Annex I Summary of Product Characteristics
Annex I Summary of Product Characteristics
1
This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6.
1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid
nanoparticles).
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription
from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus,
in individuals 16 years of age and older.
Posology
There are no data available on the interchangeability of Comirnaty with other COVID-19 vaccines to
complete the vaccination course. Individuals who have received 1 dose of Comirnaty should receive a
second dose of Comirnaty to complete the vaccination course.
Paediatric population
The safety and efficacy of Comirnaty in children and adolescents aged less than 16 years of age have
not yet been established. Limited data are available.
2
Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age.
Method of administration
After dilution, vials of Comirnaty contain six doses of 0.3 mL of vaccine. In order to extract six doses
from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume
syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard
syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single
vial. Irrespective of the type of syringe and needle:
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.
General recommendations
Close observation for at least 15 minutes is recommended following vaccination. A second dose of the
vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related
reactions may occur in association with vaccination as a psychogenic response to the needle injection.
It is important that precautions are in place to avoid injury from fainting.
3
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute
infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Immunocompromised individuals
The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised
individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be
lower in immunosuppressed individuals.
Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by
ongoing clinical trials.
Excipients
This 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’.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant administration of Comirnaty with other vaccines has not been studied.
Pregnancy
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate
direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or
post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be
considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
(see section 5.3).
4
4.7 Effects on ability to drive and use machines
Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of
the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
The safety of Comirnaty was evaluated in participants 16 years of age and older in 2 clinical studies
that included 21,744 participants that have received at least one dose of Comirnaty.
In Study 2, a total of 21,720 participants 16 years of age or older received at least 1 dose of Comirnaty
and a total of 21,728 participants 16 years of age or older received placebo (including 138 and
145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of
20,519 participants 16 years of age or older received 2 doses of Comirnaty.
At the time of the analysis of Study 2, a total of 19,067 (9,531 Comirnaty and 9,536 placebo)
participants 16 years of age or older were evaluated for safety for at least 2 months after the second
dose of Comirnaty. This included a total of 10,727 (5,350 Comirnaty and 5,377 placebo) participants
16 to 55 years of age and a total of 8,340 (4,181 Comirnaty and 4,159 placebo) participants 56 years
and older.
The most frequent adverse reactions in participants 16 years of age and older were injection site pain
(> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia
and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within
a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with
greater age.
Tabulated list of adverse reactions from clinical studies and post-authorisation experience
Adverse reactions observed during clinical studies are listed below according to the following
frequency categories:
5
Table 1: Adverse reactions from Comirnaty clinical trials and post-authorisation experience
Not known
Very Common Uncommon Rare (cannot be
System Organ
common (≥ 1/100 to (≥ 1/1,000 to (≥ 1/10,000 estimated from
Class
(≥ 1/10) < 1/10) < 1/100) to < 1/1,000) the available
data)
Blood and Lymphadenopathy
lymphatic
system disorders
Immune system Hypersensitivity Anaphylaxis
disorders reactions (e.g.
rash, pruritus,
urticaria,a
angioedemaa)
Psychiatric Insomnia
disorders
Nervous system Headache Acute
disorders peripheral
facial
paralysisb
Gastrointestinal Diarrhoeac Nausea;
disorders Vomitingc
Musculoskeletal Arthralgia; Pain in extremityd
and connective Myalgia
tissue disorders
General Injection Injection Malaise; Injection
disorders and site pain; site redness site pruritus
administration Fatigue;
site conditions Chills;
Pyrexia;e
Injection
site
swelling
a. The frequency category for urticaria and angioedema was Rare.
b. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or
palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after
Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral
facial paralysis (or palsy) were reported in the placebo group.
c. Adverse reaction determined post-authorisation.
d. Refers to vaccinated arm.
e. A higher frequency of pyrexia was observed after the second dose.
The safety profile in 545 subjects receiving Comirnaty, that were seropositive for SARS-CoV-2 at
baseline, was similar to that seen in the general population.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V and include batch/Lot number if available.
4.9 Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error
in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in
reactogenicity or adverse reactions.
6
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is
recommended.
