WHO PACKAGE LEAFLET99

Package leaflet: Information for the user
Comirnaty 30 micrograms/dose concentrate for dispersion for injection
Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified)tozinameranThis medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects you may get. See the end of section 4for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or nurse.
x
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.
What is in this leaflet
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.
Comirnaty 30 micrograms/dose concentrate for dispersion for injection is given to adults andadolescents 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 Comirnaty

Comirnaty should not be givenx
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:xyou have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
x
you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
x
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.
x
you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.

100

x

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 occurred inyounger 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 theseoccur.
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 maintainphysical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinatedas appropriate. Discuss appropriate individual recommendations with your doctor.
ChildrenComirnaty 30 micrograms/dose concentrate for dispersion for injection is not recommended forchildren aged under 12 years.
There is a paediatric presentation available for children 5 to 11 years of age. For details, please refer tothe WHO Package Leaflet for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
Other medicines and Comirnaty
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicinesor have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you
receive 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 drive or use machines. Wait until these effects have worn off before you drive or
use machines.
Comirnaty contains potassium and sodiumThis vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially‘sodium-free’.

101

3.

How Comirnaty is given

Comirnaty is given after dilution 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 tocomplete the vaccination course.
A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose inindividuals 12 years of age and older.
If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after thesecond 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 peoplex
injection site: pain, swellingx
tirednessxheadachex
muscle painxchillsx
joint painx
diarrhoeaxfeverSome 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 peoplex
injection site rednessxnauseax
vomiting
Uncommon side effects: may affect up to 1 in 100 peoplexenlarged lymph nodes (more frequently observed after the booster dose)x
feeling unwellx
arm painx
insomniax
injection site itchingx
allergic reactions such as rash or itchingx
feeling weak or lack of energy/sleepyxdecreased appetitex
excessive sweatingxnight sweats
Rare side effects: may affect up to 1 in 1,000 peoplex
temporary one sided facial droopingx
allergic reactions such as hives or swelling of the face102

Very rare side effects: may affect up to 1 in 10,000 peoplex
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)x
severe allergic reactionx
extensive swelling of the vaccinated limbxswelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)xa 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)x
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)xdecreased feeling or sensitivity, especially in the skin (hypoaesthesia)
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. You can also report side effects directly via the national reporting
system 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
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
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. Upon arrival at the country of destination, unopened vials may be
stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks, not exceeding theprinted expiry date (EXP).
Upon moving the vaccine to -25 °C to -15 °C and/or to 2 °C to 8 °C storage, the updated expiry datemust be written on the outer carton and the vaccine should be used or discarded by the expiry date.
The original expiry date should be crossed out.
Store in the original package in order to protect from light.
When stored frozen at -90 °C to -60 °C, a carton of vials of the vaccine can be thawed at 2 °C to 8 °C
for up to 3 hours.
Transfers of frozen vials stored at ultra-low temperature (< -60 °C)
xClosed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage(< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
x
Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low
temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
x
After vial trays are returned to frozen storage following temperature exposure up to 25 °C, theymust remain in frozen storage for at least 2 hours before they can be removed again.

103

Transfers of frozen vials stored at -25 °C to -15 °C
xClosed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may
be at temperatures up to 25 °C for up to 3 minutes.
x
Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage(-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.
Once a vial is removed from the vial tray, it should be thawed for use.
After thawing, the vaccine should be diluted and used immediately. However, in-use stability data
have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to
1 month (31 days) at 2 °C to 8 °C; not exceeding the printed expiry date (EXP). To avoid excesstransportation stress when transported at 2 °C to 8 °C, the vaccine should not be transported for morethan 48 hours.
Thawed vials can be handled in room light conditions.
After dilution, store and transport the vaccine at 2 °C to 8 °C and use within 6 hours. Discard any
unused vaccine.
Once removed from the freezer and diluted, the vials should be marked with the new discard date andtime. Once thawed, the vaccine cannot be re-frozen.
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 tothrow away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Comirnaty containsx
The active substance is COVID-19 mRNA Vaccine called tozinameran. After dilution, the vial
contains 6 doses of 0.3 mL with 30 micrograms tozinameran each.
x
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 potassium chloride potassium dihydrogen phosphate sodium chloride disodium phosphate dihydrate sucrose water for injections
 sodium hydroxide (for pH adjustment) hydrochloric acid (for pH adjustment)
What Comirnaty looks like and contents of the packThe 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 purple flip-off plastic cap with aluminium
seal.
Pack size: 25 vials or 195 vials
Not all pack sizes may be marketed.

