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1  
  
 
   
 
   
 
   
 
   
 
   
ANNEX I  
 
SUMMARY OF PRODUCT CHARACTERISTICS  
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2 This medicinal product is subject to additional m onitoring. 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 5 doses of 0.3 mL after dilution.  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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3  
Elderly population 
1RGRVDJHDGMXVWPHQWLVUHTXLUHGLQHOGHUO\LQGLYLGXDOV•  65 years of age. 
 Method of administration 
 Comirnaty should be administered intramuscularly. 
 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 
 
Traceab ility  
 
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), hype rventilation 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. 
 
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. 
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4  
Immunocompromised individuals 
 The efficacy, safety and immunogenicity of the va ccine 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 vacci ne 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 protecte d 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) 
 
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 temporar ily affect the ab ility to driv e or use machines. 
 
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5 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 tota l 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:  
 
VHU\FRPPRQ•  1/10),  
CRPPRQ•  1/100 to < 1/10),  
UQFRPPRQ•  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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6 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 
swellin
g 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 Comir naty, that were seropos itive for SARS-CoV-2 at 
baseline, was similar to that s een 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 a nd 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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7 5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties  
 Pharmacotherapeutic group: vaccines, ATC code:  J07BX  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-c ontrolled, 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 \HDUVRIDJHDQGROGHUZLWKDPLQLPXPRIRISDUWLFLSDQWVLQWKH•  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 st udy, participants were required 
to observe a minimum interval of 60 days before or after receipt of bl ood/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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8 COVID-19 (e.g. asthma, body mass index (BMI) •  30 kg/m2, chronic pulmonary disease, diabetes 
mellitus, hype rtension). 
 
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 s hortness 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 Cl opper and Pearson 
method ad
justed to the surveillance time. CI not ad justed for multiplicit y. 
 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% 
WRLQSDUWLFLSDQWV\HDUVRIDJHDQGROGHU  
 Additionally, subgroup analyses of the primary efficacy endpoint showed similar effi cacy point 
estimates across genders, racial and ethnic groups, and participants with medical comorbidities 
associated with high risk of severe COVID-19.   
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9 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 toxi city were investigated in ra ts in a combin ed fer tility 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-ditetradecyl acetamide (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  
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10 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 respons ibility 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 
x 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. 
x Once a vial is removed from the vial tray, it should be thawed for use.  
x 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 5 doses. 
 
Pack size: 195 vials  
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11 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  
 
 x 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. 
x Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake. 
x Prior to dilution, the thawed dispersion 
may contain white to off-white opaque amorphous particles.  
 
DILUTION  
 
 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, 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 
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12  
 x Equalise vial pressure before removing 
the needle from the vial stopper by 
withdrawing 1.8 mL air into the empty diluent syringe. 
 
 
 x Gently invert the diluted dispersion 10 times. Do not shake. 
x 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 
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13  
 x The diluted vials should be marked 
with the appropriate date and time. 
x 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  
 
 x After dilution, the vial contains 2.25 mL corresponding to 5 doses of 
0.3 mL. Withdraw the required 0.3 mL 
dose of diluted vaccine using a sterile needle.   
x 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.   
 
7. MARKETING AUTHORISATION HOLDER 
 
BioNTech Manufacturing GmbH 
An der Goldgrube 12 55131 Mainz Germany Phone: +49 6131 90840 
Fax: +49 6131 9084390 
[email protected]   
Record appropriate date and time. 
Use within 6 hours after dilution 
0.3 mL diluted  
vaccine 
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14 8. MARKETING AUTHORISATION NUMBER(S)  
 EU/1/20/1528  
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  Date of first authorisation: {DD month YYYY}   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 . 
    
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15  
 
     
 
    
 
    
 
 
    
ANNEX II 
 
A.  MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCES AND MANUFACTURERS RESPONSI BLE 
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 
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16 A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 
MANUFACTURERS RESPONSI BLE 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 exemp tion 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. 
 
x 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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17 C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  
x 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 fo r this product within 
6 months following authorisation.  
 