5. PHARMACOLOGICAL PROPERTIES
Mechanism of action
Efficacy
In the Phase 2/3 portion, approximately 44,000 participants were randomised equally and were to
receive 2 doses of COVID-19 mRNA Vaccine or placebo separated by 21 days. The efficacy analyses
included participants that received their second vaccination within 19 to 42 days after their first
vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days
after Dose 1. Participants are planned to be followed for up to 24 months after Dose 2, for assessments
of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a
minimum interval of 14 days before and after administration of an influenza vaccine in order to
receive either placebo or COVID-19 mRNA Vaccine. In the clinical study, participants were required
to observe a minimum interval of 60 days before or after receipt of blood/plasma products or
immunoglobulins within through conclusion of the study in order to receive either placebo or
COVID-19 mRNA Vaccine.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years
of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group)
who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.
In addition, 134 participants were between the ages of 16 to 17 years of age (66 in the COVID-19
mRNA Vaccine group and 68 in the placebo group) and 1,616 participants 75 years of age and older
(804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group).
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Efficacy against COVID-19
At the time of the primary efficacy analysis, participants had been followed for symptomatic
COVID-19 for in total 2,214 person-years for the COVID-19 mRNA Vaccine and in total
2,222 person-years in the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at
risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe
COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes
mellitus, hypertension).
Table 2: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age
subgroup – participants without evidence of infection prior to 7 days after Dose 2 –
evaluable efficacy (7 days) population
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior
SARS-CoV-2 infection*
COVID-19 mRNA
Vaccine Placebo
a a
N = 18,198 N = 18,325
Cases Cases
n1b n1b Vaccine efficacy
c d
Subgroup Surveillance time (n2 ) Surveillance timec (n2d) % (95% CI)f
8 162
e
All subjects 2.214 (17,411) 2.222 (17,511) 95.0 (90.0, 97.9)
7 143
16 to 64 years 1.706 (13,549) 1.710 (13,618) 95.1 (89.6, 98.1)
1 19
65 years and older 0.508 (3848) 0.511 (3880) 94.7 (66.7, 99.9)
1 14
65 to 74 years 0.406 (3074) 0.406 (3095) 92.9 (53.1, 99.8)
0 5
75 years and older 0.102 (774) 0.106 (785) 100.0 (-13.1, 100.0)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and
at least 1 symptom consistent with COVID-19 [*Case definition: (at least 1 of) fever, new or increased cough,
new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore
throat, diarrhoea or vomiting.]
* Participants who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of
past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not
detected by nucleic acid amplification tests (NAAT) [nasal swab] at Visits 1 and 2), and had negative
NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
a. N = number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at
risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the
surveillance period.
d. n2 = Number of subjects at risk for the endpoint.
e. No confirmed cases were identified in participants 12 to 15 years of age.
f. Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted
to the surveillance time. CI not adjusted for multiplicity.
In the second primary analysis, efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19
occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% credible interval of 89.9%
to 97.3%) in participants 16 years of age and older with or without evidence of prior infection with
SARS-CoV-2.
8
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point
estimates across genders, ethnic groups, and participants with medical comorbidities associated with
high risk of severe COVID-19.
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with
Comirnaty in the paediatric population in prevention of COVID-19 (see section 4.2 for information on
paediatric use).
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This
means that further evidence on this medicinal product is awaited. The European Medicines Agency
will review new information on this medicinal product at least every year and this SmPC will be
updated as necessary.
Not applicable.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose
toxicity and reproductive and developmental toxicity.
General toxicity
Rats intramuscularly administered Comirnaty (receiving 3 full human doses once weekly, generating
relatively higher levels in rats due to body weight differences) demonstrated some injection site
oedema and erythema and increases in white blood cells (including basophils and eosinophils)
consistent with an inflammatory response as well as vacuolation of portal hepatocytes without
evidence of liver injury. All effects were reversible.
Genotoxicity/Carcinogenicity
Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids
and mRNA) are not expected to have genotoxic potential.
Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and
developmental toxicity study where female rats were intramuscularly administered Comirnaty prior to
mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat
due to body weight differences, spanning between pre-mating day 21 and gestational day 20).
SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating
to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no
vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No
Comirnaty data are available on vaccine placental transfer or excretion in milk.
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6. PHARMACEUTICAL PARTICULARS
((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
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in
section 6.6.
Unopened vial
Frozen vial
6 months at -90 °C to -60 °C
Within the 6 months shelf-life unopened vials may be stored and transported at -25 °C to -15 °C for a
single period of up to 2 weeks and can be returned to -90 °C to -60 °C.
Thawed vial
1 month at 2 °C to 8 °C
Within the 1-month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation.
Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C.
10
Transfers of frozen vials stored at -25 °C to -15 °C
• Closed-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.