104

Manufacturer
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.deThis leaflet was last revised in {MM/YYYY}
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Administer Comirnaty intramuscularly after dilution 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 inindividuals 12 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 numberof the administered product should be clearly recorded.
Handling instructions
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure thesterility of the prepared dispersion.

105

VIAL VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE
FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x Verify that the vial has a purple plasticcap.
x If the vial has a grey plastic cap, please
Purple cap
make reference to the WHO Product
Information for Comirnaty
30 micrograms/dose dispersion for
injection.
x If the vial has an orange plastic cap,
please make reference to the WHO
Product Information for Comirnaty
10 micrograms/dose concentrate fordispersion for injection.

THAWING PRIOR TO DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE
CONCENTRATE FOR DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x The multidose vial is stored frozen andmust be thawed prior to dilution.
Frozen vials should be transferred toan environment of 2 °C to 8 °C to
Frozen vials should
thaw; a carton of vials may take up to
be transferred to an
3 hours to thaw.
environment of 2 °C
x The unopened vial can be stored forto 8 °C to thaw.
up to 1 month at 2 °C to 8 °C; notexceeding the printed expiry date
(EXP). To avoid excess transportationstress when transported at 2 °C to
8 °C, the vaccine should not betransported for more than 48 hours.
x Prior to dilution, allow the thawed vial
to come to 2 °C to 8 °C. Thawed vials
can be handled in room light
conditions.
x Gently invert the vial 10 times prior todilution. Do not shake.
x Prior to dilution, the thawed dispersion
may contain white to off-white opaqueamorphous particles.

106

DILUTION OF COMIRNATY 30 MICROGRAMS/DOSE CONCENTRATE FORDISPERSION FOR INJECTION (12 YEARS AND OLDER)
x The thawed vaccine must be diluted in
its original vial with 1.8 mL sodium
chloride 9 mg/mL (0.9%) solution for
injection, also stored at 2 °C to 8 °C,
using a 21 gauge or narrower needle
and aseptic techniques.

1.8 mL of 0.9% sodium chloride injectionx

Pull back plunger to 1.8 mL to remove air from
vial.

107

Equalise vial pressure before
removing the needle from the vial
stopper by withdrawing 1.8 mL air
into the empty diluent syringe.

xx

Gently invert the diluted dispersion
10 times. Do not shake.
The diluted vaccine should present as
an off-white dispersion with noparticulates visible. Do not use thediluted vaccine if particulates ordiscolouration are present.

Gently × 10xxx

Record appropriate date and time.
Use within 6 hours after dilution.

108

The diluted vials should be marked
with the appropriate date and time.
After dilution, use immediately or
store at 2 ºC to 8 ºC and use within
6 hours.
Do not freeze or shake the diluted
dispersion.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE CONCENTRATE FOR DISPERSION FOR INJECTION(12 YEARS AND OLDER)
x After dilution, the vial contains
2.25 mL from which 6 doses of
0.3 mL can be extracted.
x Using aseptic technique, cleanse thevial stopper with a single-use
antiseptic swab.
x Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or
needles should be used in order toextract 6 doses from a single vial. The
low dead-volume syringe and needle
combination should have a deadvolume of no more than
35 microlitres.

xx

0.3 mL diluted vaccinex

If standard syringes and needles areused, there may not be sufficientvolume to extract a sixth dose from asingle vial.
Each dose must contain 0.3 mL ofvaccine.
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 within
6 hours after dilution.

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

109

Package leaflet: Information for the user
Comirnaty 30 micrograms/dose dispersion for injection
Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified)tozinameranThis medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects you may get. See the end of section 4for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or nurse.
x
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.
What is in this leaflet
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.
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 Comirnaty

Comirnaty should not be givenx
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:xyou have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
x
you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
x
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.
x
you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.