 D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 x Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the ag reed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 An updated RMP shoul d be s ubmitted: 
x At the request of the European Medicines Agency; 
x 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 th e 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 inform ation 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 inform ation about the synthetic process and 
control strategy for the excipient ALC-0159.  July 2021. Interim reports: January 2021, 
April 2021 
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18 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 
  
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19  
 
     
 
    
 
      
 
   
ANNEX III 
 
LABELLING AND PACKAGE LEAF LET 
  
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20  
 
     
 
    
 
    
 
     
A. LABELLING  
  
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21 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 5 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   
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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. 
 
 
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 
   
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23 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 
 
5 doses after dilution   
6. OTHER 
 
Discard date/time:     
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24  
  
 
   
 
   
 
   
 
   
 
   
B. PACKAGE LEAFLET 
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25 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. 
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 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 
x 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: x 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. 
x you 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.  
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 
 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 w ill be protected. 
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26  
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 wo rn 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 r eceive 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 
x injection site: pain, swelling  
x tiredness 
x headache 
x muscle pain  
x joint pain 
x chills, fever 
 Common side effects:  may affect up to 1 in 10 people 
x injection site redness  
x nausea 
 Uncommon side effects:  may affect up to 1 in 100 people 
x enlarged lymph nodes 
x feeling unwell  
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27 x pain in limb  
x insomnia  
x injection site itching  
 
Rare side effects: may affect up to 1 in 1,000 people  
x temporary one sided facial drooping 
 
Not known (cannot be estimated from the available data)  
x 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 a nd 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 m easures will help protect the environment. 
 
 
6. Contents of the pack and other information  What Comirnaty contains  
x The active substance is COVID-19 mRNA Vaccine. After dilution, the vial contains 5 doses 
of 0.3 mL with 30 micrograms mRNA 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-ditetradecyl acetamide (ALC-0159) 
 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) 
 cholesterol 
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28  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 5 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 
[email protected]  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  
Ȼɴɥɝɚɪɢɹ  
ɉɮɚɣɡɟɪɅɸɤɫɟɦɛɭɪɝɋȺɊɅɄɥɨɧ  
Ȼɴɥɝɚɪɢɹ  
7Hɥ   
 Magyarország 
Pfizer Kft 
Tel: +36 1 488 3700 
ýHVNiUHSXEOLND  
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  
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29 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   
 
ǼȜȜȐįĮ  
3IL]HUǼȜȜȐȢ$(  
ȉȘȜ  
 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, SRGUXåQLFD]DVYHWRYDQMHVSRGURþMD  
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, 
RUJDQL]DþQi]ORåND  
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  
 
ȀȪʌȡȠȢ  
3IL]HUǼȜȜȐȢǹǼ&\SUXV%UDQFK  
7ȘȜ +357 22 817690 United Kingdom 
Pfizer Limited 
Te
l: +44 (0) 1304 616161 
 
Latvija 3IL]HU/X[HPERXUJ6$5/ILOLƗOH/DWYLMƗ  
Tel.: +371 670 35 775   
 This leaflet was last revised in  
 This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agen cy 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. 
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30   
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 leafl et 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. 
 
Traceab ility  
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 
x Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the 
sterility of the prepared dispersion. 
x 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.  
x Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake. 
x Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous 
particles.  
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, using a 21 gauge or narrower needle and aseptic techniques.  
x Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe. 
x Gently invert the diluted dispersion 10 times. Do not shake. 
x The diluted vaccine should present as an off-white dispersion with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present. 
x The diluted vials should be marked with the appropriate date and time. 
x Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use. 
x After dilution, the vial contains 2.25 mL corresponding to 5 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle.  
x 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.    
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31  
 
 
 
   
 
   
 
   
 
 
Annex IV 
Conclusions on the granting of the conditional marketing authorisation presented by the 
European Medicines Agency 
 
 
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32 Conclusions presented by the European Medicines Agency on: 
x Conditional marketing authorisation  
The CHMP having considered the application is of the opinion that the risk-benefit balance is 
favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report. 
  
 
  
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Revised: 12/2020  1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE 
(VACCINATION PROVIDERS) 
 
EMERGENCY USE AUTHORIZATION (EUA) OF 
THE PFIZER-BIONTECH COVID-19 V ACCINE TO PREVENT CORONAVIRUS 
DISEASE 2019 (COVID-19) 
 
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use 
Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine , for active immunization to prevent 
COVID-19 in individuals 16 years of age and older.  SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS  
 
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must 
report all vaccine administration errors, all serious adverse events, cases of 
Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of 
Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR 
PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER 
EMERGENCY USE AUTHORIZATION” for  reporting requirements. 
 
