Comirnaty
ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 

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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.  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Comirnaty concentrate for dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
This is a multidose vial and must be diluted before use.  
 
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. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Concentrate for dispersion for injection (sterile concentrate). 
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, 
in individuals 16 years of age and older.  
 
The use of this vaccine should be in accordance with official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
 
Individuals 16 years of age and older 
Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each) at least 
21 days apart (see sections 4.4 and 5.1). 
 
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. 

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Elderly population 
No dosage adjustment is required in elderly individuals ≥ 65 years of age. 
 
Method of administration 
 
Comirnaty should be administered intramuscularly after dilution (see section 6.6).  
 
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: 
 
• Each dose must contain 0.3 mL of vaccine.   
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the 

vial and any excess volume.  
• Do not pool excess vaccine from multiple vials. 

 
The preferred site is the deltoid muscle of the upper arm. 
 
Do not inject the vaccine intravascularly, subcutaneously or intradermally.  
 
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. 
 
4.4 Special warnings and precautions for use 
 
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 
 
Hypersensitivity and anaphylaxis 
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should 
always be readily available in case of an anaphylactic reaction following the administration of the 
vaccine.  
 
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. 
 

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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. 
 
Thrombocytopenia and coagulation disorders 
As with other intramuscular injections, the vaccine should be given with caution in individuals 
receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as 
haemophilia) because bleeding or bruising may occur following an intramuscular administration in 
these individuals. 
 
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. 
 
Limitations of vaccine effectiveness 
As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals 
may not be fully protected until 7 days after their second dose of vaccine. 
 
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 
 
No interaction studies have been performed. 
 
Concomitant administration of Comirnaty with other vaccines has not been studied. 
 
4.6 Fertility, pregnancy and lactation 
 
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 
 
It is unknown whether Comirnaty is excreted in human milk.  
 
Fertility 
 
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3). 
 

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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. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
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 
 
Adverse reactions observed during clinical studies are listed below according to the following 
frequency categories:  
 
Very common (≥ 1/10),  
Common (≥ 1/100 to < 1/10),  
Uncommon (≥ 1/1,000 to < 1/100),  
Rare (≥ 1/10,000 to < 1/1,000),  
Very rare (< 1/10,000),  
Not known (cannot be estimated from the available data). 
 
Table 1: Adverse reactions from Comirnaty clinical trials 

System Organ 
Class 

Very 
common 
(≥ 1/10) 

Common 
(≥ 1/100 to 

< 1/10) 

Uncommon 
(≥ 1/1,000 to 

< 1/100) 

Rare 
(≥ 1/10,000 

to < 1/1,000) 

Not known 
(cannot be 

estimated from 
the available 

data) 
Blood and 
lymphatic 
system disorders 

  Lymphadenopathy   

Immune system 
disorders 

    Anaphylaxis; 
hypersensitivity 

Psychiatric 
disorders 

  Insomnia   

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System Organ 
Class 

Very 
common 
(≥ 1/10) 

Common 
(≥ 1/100 to 

< 1/10) 

Uncommon 
(≥ 1/1,000 to 

< 1/100) 

Rare 
(≥ 1/10,000 

to < 1/1,000) 

Not known 
(cannot be 

estimated from 
the available 

data) 
Nervous system 
disorders 

Headache   Acute 
peripheral 
facial 
paralysis† 

 

Gastrointestinal 
disorders 

 Nausea    

Musculoskeletal 
and connective 
tissue disorders 

Arthralgia; 
myalgia 

 Pain in extremity   

General 
disorders and 
administration 
site conditions 

Injection 
site pain; 
fatigue; 
chills; 
pyrexia*; 
injection 
site 
swelling 

Injection 
site redness 

Malaise; injection 
site pruritus 

  

* A higher frequency of pyrexia was observed after the 2nd dose. 
† Throughout the safety follow-up period to date, 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. 

 
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 of suspected adverse reactions 
 
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.  
 
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is 
recommended. 
 