• 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.
Chemical and physical in-use stability, including during transportation, has been demonstrated for
6 hours at 2 ºC to 30 ºC after dilution in sodium chloride 9 mg/mL (0.9%) solution for injection. From
a microbiological point of view, unless the method of dilution precludes the risk of microbial
contamination, the product should be used immediately. If not used immediately, in-use storage times
and conditions are the responsibility of the user.
For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a flip-off
plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.
Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the
sterility of the prepared dispersion.
11
THAWING PRIOR TO DILUTION
• The multidose vial is stored frozen and
must be thawed prior to dilution.
No more than Frozen vials should be transferred to an
2 hours at environment of 2 °C to 8 °C to thaw; a
195 vial pack may take 3 hours to thaw.
room Alternatively, frozen vials may also be
temperature thawed for 30 minutes at temperatures
(up to 30 °C). up to 30 °C for immediate use.
• The unopened vial can be stored for up
to 1 month at 2 °C to 8 °C. Within the
1-month shelf-life at 2 °C to 8 °C, up to
12 hours may be used for
transportation.
• Allow the thawed vial to come to room
temperature and gently invert it
10 times prior to dilution. Do not shake.
• Prior to dilution, the thawed dispersion
may contain white to off-white opaque
amorphous particles.
DILUTION
• The thawed vaccine must be diluted in
its original vial with 1.8 mL sodium
chloride 9 mg/mL (0.9%) solution for
injection, using a 21 gauge or narrower
needle and aseptic techniques.
12
• Equalise vial pressure before removing
the needle from the vial stopper by
withdrawing 1.8 mL air into the empty
diluent syringe.
Gently × 10
13
• The diluted vials should be marked
with the appropriate date and time.
• After dilution, store at 2 ºC to 30 ºC and
use within 6 hours, including any
transportation time.
• Do not freeze or shake the diluted
dispersion. If refrigerated, allow the
diluted dispersion to come to room
temperature prior to use.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
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7. MARKETING AUTHORISATION HOLDER
EU/1/20/1528/001
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.
15
ANNEX II
16
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Rentschler Biopharma SE
Erwin-Rentschler-Strasse 21
88471 Laupheim
Germany
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
In view of the declared Public Health Emergency of International Concern and in order to ensure early
supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control
testing conducted in the registered site(s) that are located in a third country. This exemption ceases to
be valid on 31 August 2021. Implementation of EU based batch control arrangements, including the
necessary variations to the terms of the marketing authorisation, has to be completed by
31 August 2021 at the latest, in line with the agreed plan for this transfer of testing. Progress reports
have to be submitted on 31 March 2021 and included in the annual renewal application.
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken
by a state laboratory or a laboratory designated for that purpose.
17
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION
The requirements for submission of PSURs for this medicinal product are set out in the list of
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
and any subsequent updates published on the European medicines web-portal.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within
6 months following authorisation.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the
marketing authorisation and any agreed subsequent updates of the RMP.
This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No
726/2004, the MAH shall complete, within the stated timeframe, the following measures:
In order to confirm the consistency of the finished product manufacturing March 2021
process, the MAH should provide additional validation data.
In order to confirm the purity profile and ensure comprehensive quality control July 2021.
and batch-to-batch consistency throughout the lifecycle of the finished product, Interim reports:
the MAH should provide additional information about the synthetic process and January 2021,
control strategy for the excipient ALC-0315. April 2021
18
Description Due date
In order to confirm the purity profile and ensure comprehensive quality control July 2021.
and batch-to-batch consistency throughout the lifecycle of the finished product, Interim reports:
the MAH should provide additional information about the synthetic process and January 2021,
control strategy for the excipient ALC-0159. April 2021
In order to confirm the efficacy and safety of Comirnaty, the MAH should December 2023
submit the final Clinical Study Report for the randomized, placebo-controlled,
observer-blind study C4591001.
19
ANNEX III
20
A. LABELLING
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
3. LIST OF EXCIPIENTS
Dilute before use: Dilute each vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for
injection.
8. EXPIRY DATE
EXP
Expiry date at 2 °C to 8 °C: ……………..
(maximum 1 month; make former expiry date unreadable)
22
9. SPECIAL STORAGE CONDITIONS
Storage:
Prior to dilution, store at -90 °C to -60 °C in the original package in order to protect from light.
After dilution, store the vaccine at 2 °C to 30 °C and use within 6 hours. Discard any unused vaccine.