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection 
administered as a series of two doses (0.3 mL each) 3 weeks apart.    
 See this Fact Sheet for instructions for preparation and administration. This Fact 
Sheet may have been updated. For the most recent Fact Sheet, please see 
www.cvdvaccine.com . 
 For information on clinical trials that are testing the use of the Pfizer-BioNTech 
COVID-19 Vaccine for active immunization against  COVID-19, please see 
www.clinicaltrials.gov .  
 
DESCRI PTION OF COVID-19  
 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have 
reported a wide range of symptoms, ranging from mild symptoms to severe illness. 
Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; 
headache; new loss of taste or smell; sore throat; congestion or runny nose; 
nausea or vomiting; diarrhea. 
 
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Revised: 12/2020  2 DOSAGE AND ADMINISTRATION 
 
Storage and Handling 
 During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 
 
Do not refreeze thawed vials.  
Frozen Vials Prior to Use 
 
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low temperature 
freezer between -80ºC to -60ºC (-112ºF to -76ºF). Vials must be kept frozen 
between -80ºC to -60ºC (-112ºF to -76ºF) and protected from light until ready to 
use.  
 
If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage 
when consistently re-filled to the top of the container with dry ice. Refer to the 
re-icing guidelines packed in the original thermal container for instructions 
regarding the use of the thermal container for temporary storage. The thermal 
container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF). 
Storage within this temperature range is not considered an excursion from the recommended storage condition.   
 Thawed Vials Before Dilution 
 Thawed Under Refrigeration 
Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] 
for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or 
3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials 
will thaw in less time.  
 
Thawed at Room Temperature For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach 
room temperature before dilution. 
 Undiluted vials may be stored at room temperature for no more than 2 hours.  
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Revised: 12/2020  3 Vials After Dilution 
 
x After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 
6 hours from the time of dilution. 
x During storage, minimize exposure to room light, and avoid exposure to 
direct sunlight and ultraviolet light. 
x Any vaccine remaining in vials must be discarded after 6 hours.  
x Do not refreeze.  
 
Dosing and Schedule 
 
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a 
series of two doses (0.3 mL each) 3 weeks apart.  
There are no data available on the interchangeability of the Pfize r-BioNTech 
COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination 
series. Individuals who have received one dose of Pfize r-BioNTech COVID-19 
Vaccine should receive a second dose of Pfize r-BioNTech COVID-19 Vaccine to 
complete the vaccination series.
  
 Dose Preparation 
 
Prior to Dilution  
x The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a 
volume of 0.45 mL, supplied as a frozen suspension that does not contain 
preservative. Each vial must be thawed and diluted prior to administration.  
x Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]  or at room 
temperature [up to 25ºC (77ºF)] (see Storage and Handling) . 
x Refer to thawing instructions in the panels below. 
 
Dilution 
Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not 
provided) to form the Pfizer-BioNTech COVID-19 Vaccine. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine 
and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride 
Injection or any other diluent. Do not use more than 1.8 mL of diluent.  
 After dilution, one vial contains up to 6 doses of 0.3 mL. Vial labels and cartons 
may state that after dilution, a vial contains 5 doses of 0.3 mL. The information on 
the number of doses per vial after dilution in this Fact Sheet supersedes the number of doses stated on vial labels and cartons.  
x Refer to dilution and dose preparation instructions in the panels below. 
 
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Revised: 12/2020  4 THAWING PRIOR TO DILUTION 
 x Thaw vial(s) of Pfizer-BioNTech 
COVID-19 Vaccine before use either 
by: 
o Allowing vial(s) to thaw in the 
refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for 
up to five days (120 hours).  
o Allowing vial(s) to sit at room 
temperature [up to 25ºC (77ºF)] for 
30 minutes. 
x Using either thawing method, vials 
must reach room temperature before dilution and must be diluted within 2 
hours.  
 x Before dilution invert vaccine vial 
gently 10 times.  
x Do not shake. 
x Inspect the liquid in the vial prior to 
dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. 
x Do not use if liquid is discolored or if other particles are observed.
 