 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03 
 
Mechanism of action 
 
The nucleoside-modified messenger RNA in Comirnaty is formulated in lipid nanoparticles, which 
enable delivery of the non replicating RNA into host cells to direct transient expression of the 
SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point 
mutations within the central helix. Mutation of these two amino acids to proline locks S in an 
antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and 
cellular immune responses to the spike (S) antigen, which may contribute to protection against 
COVID-19. 
 
Efficacy 
 
Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind 
dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. 
Randomisation was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 
56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study 
excluded participants who were immunocompromised and those who had previous clinical or 
microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as 
disease not requiring significant change in therapy or hospitalization for worsening disease during the 
6 weeks before enrolment, were included as were participants with known stable infection with human 
immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). At the time of the 
analysis of Study 2, information presented is based on participants 16 years and older. 
 
Efficacy in participants 16 years of age and older 
 
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. 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 1616 participants 75 years of age and older 
(804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group). 
 
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 

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COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m2, chronic pulmonary disease, diabetes 
mellitus, hypertension). 
 
The vaccine efficacy information is presented in Table 2. 
 
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* 

Subgroup 

COVID-19 mRNA 
Vaccine 

Na = 18,198 
Cases 

n1b 
Surveillance timec (n2d) 

Placebo 
 

Na = 18,325 
Cases 

n1b 
Surveillance timec (n2d) 

Vaccine efficacy 
% (95% CI)f 

  All subjectse 8 
2.214 (17,411) 

162 
2.222 (17,511) 95.0 (90.0, 97.9) 

  16 to 64 years 7 
1.706 (13,549) 

143 
1.710 (13,618) 95.1 (89.6, 98.1) 

  65 years and older 1 
0.508 (3848) 

19 
0.511 (3880) 94.7 (66.7, 99.9) 

  65 to 74 years 1 
0.406 (3074) 

14 
0.406 (3095) 92.9 (53.1, 99.8) 

  75 years and older 0 
0.102 (774)  

5 
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, compared to placebo, efficacy of COVID-19 mRNA Vaccine in 
participants from first COVID-19 occurrence from 7 days after Dose 2 compared to participants with 
or without evidence of prior infection with SARS-CoV-2 was 94.6% (95% credible interval of 89.9% 
to 97.3%) in participants 16 years of age and older.  
 
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.  
 

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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. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
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. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
((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 

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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.  
 
6.3 Shelf life 
 
Unopened vial 
 
6 months at -90 °C to -60 °C. 
 
Once removed from the freezer, the unopened vaccine can be stored for up to 5 days at 2 °C to 8 °C, 
and up to 2 hours at temperatures up to 30 °C, prior to use. 
 
Once thawed, the vaccine should not be re-frozen. 
 
Closed-lid vial trays containing 195 vials removed from frozen storage (< -60 °C) may be at room 
temperature (< 25 °C) for up to 5 minutes for transfer between ultra-low-temperature environments. 
After vial trays are returned to frozen storage following room temperature exposure, they must remain 
in frozen storage for at least 2 hours before they can be removed again. 
 
Diluted medicinal product 
 
Chemical and physical in-use stability 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, the 
product should be used immediately. If not used immediately, in-use storage times and conditions are 
the responsibility of the user. 
  
6.4 Special precautions for storage 
 
Store in a freezer at -90 °C to -60 °C. 
Store in the original package in order to protect from light. 
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet 
light.  
Thawed vials can be handled in room light conditions. 
 
When you are ready to thaw or use the vaccine 
• Open-lid vial trays, or vial trays containing less than 195 vials removed from frozen storage 

(< -60 °C) may be at room temperature (< 25 °C) for up to 3 minutes to remove vials or for 
transfer between ultra-low-temperature environments. 

• Once a vial is removed from the vial tray, it should be thawed for use. 
• After vial trays are returned to frozen storage following room temperature exposure, they must 

remain in frozen storage for at least 2 hours before they can be removed again. 
 

For storage conditions after thawing and dilution of the medicinal product, see section 6.3.  
 
6.5 Nature and contents of container 
 
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. 
 
Pack size: 195 vials 

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6.6 Special precautions for disposal and other handling 
 
Handling instructions 
 
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the 
sterility of the prepared dispersion. 