EU/1/20/1528/001
LOT
PC
SN
NN
23
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
VIAL LABEL
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
LOT
6. OTHER
Discard date/time:
24
B. PACKAGE LEAFLET
25
Package leaflet: Information for the user
This medicine is subject to additional monitoring. This will allow quick identification of new
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.
Read all of this leaflet carefully before you receive this vaccine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
Comirnaty is given to adults and adolescents from 16 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.
As with any vaccine, the 2-dose vaccination course of Comirnaty may not fully protect all those who
receive it and it is not known how long you will be protected.
26
Children and adolescents
Comirnaty is not recommended for children aged under 16 years.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially
‘sodium-free’.
Comirnaty is given after dilution as an injection of 0.3 mL into a muscle of your upper arm.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to
complete the vaccination course.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
27
Uncommon side effects: may affect up to 1 in 100 people
• enlarged lymph nodes
• feeling unwell
• arm pain
• insomnia
• injection site itching
• allergic reactions such as rash or itching
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. Within the 6 months shelf-life unopened vials may be stored and
transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C
to -60 °C.
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
28
1 month at 2 °C to 8 °C. Within the 1-month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for
transportation. Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to
30 °C.
After dilution, store and transport the vaccine at 2 °C to 30 °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 and
time. 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 to
throw away medicines you no longer use. These measures will help protect the environment.
Manufacturers
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
29
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer S.A./N.V. Tel. +370 52 51 4000
Tél/Tel: +32 (0)2 554 62 11
България Magyarország
Пфайзер Люксембург САРЛ, Клон Pfizer Kft
България Tel: +36 1 488 3700
Teл: +359 2 970 4333
Danmark Norge
Pfizer ApS Pfizer AS
Tlf: +45 44 201 100 Tlf: +47 67 526 100
Deutschland Nederland
BioNTech Manufacturing GmbH Pfizer BV
Tel: +49 6131 90840 Tel: +31 (0)10 406 43 01
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ.: +30 210 6785 800 Tel.: +48 22 335 61 00
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Télf:+34914909900 Tel: +351 21 423 5500
France România
Pfizer Pfizer Romania S.R.L
Tél +33 1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0) 1 52 11 400
30
Ísland Suomi/Finland
Icepharma hf Pfizer Oy
Simi: +354 540 8000 Puh/Tel: +358 (0)9 430 040
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: +371 670 35 775
This medicine has been given ‘conditional approval’. This means that there is more evidence to come
about this medicine. The European Medicines Agency will review new information on this medicine
at least every year and this leaflet will be updated as necessary.
Scan the code with a mobile device to get the package leaflet in different languages.
URL: www.comirnatyglobal.com
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.
This package leaflet is available in all EU/EEA languages on the European Medicines Agency
website.
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Administer Comirnaty intramuscularly after dilution as a course of 2 doses (0.3 mL each) 3 weeks
apart.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.
Handling instructions
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the
sterility of the prepared dispersion.
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THAWING PRIOR TO DILUTION
• The multidose vial is stored frozen and
must be thawed prior to dilution.
No more than Frozen vials should be transferred to an
2 hours at environment of 2 °C to 8 °C to thaw; a
195 vial pack may take 3 hours to thaw.
room Alternatively, frozen vials may also be
temperature thawed for 30 minutes at temperatures
(up to 30 °C). up to 30 °C for immediate use.
• The unopened vial can be stored for up
to 1 month at 2 °C to 8 °C. Within the
1-month shelf-life at 2 °C to 8 °C, up to
12 hours may be used for
transportation.
• Allow the thawed vial to come to room
temperature and gently invert it
10 times prior to dilution. Do not shake.
• Prior to dilution, the thawed dispersion
may contain white to off-white opaque
amorphous particles.
DILUTION
• The thawed vaccine must be diluted in
its original vial with 1.8 mL sodium
chloride 9 mg/mL (0.9%) solution for
injection, using a 21 gauge or narrower
needle and aseptic techniques.
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• Equalise vial pressure before removing
the needle from the vial stopper by
withdrawing 1.8 mL air into the empty
diluent syringe.
Gently × 10
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• The diluted vials should be marked
with the appropriate date and time.
• After dilution, store at 2 ºC to 30 ºC and
use within 6 hours, including any
transportation time.
• Do not freeze or shake the diluted
dispersion. If refrigerated, allow the
diluted dispersion to come to room
temperature prior to use.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
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