DILUTION 
 x Obtain sterile 0.9% Sodium Chloride 
Injection, USP. Use only this as the 
diluent. 
x Using aseptic technique, withdraw 
1.8 mL of diluent into a transfer syringe 
(21-gauge or narrower needle). 
x Cleanse the vaccine vial stopper with a 
single-use antiseptic swab.  
x Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.
 
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Revised: 12/2020  5  x Equalize vial pressure before removing 
the needle from the vial by withdrawing 1.8 mL air into the empty diluent 
syringe .
 
 x Gently invert the vial containing the 
Pfizer-BioNTech COVID-19 Vaccine 
10 times to mix.  
x Do not shake. 
x Inspect the vaccine in the vial.  
x The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter.
 
 x Record the date and time of dilution on 
the Pfizer-BioNTech COVID-19 
Vaccine vial label.  
x Store between 2°C to 25°C (35°F to 
77°F).  
x Discard any unused vaccine 6 hours after dilution.
 
 
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Revised: 12/2020  6 PREPARATION OF INDIVIDUAL 0.3 mL DO SES OF PFIZER-BIONTECH 
COVID-19 VACCINE 
 x Using aseptic technique, cleanse the 
vial stopper with a single-use antiseptic 
swab, and withdraw 0.3 mL of the 
Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume 
syringe and/or needle. 
x Administer immediately.  
 Administration  
 Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white suspension. During the visual inspection,  
x verify the final dosing volume of 0.3 mL. 
x confirm there are no particulates and that no discoloration is observed.  
x do not administer if vaccine is discolored or contains particulate matter. 
 
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.  
 
After preparation, vials of Pfize r-BioNTech COVID-19 Vaccine contain up to six 
doses of 0.3mL. Low dead-volume syringes and/or needles can be used to extract 
up to six doses from a single vial. 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: 
 
x Each dose must contain 0.3 mL of vaccine.   
x If the amount of vaccine remaining in the vial cannot provide a full dose of 
0.3 mL, discard the vial and content.  
x Do not pool excess vaccine from multiple vials. 
 Contraindications  Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known 
history of a severe allergic reaction (e.g., anaphylaxis) to any component of the 
Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information) . 
 Warnings  
 
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.  
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Revised: 12/2020  7  
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of 
immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines  (https://www.cdc.gov/vaccines/covid-19/ ). 
 Immunocompromised persons, including individuals receiving immunosuppressant 
therapy, may have a diminished immune response to the Pfize r-BioNTech 
COVID-19 Vaccine. 
 Pfizer
-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. 
 Adverse React ions 
 Adverse reactions following the Pfizer -BioNTech COVID-19 Vaccine that have 
been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, 
malaise, and lymphadenopathy (see Full EUA Prescribing Information) .  
 
Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. 
 
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer -BioNTech COVID-19 Vaccine. 
 Use with Other Vaccines  There is no information on the co-administration of the Pfizer-BioNTech COVID-19 
Vaccine with other vaccines. 
 INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS  
As the vaccination provider, you must communicate to the recipient or their 
caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.cvdvaccine.com  to obtain the Fact Sheet) prior to the individual receiving 
Pfizer-BioNTech COVID-19 Vaccine, including: 
x FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 
Vaccine, which is not an FDA-approved vaccine. 
x The recipient or their caregiver has the option to accept or refuse 
Pfizer-BioNTech COVID-19 Vaccine. 
x The significant known and potential risks and benefits of Pfize r-BioNTech 
COVID-19 Vaccine, and the extent to which such risks and benefits are unknown. 
x Information about available alternative vaccines and the risks and benefits of 
those alternatives. 
 For information on clinical trials that are testing the use of the Pfizer-BioNTech 
COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov . 
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Revised: 12/2020  8  
Provide a vaccination card to the recipient or their caregiver with the date when the 
recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 
Vaccine.  Provide the v-safe  information sheet to vaccine recipients/caregivers and 
encourage vaccine recipients to participate in v-safe . V-safe  is a new voluntary 
smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe  asks questions that help CDC monitor the safety of COVID-19 
vaccines. V-safe  also provides second-dose reminders if needed and live 
telephone follow-up by CDC if participants r eport a significant health impact 
following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe . 
 