 
THAWING PRIOR TO DILUTION 

 
 

• The multidose vial is stored frozen and 
must be thawed prior to dilution. 
Frozen vials should be transferred to an 
environment of 2 °C to 8 °C to thaw; a 
195 vial pack may take 3 hours to thaw. 
Alternatively, frozen vials may also be 
thawed for 30 minutes at temperatures 
up to 30 °C for immediate use. 

• 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.  

No more than 
2 hours at 

room 
temperature 
(up to 30 °C) 

1.8 mL of 0.9% sodium chloride 
injection 

11 



 
 

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

 
 

• Gently invert the diluted dispersion 
10 times. Do not shake. 

• The diluted vaccine should present as 
an off-white dispersion with no 
particulates visible. Discard the diluted 
vaccine if particulates or discolouration 
are present. 

 

Pull back plunger to 1.8 mL to 
remove air from vial 

Gently x 10 

12 



 
 

• The diluted vials should be marked 
with the appropriate date and time. 

• Do not freeze or shake the diluted 
dispersion. If refrigerated, allow the 
diluted dispersion to come to room 
temperature prior to use. 
 

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY 

 
 

• After dilution, the vial contains 
2.25 mL from which 6 doses of 0.3 mL 
can be extracted.  

• Using aseptic technique, cleanse the 
vial stopper with a single-use antiseptic 
swab. 

• Withdraw 0.3 mL of Comirnaty. 
 

Low dead-volume syringes and/or 
needles should be used in order to 
extract 6 doses from a single vial. The 
low dead-volume syringe and needle 
combination should have a dead 
volume of no more than 35 microlitres. 
 
If standard syringes and needles are 
used, there may not be sufficient 
volume to extract a sixth dose from a 
single vial. 

• Each dose must contain 0.3 mL of 
vaccine. 

• If the amount of vaccine remaining in 
the vial cannot provide a full dose of 
0.3 mL, discard the vial and any excess 
volume. 

• Discard any unused vaccine within 
6 hours after dilution. 

 
 

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

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

0.3 mL diluted  
vaccine 

13 



7. MARKETING AUTHORISATION HOLDER 
 
BioNTech Manufacturing GmbH 
An der Goldgrube 12 
55131 Mainz 
Germany 
Phone: +49 6131 90840 
Fax: +49 6131 9084390 
info@biontech.de 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1528 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 December 2020 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 
  

14 

http://www.ema.europa.eu/


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 

ANNEX II 
 

A.  MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCES AND MANUFACTURERS RESPONSIBLE 
FOR BATCH RELEASE 

 
B.  CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
E.  SPECIFIC OBLIGATION TO COMPLETE 

POST-AUTHORISATION MEASURES FOR THE 
CONDITIONAL MARKETING AUTHORISATION 

15 



A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance(s) 
 
BioNTech Manufacturing GmbH  
An der Goldgrube 12  
55131 Mainz 
Germany 
 
Rentschler Biopharma SE 
Erwin-Rentschler-Strasse 21 
88471 Laupheim 
Germany 
 
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC  
1 Burtt Road 
Andover, MA 01810 
USA 
 
Name and address of the manufacturers responsible for batch release 
 
BioNTech Manufacturing GmbH 
Kupferbergterrasse 17 - 19 
55116 Mainz 
Germany  
 
Pfizer Manufacturing Belgium NV  
Rijksweg 12  
2870 Puurs  
Belgium 
 
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. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
• Official batch release 
 
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. 
 
 

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C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
• Periodic safety update reports (PSURs) 
 
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.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 

 
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. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 
 
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: 
 

Description Due date 
In order to complete the characterisation of the active substance and finished 
product, the MAH should provide additional data.  

July 2021. 
Interim reports: 
31 March 2021 

In order to ensure consistent product quality, the MAH should provide 
additional information to enhance the control strategy, including the active 
substance and finished product specifications. 
 

July 2021. 
Interim reports: 
March 2021 

In order to confirm the consistency of the finished product manufacturing 
process, the MAH should provide additional validation data. 
 

March 2021 

In order to confirm the purity profile and ensure comprehensive quality control 
and batch-to-batch consistency throughout the lifecycle of the finished product, 
the MAH should provide additional information about the synthetic process and 
control strategy for the excipient ALC-0315. 
 

