Comirnaty Original/Omicron BA.1

Package leaflet: Information for the user

Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose suspension for injection

Adults and adolescents from 12 years of age
mRNA COVID-19 vaccine
tozinameran/riltozinameran
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Comirnaty Original/Omicron BA.1 is a vaccine used to prevent COVID-19, a disease caused by SARS-CoV-2. It is administered to adults and adolescents aged 12 years and older.
Comirnaty Original/Omicron BA.1 is indicated solely for individuals who have previously received at least one primary vaccination cycle against COVID-19.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and active blood cells against the virus, thereby providing protection against COVID-19.
Since Comirnaty Original/Omicron BA.1 does not contain the virus to induce immunity, it cannot transmit COVID-19.
The use of this vaccine should be in accordance with official recommendations.

2. What you should know before receiving Comirnaty Original/Omicron BA.1

Comirnaty Original/Omicron BA.1 must not be administered

• 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 previously had a severe allergic reaction or breathing problems after an injection of another vaccine
  or after receiving this vaccine in the past;
• vaccination procedures make you anxious or you have fainted after an injection;
• you have a serious illness or infection with high fever. However, if you have a mild fever or an upper respiratory tract infection (such as a cold), you may still receive the vaccination;
• you have a bleeding disorder, a tendency to bruise easily, or if you are taking medicines to prevent blood clots;
• you have a weakened immune system due to a disease such as HIV infection, or due to medicines that affect the immune system, such as corticosteroids.

Following vaccination with Comirnaty, there is an increased risk of myocarditis (inflammation
of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) (see
section 4). These conditions may develop within a few days after vaccination and have
mostly occurred within 14 days. They have been observed more frequently after the second
dose of the vaccine and in younger males. The risk of myocarditis and pericarditis appears to be lower in
children aged 5 to 11 years compared to those aged 12 to 17 years. Most cases of myocarditis and pericarditis resolve.
Some cases have required intensive care support and fatal cases have been reported. After vaccination, pay particular
attention to signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and seek
immediate medical attention if these symptoms occur.
As with all vaccines, Comirnaty Original/Omicron BA.1 may not fully protect everyone who receives it, and the duration of protection is not known.
The effectiveness of Comirnaty Original/Omicron BA.1 may be reduced in immunocompromised individuals. If you are immunocompromised, you may be given additional doses of Comirnaty Original/Omicron BA.1. In such cases, you should continue to maintain physical precautions to help prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Talk to your doctor about the recommendations most suitable for you.

Children
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose, dispersion for injectable preparation
is not recommended for children under 12 years of age.
Paediatric formulations are available for infants and children aged 6 months and older and for children under 12 years of age. For details, please refer to the package leaflet of the other formulations.
The vaccine is not recommended for infants under 6 months of age.

Other medicines and Comirnaty Original/Omicron BA.1
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, or if you have recently received any other vaccines.

Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine.
Data on the use of Comirnaty Original/Omicron BA.1 in pregnant women are not yet
available. However, a large amount of data from pregnant women vaccinated during the
second and third trimesters of pregnancy with the originally authorized Comirnaty vaccine has not
shown any negative effects on pregnancy or the newborn. Although data on effects on pregnancy or the newborn following
vaccination during the first trimester are limited, no change in the risk of spontaneous abortion has been observed. Comirnaty
Original/Omicron BA.1 may be used during pregnancy.
Data on the use of Comirnaty Original/Omicron BA.1 during breastfeeding are not yet
available. However, the vaccine is not expected to cause effects in breastfed infants. Data from
women who were breastfeeding after administration of the originally authorized Comirnaty vaccine have
not shown any risk of adverse effects in infants. Comirnaty Original/Omicron BA.1
may 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 vehicles or operate machinery. Wait until these
effects have subsided before driving or operating machinery.

3. How Comirnaty Original/Omicron BA.1 is given

Comirnaty Original/Omicron BA.1 is given as a 0.3 mL intramuscular injection in the upper arm.
Comirnaty Original/Omicron BA.1 is indicated only in individuals who have previously received at least one primary vaccination cycle against COVID-19.
Comirnaty Original/Omicron BA.1 may be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Please consult your doctor to confirm your eligibility for receiving the booster dose and the recommended timing for administration.
If you are immunocompromised, you may be given additional doses of Comirnaty Original/Omicron BA.1.
For details on the primary vaccination course in individuals aged 12 years and older, refer to the Summary of Product Characteristics of the corresponding formulations.
If you have any questions about the use of Comirnaty Original/Omicron BA.1, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.1 may cause side effects, although not everybody gets them.

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

• at the injection site: pain, swelling
• fatigue, headache
• muscle pain, joint pain
• chills, fever
• diarrhoea
  Some of these side effects were reported slightly more frequently in adolescents aged 12 to 15 years compared to adults.