110

x

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 maintainphysical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinatedas appropriate. Discuss appropriate individual recommendations with your doctor.
ChildrenComirnaty 30 micrograms/dose dispersion for injection is not recommended for children aged under
12 years.
There is a paediatric presentation available for children 5 to 11 years of age. For details, please refer tothe WHO Package Leaflet for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
Other medicines and Comirnaty
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicinesor have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you
receive 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 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 tocomplete the vaccination course.

111

A booster dose (third dose) of Comirnaty may be given at least 6 months after the second dose inindividuals 12 years of age and older.
If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after thesecond 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 peoplex
injection site: pain, swellingx
tirednessxheadachex
muscle painxchillsx
joint painx
diarrhoeaxfeverSome 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 peoplex
injection site rednessxnauseax
vomiting
Uncommon side effects: may affect up to 1 in 100 peoplexenlarged lymph nodes (more frequently observed after the booster dose)x
feeling unwellx
arm painx
insomniax
injection site itchingx
allergic reactions such as rash or itchingx
feeling weak or lack of energy/sleepyxdecreased appetitex
excessive sweatingxnight sweats
Rare side effects: may affect up to 1 in 1,000 peoplex
temporary one sided facial droopingx
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 peoplex
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)x
severe allergic reactionx
extensive swelling of the vaccinated limbxswelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)
112

x
x
x

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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system 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

The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
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.
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
6 hours.
Once removed from the freezer, the unopened vial may be stored and transported refrigerated at 2 °C
to 8 °C up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should bemarked 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.
Once the vaccine vial is punctured it should be used immediately or within 6 hours and kept at 2 °C to
8 °C. 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 tothrow away medicines you no longer use. These measures will help protect the environment.

113

6.

Contents of the pack and other information

What Comirnaty containsx
The active substance is COVID-19 mRNA Vaccine called tozinameran. The vial contains
6 doses of 0.3 mL with 30 micrograms tozinameran each.
x
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 packThe 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.
Manufacturer
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.deThis leaflet was last revised in {MM/YYYY}
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com-----------------------------------------------------------------------------------------------------------------------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 inindividuals 12 years of age and older.

114

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 numberof the administered product should be clearly recorded.
Handling instructions
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure thesterility of the prepared dispersion.
VIAL VERIFICATION OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSION FOR
INJECTION (12 YEARS AND OLDER)
x Verify that the vial has a grey plastic
cap and a grey border around the label
and the product name is Comirnaty
Grey cap
30 micrograms/dose dispersion for
injection.
x If the vial has a purple plastic cap,
please make reference to the WHO
Product Information for Comirnaty
30 micrograms/dose concentrate fordispersion for injection.
x If the vial has an orange plastic cap,
please make reference to the WHO
Product Information for Comirnaty
10 micrograms/dose concentrate fordispersion for injection.

115

HANDLING PRIOR TO USE OF COMIRNATY 30 MICROGRAMS/DOSE DISPERSIONFOR INJECTION (12 YEARS AND OLDER)
x 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
Store for up toprior to use.
10 weeks atxUpon moving vials to 2 °C to 8 °C
2 °C to 8 °C,
storage, update the expiry date on the
update the expiry
carton.
on the carton.
x Unopened vials can be stored for up to
10 weeks at 2 °C to 8 °C; notexceeding the printed expiry date
(EXP).
x Thawed vials can be handled in room
light conditions.
x Gently mix by inverting vials 10 times
prior to use. Do not shake.
x Prior to mixing, the thawed dispersion
may contain white to off-white opaqueamorphous particles.
x After mixing, the vaccine shouldpresent as a white to off-white
dispersion with no particulates visible.
Do not use the vaccine if particulates
or discolouration are present.

Gently × 10

116

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
30 MICROGRAMS/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x Using aseptic technique, cleanse thevial stopper with a single-use
antiseptic swab.
x Withdraw 0.3 mL of Comirnaty.
Low dead-volume syringes and/or
needles should be used in order toextract 6 doses from a single vial. The
low dead-volume syringe and needle
combination should have a deadvolume of no more than
35 microlitres.

xx
0.3 mL vaccinex

If standard syringes and needles areused, there may not be sufficientvolume to extract a sixth dose from asingle vial.
Each dose must contain 0.3 mL ofvaccine.
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 6 hours
after first puncture. Record theappropriate date/time on the vial.