July 2021. 
Interim reports: 
January 2021, 
April 2021 

In order to confirm the purity profile and ensure comprehensive quality control 
and batch-to-batch consistency throughout the lifecycle of the finished product, 
the MAH should provide additional information about the synthetic process and 
control strategy for the excipient ALC-0159. 
 

July 2021. 
Interim reports: 
January 2021, 
April 2021 

17 



Description Due date 
In order to confirm the efficacy and safety of Comirnaty, the MAH should 
submit the final Clinical Study Report for the randomized, placebo-controlled, 
observer-blind study C4591001. 
 

December 2023 

  

18 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  

19 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  

20 



PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON BOX LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
COMIRNATY concentrate for dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After dilution each vial contains 6 doses of 0.3 mL. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: ALC-0315, ALC-0159, DSPC, cholesterol, potassium chloride, potassium dihydrogen 
phosphate, sodium chloride, disodium phosphate dihydrate, sucrose, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Concentrate for dispersion for injection 
195 multidose vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use after dilution. 
Read the package leaflet before use.  
 
Scan QR code for more information. 
 
Dilute before use: Dilute each vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for 
injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 

21 



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. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
BioNTech Manufacturing GmbH 
An der Goldgrube 12 
55131 Mainz, Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1528 
 
 
13. BATCH NUMBER 
 
LOT 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  

22 



MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
COMIRNATY sterile concentrate 
COVID-19 mRNA Vaccine 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
LOT 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
6 doses after dilution 
 
 
6. OTHER 
 
Discard date/time: 
 
 
  

23 



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 

24 



Package leaflet: Information for the user 
 

Comirnaty concentrate for dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 

 
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. 
 
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 virus.  
 
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. 
 
 
2. What you need to know before you receive Comirnaty  
 
Comirnaty should not be given 
• if you are allergic to the active substance or any of the other ingredients of this medicine (listed 

in section 6)  
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before you are given the vaccine if: 
• you have ever had a severe allergic reaction or breathing problems after any other vaccine 

injection or after you were given Comirnaty in the past. 
• you have ever fainted following any needle injection. 
• you have a severe illness or infection with high fever. However, you can have your vaccination 

if you have a mild fever or upper airway infection like a cold. 
• you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots. 
• you have a weakened immune system, because of a disease such as HIV infection or a medicine 

such as corticosteroid that affects your immune system 
 
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. 

25 



 
Children and adolescents 
Comirnaty is not recommended for children aged under 16 years. 
 
Other medicines and Comirnaty 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines 
or have recently received any other vaccine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before you receive this vaccine. 
 
Driving and using machines 
Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily 
affect your ability to drive or use machines. Wait until these effects have worn off before you drive or 
use machines. 
 
Comirnaty contains potassium and sodium 
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’. 
 
 
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, given at least 21 days apart. 
 
After the first dose of Comirnaty, you should receive a second dose of the same vaccine after 21 days 
to complete the vaccination course.  
 
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them. 
 
Very common side effects: may affect more than 1 in 10 people 
• injection site: pain, swelling  
• tiredness 
• headache 
• muscle pain  
• joint pain 
• chills, fever 
 
Common side effects: may affect up to 1 in 10 people 
• injection site redness  
• nausea 
 

26 



Uncommon side effects: may affect up to 1 in 100 people 
• enlarged lymph nodes 
• feeling unwell 
• pain in limb 
• insomnia 
• injection site itching 
 
Rare side effects: may affect up to 1 in 1,000 people 
• temporary one sided facial drooping 
 
Not known (cannot be estimated from the available data)  
• severe allergic reaction  
 
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 
 
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. 
 
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 
5 days at 2 °C to 8 °C, or up to 2 hours at temperatures up to 30 °C, prior to use. 
 
After dilution, store 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. 
 