MANDATORY REQUIREMENTS FOR P FIZER-BIONTECH COVID-19 V ACCINE  
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION 
 In order to mitigate the risks of using this unapproved product under EUA and to 
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following 
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for 
active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must  be met): 
 
1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in indivi duals 
16 years of age and older.  
2. The vaccination provider must communicate to the individual receiving the 
Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information 
consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfize r-BioNTech COVID-19 Vaccine.  
 
3. The vaccination provider must include vaccination information in the 
state/local jurisdiction’s Immunization Information System (IIS) or other designated system.  
 
4. The vaccination provider is responsible for mandatory reporting of the 
following to the Vaccine Adverse Event Reporting System (VAERS): 
x vaccine administration errors whether or not associated with an 
adverse event,  
x serious adverse events* (irrespective of attribution to vaccination), 
x cases of Multisystem Inflammatory Syndrome (MIS) in adults and 
children, and 
x cases of COVID-19 that result in hospitalization or death.  
 Complete and submit reports to VAERS online at 
https://vaers.hhs.gov/reportevent.html . For further assistance with reporting 
to VAERS call  1-800-822-7967. The reports should include the words 
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Revised: 12/2020  9 “Pfizer -BioNTech COVID-19 Vaccine EUA” in the description section of the 
report.  
 
5. The vaccination provider is responsible for responding to FDA requests for 
information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech 
COVID-19 Vaccine to recipients. 
 * Serious adverse events are defined as: 
x Death; 
x A life-threatening adverse event; 
x Inpatient hospitalization or prolongation of existing hospitalization; 
x A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions; 
x A congenital anomaly/birth defect; 
x An important medical event that based on appropriate medical judgement 
may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above. 
 
OTHER ADVERSE EVENT REPORTING TO VAERS AND P FIZER INC.  
 
Vaccination providers may report to VAERS other adverse events that are not 
required to be reported using the contact information above.  
 
To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. 
 
Website Fax number Telephone number 
www.pfizersafetyr eporting.com 1-866-635-8337 1-800-438-1985 
 
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Revised: 12/2020  10 ADDITIONAL INFORMATION  
 
For general questions, visit the website or call the telephone number provided 
below.   To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, 
please scan the QR code provided below. 
 
Global website  Telephone number  
www.cvdvaccine.com 
 1-877-829-2619 
(1-877-VAX-CO19)  
 AVAILABLE ALTERNATIVES  
 There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials or availability under EUA of other COVID-19 vaccines.   
AUTHORITY FOR ISSUANCE OF THE EUA 
 The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during 
the COVID-19 pandemic. In response, FDA has issued an EUA for the unapproved 
product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against 
COVID-19 in individuals 16 years of age and older.  
FDA issued this EUA, based on Pfizer-BioNTech’s request and submitted data. 
 Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the 
Pfizer-BioNTech COVID-19 Vaccine may be effective for the prevention of 
COVID-19 in individuals as specified in the Full EUA Prescribing Information .  
 
This EUA for the Pfizer-BioNTech COVID-19 Vaccine w ill end when the Secretary 
of HHS determines that the circumstances justifying the EUA no longer exist or 
when there is a change in the approval status of the product such that an EUA is no longer needed.  
For additional information about Emergency Use Authorization visit FDA at: 
https://www.fda.gov/emer gency-preparedness-and-response/mcm-legal-regulatory-
and-policy-framework/emergency-use-authorization. 
 
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Revised: 12/2020  11 The Counterm easures Injury Compensation Program 
 
The Countermeasures Injury Compensation Program (CICP) is a federal program 
that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, 
devices, or other items used to prevent, diagnose, or treat the public during a public 
health emergency or a security threat. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp, email [email protected] , or ca ll: 1-855-266-2427. 
   