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

117

Package leaflet: Information for the user
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection
Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified)tozinameran/riltozinameranThis medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects you may get. See the end of section 4for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or nurse.
x
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.
What is in this leaflet
1. What Comirnaty Original/Omicron BA.1 is and what it is used for
2. What you need to know before you receive 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 for preventing COVID-19 caused by
SARS-CoV-2. It is given to adults and adolescents from 12 years of age and older.
Comirnaty Original/Omicron BA.1 is only for individuals who have previously received at least a
primary vaccination course against COVID-19.
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 Original/Omicron BA.1 does not contain the virus to produce immunity, it cannot give
you COVID-19.
2.

What you need to know before you receive Comirnaty Original/Omicron BA.1

Comirnaty Original/Omicron BA.1 should not be givenx
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:xyou have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
x
you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
x
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.
127

x
x

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 Original/Omicron BA.1 may not fully protect all those who receive it
and it is not known how long you will be protected.
The efficacy of Comirnaty Original/Omicron BA.1 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. Discussappropriate individual recommendations with your doctor.
ChildrenComirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection is notrecommended for children aged under 12 years.
Other medicines and Comirnaty Original/Omicron BA.1
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicinesor have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you
receive this vaccine.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.1 during pregnancy.
However, a large amount of information from pregnant women vaccinated with the initially approved
Comirnaty vaccine 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 Original/Omicron BA.1 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.1 during
breast-feeding. However, no effects on the breast-fed newborn/infant are anticipated. Data fromwomen who were breast-feeding after vaccination with the initially approved Comirnaty vaccine havenot shown a risk for adverse effects in breast-fed newborns/infants. Comirnaty Original/Omicron BA.1
can be used while 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 drive or use machines. Wait until these effects have worn off before you drive or
use machines.
3.

How Comirnaty Original/Omicron BA.1 is given

Comirnaty Original/Omicron BA.1 is given as an injection of 0.3 mL into a muscle of your upper arm.
Comirnaty Original/Omicron BA.1 may be given at least 3 months after the most recent dose of a
COVID-19 vaccine.

128

Comirnaty Original/Omicron BA.1 is only indicated for individuals who have previously received atleast a primary vaccination course against COVID-19.
Please check with your healthcare provider regarding eligibility for and timing of the booster dose.
For details on the primary vaccination course in individuals 12 years of age and older, please see the
Package Leaflet for Comirnaty 30 micrograms/dose dispersion for injection or Comirnaty
30 micrograms/dose concentrate for dispersion for injection.
If you have any further questions on the use of Comirnaty Original/Omicron BA.1, ask your doctor,
pharmacist or nurse.
4.

Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.1 can cause side effects, although not everybody
gets them.
Very common side effects: may affect more than 1 in 10 peoplex
injection site: pain, swellingx
tirednessxheadachex
muscle painxchillsx
joint painx
diarrhoeaxfeverSome 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 peoplex
injection site rednessxnauseax
vomiting
Uncommon side effects: may affect up to 1 in 100 peoplexenlarged lymph nodes (more frequently observed after the booster dose)x
feeling unwellx
arm painx
insomniax
injection site itchingx
allergic reactions such as rash or itchingx
feeling weak or lack of energy/sleepyxdecreased appetitex
excessive sweatingxnight sweats
Rare side effects: may affect up to 1 in 1,000 peoplex
temporary one sided facial droopingx
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 peoplex
inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart(pericarditis) which can result in breathlessness, palpitations or chest pain

129Not known (cannot be estimated from the available data)x
severe allergic reactionx
extensive swelling of the vaccinated limbxswelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)xa 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)x
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)xdecreased feeling or sensitivity, especially in the skin (hypoaesthesia)
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. You can also report side effects directly via the national reporting
system listed in Appendix V 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 Original/Omicron BA.1

The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
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.
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
6 hours.
Once removed from the freezer, the unopened vial may be stored and transported refrigerated at 2 °C
to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should bemarked 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.
Once the vaccine vial is punctured it should be used immediately or within 6 hours and kept at 2 °C to
8 °C. 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 tothrow away medicines you no longer use. These measures will help protect the environment.

130

6.