 

27 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


6. Contents of the pack and other information 
 
What Comirnaty contains  
• The active substance is COVID-19 mRNA Vaccine. After dilution, the vial contains 6 doses 

of 0.3 mL with 30 micrograms mRNA each. 
• The other ingredients are:  

− ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 
− 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) 
− 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) 
− cholesterol 
− potassium chloride 
− potassium dihydrogen phosphate 
− sodium chloride 
− disodium phosphate dihydrate 
− sucrose 
− water for injections 

 
What Comirnaty looks like and contents of the pack 
The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 6 doses in 
a 2 mL clear vial (type I glass), with a rubber stopper and a flip-off plastic cap with aluminium seal. 
 
Pack size: 195 vials 
  
Marketing Authorisation Holder 
BioNTech Manufacturing GmbH 
An der Goldgrube 12 
55131 Mainz 
Germany 
Phone: +49 6131 90840 
Fax: +49 6131 9084390 
info@biontech.de 
 
Manufacturers 
BioNTech Manufacturing GmbH 
Kupferbergterrasse 17 - 19 
55116 Mainz 
Germany  
 
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 
Luxembourg/Luxemburg  
Pfizer S.A./N.V. 
Tél/Tel: +32 (0)2 554 62 11 
 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. +370 52 51 4000 
 

България 
Пфайзер Люксембург САРЛ, Клон 
България 
Teл: +359 2 970 4333 
 

Magyarország 
Pfizer Kft 
Tel: +36 1 488 3700 

28 



Česká republika 
Pfizer, spol. s r.o. 
Tel: +420 283 004 111 
 

Malta 
Vivian Corporation Ltd. 
Tel: +35621 344610 
 

Danmark 
Pfizer ApS 
Tlf: +45 44 201 100 
 

Norge 
Pfizer AS 
Tlf: +47 67 526 100 
 

Deutschland 
BioNTech Manufacturing GmbH 
Tel: +49 6131 90840 
 

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01  
 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal 
Tel: +372 666 7500 
 

Österreich 
Pfizer Corporation Austria Ges.m.b.H 
Tel: +43 (0)1 521 15-0  
 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 
 

Polska 
Pfizer Polska Sp. z o.o. 
Tel.: +48 22 335 61 00  
 

España 
Pfizer, S.L. 
Télf:+34914909900 
 

Portugal 
Pfizer Biofarmacêutica, Sociedade Unipessoal 
Lda  
Tel: +351 21 423 5500  
 

France 
Pfizer 
Tél +33 1 58 07 34 40 
 

România 
Pfizer Romania S.R.L 
Tel: +40 (0) 21 207 28 00  
 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: +385 1 3908 777 
 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: +386 (0) 1 52 11 400  
 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 
 

Slovenská republika 
Pfizer Luxembourg SARL, 
organizačná zložka 
Tel: +421 2 3355 5500  
 

Ísland 
Icepharma hf 
Simi: +354 540 8000 
 

Suomi/Finland 
Pfizer Oy 
Puh/Tel: +358 (0)9 430 040  
 

Italia 
Pfizer S.r.l. 
Tel: +39 06 33 18 21 
 

Sverige 
Pfizer AB 
Tel: +46 (0)8 550 520 00 
 

Κύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch) 
Tηλ: +357 22 817690 

United Kingdom (Northern Ireland) 
Pfizer Limited 
Tel: +44 (0) 1304 616161 
 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: +371 670 35 775 
 

 

 

29 



This leaflet was last revised in {MM/YYYY} 
 
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. 
 
------------------------------------------------------------------------------------------------------------------------ 
 
The following information is intended for healthcare professionals only: 
 
Administer Comirnaty intramuscularly after dilution as a course of 2 doses (0.3 mL each) at least 
21 days 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. 
 

THAWING PRIOR TO DILUTION 

 
 

• The multidose vial is stored frozen and 
must be thawed prior to dilution. 
Frozen vials should be transferred to an 
environment of 2 °C to 8 °C to thaw; a 
195 vial pack may take 3 hours to thaw. 
Alternatively, frozen vials may also be 
thawed for 30 minutes at temperatures 
up to 30 °C for immediate use. 

• 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.  
 

No more than 
2 hours at 

room 
temperature 
(up to 30 °C) 

30 

http://www.comirnatyglobal.com/


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.  

