +421 2 3355 5500
• Suomi/Finland: Pfizer Oy, Puh/Tel: +358 (0)9 430 040
• Sverige: Pfizer AB, Tel: +46 (0)8 550 520 00

Date of the most recent review of this leaflet:

Scan the code with a mobile device to access the leaflet in multiple languages.

URL: www.comirnatyglobal.com

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Administer Comirnaty LP.8.1 by intramuscular injection as a single 0.3 mL dose regardless of prior vaccination status against COVID-19.

For individuals who have previously received a vaccine against COVID-19, Comirnaty LP.8.1 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Additional doses may be administered to individuals who are severely immunocompromised.

Traceability

To improve the traceability of biological medicinal products, the name and batch number of the administered medicine should be clearly recorded.

Handling instructions prior to use for frozen vials

Comirnaty LP.8.1 must be prepared by a healthcare professional using an aseptic technique to ensure sterility of the prepared dispersion.

• Check that the vial has a grey plastic cap and that the product name is Comirnaty LP.8.1 30 micrograms/dose injectable dispersion (for individuals 12 years of age and older).
• If the vial has a different product name on the label, refer to the product information or summary of product characteristics for that formulation.
• If the vial is stored frozen, it must be thawed before use. Frozen vials should be transferred to a refrigerated area between 2 °C and 8 °C to thaw. Ensure that vials are completely thawed before use. A pack of 10 multidose vials may take up to 6 hours to thaw.
• When transferring vials to storage between 2 °C and 8 °C, update the expiry date on the carton.
• Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; do not exceed the printed expiry date (EXP).
• Alternatively, individual frozen vials can be thawed for 30 minutes at temperatures up to 30 °C.
• Prior to use, unopened vials can be kept for up to 12 hours at temperatures up to 30 °C. Thawed vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix the vials by inverting them ten times before use. Do not shake.
• Before mixing, the thawed dispersion may contain white to off-white amorphous particles.
• After mixing, the vaccine should appear as a white to off-white dispersion without visible particles. Do not use the vaccine if visible particles are present or if there is a change in colour.
• Using an aseptic technique, clean the vial stopper with a single-use antiseptic swab.
• Withdraw 0.3 mL of Comirnaty LP.8.1.
• To withdraw 6 doses from a single vial, low dead-volume syringes and/or needles must be used. The combination of syringe and needle with low dead volume should have a dead volume of no more than 35 microliters. If conventional syringes and needles are used, there may not be sufficient volume to withdraw a sixth dose from the same vial.
• Each dose must contain 0.3 mL of vaccine.
• If the remaining volume in the vial cannot provide a complete dose of 0.3 mL, discard the vial and any remaining vaccine.
• Record the appropriate time and date on the vial. Discard any unused vaccine 12 hours after the first puncture.

Disposal

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.