Contents of the pack and other information

What Comirnaty Original/Omicron BA.1 containsx
The active substance is COVID-19 mRNA Vaccine called tozinameran/riltozinameran. The vial
contains 6 doses of 0.3 mL with 15 micrograms of tozinameran and 15 micrograms ofriltozinameran (Omicron BA.1) per dose.
x
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 Original/Omicron BA.1 looks like and contents of the packThe 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.
Manufacturer
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.deThis leaflet was last revised in {MM/YYYY}
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
The dose of Comirnaty Original/Omicron BA.1 is 0.3 mL given intramuscularly.
There should be an interval of at least 3 months between administration of Comirnaty
Original/Omicron BA.1 and the last prior dose of a COVID-19 vaccine.

131Comirnaty Original/Omicron BA.1 is only indicated for individuals who have previously received atleast a primary vaccination course against COVID-19.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch numberof the administered product should be clearly recorded.
Handling instructions
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
Comirnaty Omicron/Omicron BA.1 should be prepared by a healthcare professional using aseptic
technique to ensure the sterility of the prepared dispersion.
VIAL VERIFICATION OF COMIRNATY ORIGINAL/OMICRON BA.1
(15/15 MICROGRAMS)/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x Verify that the vial has a grey plastic
cap and a grey border around the label
and the product name is Comirnaty
Original/Omicron BA.1
(15/15 micrograms)/dose dispersion
for injection.
x If the vial has a grey plastic cap and a
Grey capgrey border and the product name isComirnaty 30 micrograms/dose
dispersion for injection, please makeComirnatyreference to the WHO ProductOriginal/
Information for this formulation.
Omicron BA.1
x If the vial has a purple plastic cap,
please make reference to the WHO
Do not dilute
Product Information for Comirnaty
30 micrograms/dose concentrate fordispersion for injection.
x If the vial has an orange plastic cap,
please make reference to the WHO
Product Information for Comirnaty
10 micrograms/dose concentrate fordispersion for injection.

132

HANDLING PRIOR TO USE OF COMIRNATY ORIGINAL/OMICRON BA.1
(15/15 MICROGRAMS)/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x 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; aStore for up to
10 vial pack may take 6 hours to thaw.
10 weeks at 2 °C to
Ensure vials are completely thawed
8 °C, update theprior to use.
expiry on the carton.
x Upon moving vials to 2 °C to 8 °C
storage, update the expiry date on the
carton.
x Unopened vials can be stored for up to
10 weeks at 2 °C to 8 °C; notexceeding the printed expiry date
(EXP).
x Thawed vials can be handled in room
light conditions.
x Gently mix by inverting vials 10 times
prior to use. Do not shake.
x Prior to mixing, the thawed dispersion
may contain white to off-white opaqueamorphous particles.
x After mixing, the vaccine shouldpresent as a white to off-white
dispersion with no particulates visible.
Do not use the vaccine if particulates
or discolouration are present.

Gently × 10

133

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATYORIGINAL/OMICRON BA.1 (15/15 MICROGRAMS)/DOSE DISPERSION FOR
INJECTION (12 YEARS AND OLDER)
x Using aseptic technique, cleanse thevial stopper with a single-use
antiseptic swab.
x Withdraw 0.3 mL of Comirnaty
Original/Omicron BA.1.
Low dead-volume syringes and/or
needles should be used in order toextract 6 doses from a single vial. The
low dead-volume syringe and needle
combination should have a deadvolume of no more than
35 microlitres.

xx
0.3 mL vaccinex

If standard syringes and needles areused, there may not be sufficientvolume to extract a sixth dose from asingle vial.
Each dose must contain 0.3 mL ofvaccine.
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 6 hours
after first puncture. Record theappropriate date/time on the vial.

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

134

Package leaflet: Information for the user
Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection
Adults and adolescents from 12 years
COVID-19 mRNA Vaccine (nucleoside modified)tozinameran/famtozinameranThis medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects you may get. See the end of section 4for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor, pharmacist or nurse.
x
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.
What is in this leaflet
1. What Comirnaty Original/Omicron BA.4-5 is and what it is used for
2. What you need to know before you receive Comirnaty Original/Omicron BA.4-5
3. How Comirnaty Original/Omicron BA.4-5 is given
4. Possible side effects
5. How to store Comirnaty Original/Omicron BA.4-5
6. Contents of the pack and other information
1.