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

• redness at the injection site
• nausea, vomiting
• swollen lymph nodes (observed more frequently after a booster dose)

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

• feeling unwell, feeling weak or lack of energy/sleep
• arm pain
• insomnia
• itching at the injection site
• allergic reactions such as rash or itching
• reduced 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 cause shortness of breath, palpitations, or chest pain

Not known (frequency cannot be estimated from the available data)

• severe allergic reaction
• extensive swelling of the vaccinated arm
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections with dermal fillers)
• skin reaction causing red spots or patches on the skin, which may appear target-like or "bull's eye" with a dark red center surrounded by lighter red rings (erythema multiforme)
• unusual skin sensations, such as tingling or prickling (paraesthesia)
• decreased sensation, especially of the skin (hypoesthesia)
• heavy menstrual bleeding (most cases were non-serious and transient)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V, including the batch number if available. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Comirnaty Original/Omicron BA.1

Keep this medicine out of the sight and reach of children.
The following information regarding storage, expiry, 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 that month.
Store frozen at a temperature between -90 °C and -60 °C.
Keep in the original packaging to protect the medicine from light.
The vaccine is supplied frozen at a temperature between -90 °C and -60 °C. Upon receipt, the frozen vaccine may be stored at a temperature between -90 °C and -60 °C or between 2 °C and 8 °C.
If stored frozen between -90 °C and -60 °C, packs of 10 vaccine vials may be thawed at a temperature between 2 °C and 8 °C for up to 6 hours, or individual vials may be thawed at room temperature (not exceeding 30 °C) for 30 minutes.
Once removed from the freezer, unopened vials may be stored and transported in a refrigerator at a temperature between 2 °C and 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.). Record on the outer carton the expiry date for storage at a temperature between 2 °C and 8 °C. Once thawed, the vaccine must not be refrozen.
Before use, unopened vials may be kept for up to 12 hours at a temperature between 8 °C and 30 °C.
After thawing, vials may be handled under normal light conditions.
After first puncture, store the vaccine at a temperature between 2 °C and 30 °C and use within 12 hours, including a maximum transport time of 6 hours. Dispose of any unused vaccine.
Do not use this vaccine if you notice particles in the solution or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Comirnaty Original/Omicron BA.1 contains

• The active substances of the nucleoside-modified anti-COVID-19 mRNA vaccine are called tozinameran and riltozinameran. Each vial contains 6 doses of 0.3 mL, with each dose containing 15 micrograms of tozinameran (Original) and 15 micrograms of riltozinameran (Omicron BA.1).
• 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

Description of the appearance of Comirnaty Original/Omicron BA.1 and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9–7.9), supplied in a 2 mL multidose vial (Type I glass) with a rubber stopper and a grey plastic flip-off cap with an aluminium seal. Each pack contains 6 doses.
Pack sizes: 10 or 195 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Tel: +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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

• België/Belgique/Belgien, Luxembourg/Luxemburg: Pfizer S.A./N.V., Tél/Tel: +32 (0)2 554 62 11
• България: Пфайзер Люксембург САРЛ, Клон, България, Tel: +359 2 970 4333
• Česká 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), Tηλ: +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
• United Kingdom (Northern Ireland): Pfizer Limited, Tel: +44 (0) 1304 616161

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

URL: www.comirnatyglobal.com
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

The dose of Comirnaty Original/Omicron BA.1 is 0.3 mL administered intramuscularly.
Comirnaty Original/Omicron BA.1 is indicated only in individuals who have previously received at least one primary series of a COVID-19 vaccine.
An interval of at least 3 months must elapse between administration of Comirnaty Original/Omicron BA.1 and the previous dose of any anti-COVID-19 vaccine.
Additional doses may be administered to individuals who are severely immunocompromised.

Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Instructions for handling prior to use
Comirnaty Original/Omicron BA.1 must be prepared by a healthcare professional using aseptic techniques to ensure sterility of the prepared dispersion.

• Check that the vial has a grey plastic cap and that the product name is clearly labeled as Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injectable preparation (adults and children aged ≥ 12 years).
• If the vial label displays a different name, refer to the summary of product characteristics for that specific formulation.
• If the vial has been stored frozen, it must be thawed before use. Frozen vials should be transferred to an environment at a temperature between 2 °C and 8 °C for thawing. Up to 6 hours may be required to thaw a pack of 10 vials. Ensure that vials are completely thawed before use.
• When transferring the product to storage at 2 °C to 8 °C, update the expiry date on the carton accordingly.
• Closed vials may be stored at 2 °C to 8 °C for up to 10 weeks, without exceeding the printed expiry date (Exp.).
• Alternatively, individual frozen vials may be thawed for 30 minutes at a temperature not exceeding 30 °C.
• Prior to use, closed vials may be kept for up to 12 hours at a temperature not exceeding 30 °C. After thawing, vials may be handled under ambient light conditions.

Preparation of 0.3 mL doses

• Gently mix by inverting the vials 10 times. Do not shake.

• Before mixing, the thawed dispersion may contain opaque amorphous particles, white to off-white in color.

• After mixing, the vaccine should appear as a white to off-white dispersion, free from visible particles. Do not use the vaccine if visible particles are present or if discoloration occurs.

• Withdraw 0.3 mL of Comirnaty Original/Omicron BA.1. To extract 6 doses from a single vial, precision syringes and/or needles (low dead volume) must be used. The combination of precision syringe and needle must have a dead volume of no more than 35 microliters. When using standard syringes and needles, the residual volume may not be sufficient to withdraw a sixth dose from a single vial.

• Each dose must contain 0.3 mL of vaccine.

• If the remaining volume in the vial is insufficient to provide a complete 0.3 mL dose, discard the vial and any excess volume.

• Clearly record the date and time of expiry on the vial. Discard any unused vaccine within 12 hours of first puncture.

Disposal
Any unused medicinal product and waste material derived from it must be disposed of in accordance with local regulations.