 
 

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

1.8 mL of 0.9% sodium chloride 
injection 

Pull back plunger to 1.8 mL to 
remove air from vial 

31 



 
 

• Gently invert the diluted dispersion 
10 times. Do not shake. 

• The diluted vaccine should present as 
an off-white dispersion with no 
particulates visible. Discard the diluted 
vaccine if particulates or discolouration 
are present. 

 

 
 

• The diluted vials should be marked 
with the appropriate date and time. 

• Do not freeze or shake the diluted 
dispersion. If refrigerated, allow the 
diluted dispersion to come to room 
temperature prior to use. 
 

Gently x 10 

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

32 



PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY 

 
 

• After dilution, the vial contains 
2.25 mL from which 6 doses of 0.3 mL 
can be extracted.  

• Using aseptic technique, cleanse the 
vial stopper with a single-use antiseptic 
swab. 

• Withdraw 0.3 mL of Comirnaty.  
 

Low dead-volume syringes and/or 
needles should be used in order to 
extract 6 doses from a single vial. The 
low dead-volume syringe and needle 
combination should have a dead 
volume of no more than 35 microlitres. 

 
If standard syringes and needles are 
used, there may not be sufficient 
volume to extract a sixth dose from a 
single vial. 

• Each dose must contain 0.3 mL of 
vaccine.   

• If the amount of vaccine remaining in 
the vial cannot provide a full dose of 
0.3 mL, discard the vial and any excess 
volume.  

• Discard any unused vaccine within 
6 hours after dilution. 