What Comirnaty Original/Omicron BA.4-5 is and what it is used for

Comirnaty Original/Omicron BA.4-5 is a vaccine used for preventing COVID-19 caused by
SARS-CoV-2. It is given to adults and adolescents from 12 years of age and older.
Comirnaty Original/Omicron BA.4-5 is only for individuals who have previously received at least a
primary vaccination course against COVID-19.
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 Original/Omicron BA.4-5 does not contain the virus to produce immunity, it cannot
give you COVID-19.
2.

What you need to know before you receive Comirnaty Original/Omicron BA.4-5

Comirnaty Original/Omicron BA.4-5 should not be givenx
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:xyou have ever had a severe allergic reaction or breathing problems after any other vaccine
injection or after you were given Comirnaty in the past.
x
you are feeling nervous about the vaccination process or have ever fainted following any needle
injection.
x
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.
135

x
x

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 Original/Omicron BA.4-5 may not fully protect all those who receive
it and it is not known how long you will be protected.
The efficacy of Comirnaty Original/Omicron BA.4-5 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. Discussappropriate individual recommendations with your doctor.
ChildrenComirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is notrecommended for children aged under 12 years.
Other medicines and Comirnaty Original/Omicron BA.4-5
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicinesor have recently received any other vaccine.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you
receive this vaccine.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.4-5 during pregnancy.
However, a large amount of information from pregnant women vaccinated with the initially approved
Comirnaty vaccine 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 Original/Omicron BA.4-5 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Original/Omicron BA.4-5 during
breast-feeding. However, no effects on the breast-fed newborn/infant are anticipated. Data fromwomen who were breast-feeding after vaccination with the initially approved Comirnaty vaccine havenot shown a risk for adverse effects in breastfed newborns/infants. Comirnaty Original/Omicron
BA.4-5 can be used while 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 drive or use machines. Wait until these effects have worn off before you drive or
use machines.
3.

How Comirnaty Original/Omicron BA.4-5 is given

Comirnaty Original/Omicron BA.4-5 is given as an injection of 0.3 mL into a muscle of your upperarm.
Comirnaty Original/Omicron BA.4-5 may be given at least 3 months after the most recent dose of a
COVID-19 vaccine.
136Comirnaty Original/Omicron BA.4-5 is only indicated for individuals who have previously received atleast a primary vaccination course against COVID-19.
Please check with your healthcare provider regarding eligibility for and timing of the booster dose.
For details on the primary vaccination course in individuals 12 years of age and older, please see the
Package Leaflet for Comirnaty 30 micrograms/dose dispersion for injection or Comirnaty
30 micrograms/dose concentrate for dispersion for injection.
If you have any further questions on the use of Comirnaty Original/Omicron BA.4-5, ask your doctor,
pharmacist or nurse.
4.

Possible side effects

Like all vaccines, Comirnaty Original/Omicron BA.4-5 can cause side effects, although not everybody
gets them.
Very common side effects: may affect more than 1 in 10 peoplex
injection site: pain, swellingx
tirednessxheadachex
muscle painxchillsx
joint painx
diarrhoeaxfeverSome 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 peoplex
injection site rednessxnauseax
vomiting
Uncommon side effects: may affect up to 1 in 100 peoplexenlarged lymph nodes (more frequently observed after the booster dose)x
feeling unwellx
arm painx
insomniax
injection site itchingx
allergic reactions such as rash or itchingx
feeling weak or lack of energy/sleepyxdecreased appetitex
excessive sweatingxnight sweats
Rare side effects: may affect up to 1 in 1,000 peoplex
temporary one sided facial droopingx
allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10,000 peoplex
inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart(pericarditis) which can result in breathlessness, palpitations or chest pain137

Not known (cannot be estimated from the available data)x
severe allergic reactionx
extensive swelling of the vaccinated limbxswelling of the face (swelling of the face may occur in patients who have had facial
dermatological fillers)xa 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)x
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)xdecreased feeling or sensitivity, especially in the skin (hypoaesthesia)
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. You can also report side effects directly via the national reporting
system listed in Appendix V 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 Original/Omicron BA.4-5

The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
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.
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
6 hours.
Once removed from the freezer, the unopened vial may be stored and transported refrigerated at 2 °C
to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should bemarked 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.
Once the vaccine vial is punctured it should be used immediately or within 6 hours and kept at 2 °C to
8 °C. 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 tothrow away medicines you no longer use. These measures will help protect the environment.

138

6.

Contents of the pack and other information

What Comirnaty Original/Omicron BA.4-5 containsx
The active substance is COVID-19 mRNA Vaccine called tozinameran/famtozinameran. The
vial contains 6 doses of 0.3 mL with 15 micrograms of tozinameran and 15 micrograms of
famtozinameran (Omicron BA.4-5) per dose.
x
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 Original/Omicron BA.4-5 looks like and contents of the packThe 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: 10 vials or 195 vials
Not all pack sizes may be marketed.
Manufacturer
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz
Germany
Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.deThis leaflet was last revised in {MM/YYYY}
Scan the code with a mobile device to get the package leaflet in different languages.

URL: www.comirnatyglobal.com-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
The dose of Comirnaty Original/Omicron BA.4-5 is 0.3 mL given intramuscularly.
There should be an interval of at least 3 months between administration of Comirnaty
Original/Omicron BA.4-5 and the last prior dose of a COVID-19 vaccine.
139Comirnaty Original/Omicron BA.4-5 is only indicated for individuals who have previously received atleast a primary vaccination course against COVID-19.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch numberof the administered product should be clearly recorded.
Handling instructions
The storage and handling conditions printed on the vial or carton labels may differ from those in thisproduct information. In these circumstances, the conditions in the product information should be
followed.
Comirnaty Original/Omicron BA.4-5 should be prepared by a healthcare professional using aseptic
technique to ensure the sterility of the prepared dispersion.

140

VIAL VERIFICATION OF COMIRNATY ORIGINAL/OMICRON BA.4-5(15/15 MICROGRAMS)/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x Verify that the vial has a grey plastic
cap and a grey border around the label
and the product name is Comirnaty
Grey cap
Original/Omicron BA.4-5(15/15 micrograms)/dose dispersion for
injection.
x
If
the vial has a grey plastic cap and a
Comirnaty
grey border and the product name is
Original/
Comirnaty 30 micrograms/dose
Omicron BA.4-5
dispersion for injection, please makereference to the WHO Summary of
Do not dilute
Product Characteristics for thisformulation.
x If the vial has a purple plastic cap,
please make reference to the WHO
Summary of Product Characteristics for
Comirnaty 30 micrograms/dose
concentrate for dispersion for injection.
x If the vial has an orange plastic cap,
please make reference to the WHO
Summary of Product Characteristics for
Comirnaty 10 micrograms/dose
concentrate for dispersion for injection.
HANDLING PRIOR TO USE OF COMIRNATY ORIGINAL/OMICRON BA.4-5(15/15 MICROGRAMS)/DOSE DISPERSION FOR INJECTION (12 YEARS AND OLDER)
x 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.
Store for up to
Ensure vials are completely thawed
10 weeks at 2 °C toprior to use.
8 °C, update expiry
x Upon moving vials to 2 °C to 8 °C
on carton.
storage, update the expiry date on the
carton.
x Unopened vials can be stored for up to
10 weeks at 2 °C to 8 °C; not exceeding
the printed expiry date (EXP).
x Thawed vials can be handled in room
light conditions.

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x
x
x

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 opaqueamorphous particles.
After mixing, the vaccine shouldpresent as a white to off-white
dispersion with no particulates visible.
Do not use the vaccine if particulates ordiscolouration are present.

Gently × 10
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATYORIGINAL/OMICRON BA.4-5 (15/15 MICROGRAMS)/DOSE DISPERSION FOR
INJECTION (12 YEARS AND OLDER)
x Using aseptic technique, cleanse thevial stopper with a single-use antisepticswab.
x Withdraw 0.3 mL of Comirnaty
Original/Omicron BA.4-5.
Low dead-volume syringes and/or
needles should be used in order toextract 6 doses from a single vial. The
low dead-volume syringe and needle
combination should have a deadvolume of no more than 35 microlitres.

xx
0.3 mL vaccinex

If standard syringes and needles areused, there may not be sufficientvolume to extract a sixth dose from asingle vial.
Each dose must contain 0.3 mL ofvaccine.
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 6 hours
after first puncture. Record theappropriate date/time on the vial.

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

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