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

0.3 mL diluted  
vaccine 

33 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '3. how comirnaty is given', 'Section_Content': 'comirnaty is given after dilution as an injection of 0.3 ml into a muscle of your upper arm. you will receive 2 injections, given at least 21 days apart. after the first dose of comirnaty, you should receive a second dose of the same vaccine after 21 days to complete the vaccination course. if you have any further questions on the use of comirnaty, ask your doctor, pharmacist or nurse.', 'Entity_Recognition': [{'Text': 'comirnaty', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 6, 'BeginOffset': 40, 'EndOffset': 49, 'Score': 0.43031203746795654, 'Text': 'injection', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Text': '0.3', 'Type': 'NUMBER', 'BeginOffset': 53, 'EndOffset': 56}, {'Id': 0, 'BeginOffset': 67, 'EndOffset': 73, 'Score': 0.6958130598068237, 'Text': 'muscle', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 2, 'BeginOffset': 88, 'EndOffset': 91, 'Score': 0.9613873958587646, 'Text': 'arm', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': '2 injections', 'Type': 'TREATMENT', 'BeginOffset': 110, 'EndOffset': 122}, {'Text': '21', 'Type': 'NUMBER', 'BeginOffset': 139, 'EndOffset': 141}, {'Text': 'the same vaccine', 'Type': 'TREATMENT', 'BeginOffset': 225, 'EndOffset': 241}, {'Id': 10, 'BeginOffset': 242, 'EndOffset': 255, 'Score': 0.8897777795791626, 'Text': 'after 21 days', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_TREATMENT_NAME', 'Traits': [], 'Attributes': [{'Type': 'TREATMENT_NAME', 'Score': 0.6497992873191833, 'RelationshipScore': 0.627871036529541, 'RelationshipType': 'OVERLAP', 'Id': 9, 'BeginOffset': 272, 'EndOffset': 283, 'Text': 'vaccination', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': '21', 'Type': 'NUMBER', 'BeginOffset': 248, 'EndOffset': 250}, {'Text': 'the vaccination course', 'Type': 'TREATMENT', 'BeginOffset': 268, 'EndOffset': 290}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all vaccines, comirnaty can cause side effects, although not everybody gets them. very common side effects: may affect more than 1 in 10 people injection site: pain, swelling tiredness headache muscle pain joint pain chills, fever common side effects: may affect up to 1 in 10 people injection site redness nausea 26 uncommon side effects: may affect up to 1 in 100 people enlarged lymph nodes feeling unwell pain in limb insomnia injection site itching rare side effects: may affect up to 1 in 1,000 people temporary one sided facial drooping not known (cannot be estimated from the available data) severe allergic reaction 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.', 'Entity_Recognition': [{'Text': 'comirnaty', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all vaccines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 17}, {'Id': 5, 'BeginOffset': 39, 'EndOffset': 51, 'Score': 0.966289758682251, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6903327107429504}]}, {'Id': 6, 'BeginOffset': 99, 'EndOffset': 111, 'Score': 0.8990243077278137, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8150768280029297}]}, {'Id': 7, 'BeginOffset': 117, 'EndOffset': 123, 'Score': 0.29682573676109314, 'Text': 'affect', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 134, 'EndOffset': 135}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 139, 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{'Title': '5. how to store comirnaty', 'Section_Content': '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 to -60 . store in the original package in order to protect from light. 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 5 days at 2 to 8 , or up to 2 hours at temperatures up to 30 , prior to use. after dilution, store the vaccine at 2 to 30 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.', 'Entity_Recognition': [{'Text': 'comirnaty', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 181, 'EndOffset': 194}, {'Text': '-90', 'Type': 'NUMBER', 'BeginOffset': 342, 'EndOffset': 345}, {'Text': '-60', 'Type': 'NUMBER', 'BeginOffset': 349, 'EndOffset': 352}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 432, 'EndOffset': 443}, {'Id': 7, 'BeginOffset': 471, 'EndOffset': 482, 'Score': 0.999997615814209, 'Text': 'immediately', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_TREATMENT_NAME', 'Traits': [], 'Attributes': [{'Type': 'TREATMENT_NAME', 'Score': 0.4428710639476776, 'RelationshipScore': 0.6168684959411621, 'RelationshipType': 'OVERLAP', 'Id': 0, 'BeginOffset': 436, 'EndOffset': 443, 'Text': 'vaccine', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': 'the undiluted vaccine', 'Type': 'TREATMENT', 'BeginOffset': 565, 'EndOffset': 586}, {'Text': '5', 'Type': 'NUMBER', 'BeginOffset': 611, 'EndOffset': 612}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 621, 'EndOffset': 622}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 626, 'EndOffset': 627}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 639, 'EndOffset': 640}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 669, 'EndOffset': 671}, {'Text': 'dilution', 'Type': 'TREATMENT', 'BeginOffset': 694, 'EndOffset': 702}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 710, 'EndOffset': 721}, {'Id': 10, 'BeginOffset': 725, 'EndOffset': 726, 'Score': 0.6032617688179016, 'Text': '2', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_TREATMENT_NAME', 'Traits': [], 'Attributes': [{'Type': 'TREATMENT_NAME', 'Score': 0.5172812342643738, 'RelationshipScore': 0.9220974445343018, 'RelationshipType': 'OVERLAP', 'Id': 2, 'BeginOffset': 714, 'EndOffset': 721, 'Text': 'vaccine', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 730, 'EndOffset': 732}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 748, 'EndOffset': 749}, {'Text': 'any unused vaccine', 'Type': 'TREATMENT', 'BeginOffset': 765, 'EndOffset': 783}, {'Text': 'the vials', 'Type': 'TREATMENT', 'BeginOffset': 828, 'EndOffset': 837}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 904, 'EndOffset': 915}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 948, 'EndOffset': 960}, {'Text': 'discolouration', 'Type': 'PROBLEM', 'BeginOffset': 1007, 'EndOffset': 1021}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what comirnaty contains the active substance is covid-19 mrna vaccine. after dilution, the vial contains 6 doses of 0.3 ml with 30 micrograms mrna each. the other ingredients are: − ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (alc-0315) − 2-[(polyethylene glycol)-2000]-n,n-ditetradecylacetamide (alc-0159) − 1,2-distearoyl-sn-glycero-3-phosphocholine (dspc) − cholesterol − potassium chloride − potassium dihydrogen phosphate − sodium chloride − disodium phosphate dihydrate − sucrose − water for injections what comirnaty looks like and contents of the pack the vaccine is a white to off-white dispersion (ph: 6.9 - 7.9) provided in a multidose vial of 6 doses in a 2 ml clear vial (type i glass), with a rubber stopper and a flip-off plastic cap with aluminium seal. pack size: 195 vials', 'Entity_Recognition': [{'Text': 'comirnaty', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, 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