 
Manufactured by Pfizer Inc., New York, NY 10017   
 
Manufactured for 
BioNTech Manufacturing GmbH  
An der Goldgrube 12 55131 Mainz, Germany  
LAB-1450-3.0 
 Revised: December 2020  
END SHORT VERSION FACT SHEET 
Long Version (Full EUA Prescribing Information) Begins On Next Page  
  
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Revised: 12/2020  12  
FULL EMERGENCY USE 
AUTHORIZATION (EUA) PRESCRIBING 
INFORMATION 
 PFIZER-BIONTECH COVID-19 VACCINE  
 
 
 
 
 
 
 
FULL EMERGENCY USE AUTHORIZATION 
PRESCRIBING INFORMATION: CONTENTS* 
 
1 AUTHORIZED USE 
2 DOSAGE AND ADMINISTRATION 
2.1 Preparation for Administration 
2.2 Administration Information 
2.3  Vaccination Schedule for Individuals 16 Years of Age and Older 
3 DOSAGE FORMS AND STRENGTHS 
4 CONTRAINDICATIONS 
5 WARNINGS AND PRECAUTIONS 
5.1 Management of Acute Allergic Reactions  
5.2 Altered Immunocompetence  
5.3 Limitation of Effectiveness  
6 OVERALL SAFETY SUMMARY 
6.1 Clinical Trials Experience 
 
  8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING 
ADVERSE EVENTS AND VACCINE ADMINISTRATION 
ERRORS 
10 DRUG INTERACTIONS 
11 USE IN SPECIFIC POPULATIONS 
11.1 Pregnancy 
11.2 Lactation  
11.3 Pediatric Use 
11.4 Geriatric Use 
13 DESCRIPTION 
14 CLINICAL PHARMACOLOGY 
14.1 Mechanism of Action 
18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR 
EUA  
18.1 Efficacy in Participants 16 Years of Age and Older 
19 HOW SUPPLIED/STORAGE AND HANDLING 
20 PATIENT COUNSELING INFORMATION  
21 CONTACT INFORMATION 
 
* Sections or subsections omitted from the full emergency use authorization 
prescribing information are not listed. 
 
  
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Revised: 12/2020  13  
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION 
 
1 AUTHORIZED USE 
 Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. 
 2 DOSAGE AND ADMINISTRATION  
For intramuscular injection only. 
 2.1 Preparation for Administration 
 
Prior to Dilution 
 
x The Pfizer-BioNTech COVID-19 Vaccine Mu ltiple Dose Vial contains a volume of 0.45 mL, s upplied 
as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to 
administration. 
x Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] [see How Supplied/Storage and Handling (19)] . 
x Refer to thawing instructions in the panels below. 
 
Dilution 
 
x Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Do not use more than 1.8 mL of diluent. 
x ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the 
vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or 
any other diluent.  
x After dilution, one vial contains up to 6 doses of 0.3 mL.  Vial labels and cartons may state that after 
dilution, a vial contains 5 doses of 0.3 mL. The information on the number of doses per vial after dilution in this Fact Sheet supersedes the number of doses stated on vial labels and cartons.  
x Refer to dilution and dose preparation instructions in the panels below. 
 
 
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Revised: 12/2020  14 THAWING PRIOR TO DILUTION 
 x Thaw vial(s) of Pfizer-BioNTech COVID-19 
Vaccine before use either by: 
o Allowing vial(s) to thaw in the refrigerator [2ºC 
to 8ºC (35ºF to 46ºF)]. A carton of vials may take 
up to 3 hours to thaw, and thawed vials can be 
stored in the refrigerator for up to five days 
(120 hours).  
o Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. 
x Using either thawing method,  vials must reach room 
temperature before dilution and must be diluted within 2 hours. 
 
 x Before dilution invert vaccine vial gently 10 times.  
x Do not shake.  
x Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may 
contain white to off-white opaque amorphous 
particles. 
x Do not use if liquid is discolored or if other particles 
are observed. 
DILUTION  
 x Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. 
x Using aseptic technique, withdraw 1.8 mL of diluent 
into a transfer syringe (21-gauge or narrower 
needle). 
x Cleanse the vaccine vial stopper with a single-use antiseptic swab. 
x Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 
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Revised: 12/2020  15  x Equalize vial pressure before removing the needle 
from the vial by withdrawing 1.8 mL air into the 
empty diluent syringe. 
 x Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine 10 times to mix.  
x Do not shake. 
x Inspect the vaccine in the vial.  
x The vaccine w ill be an off-white suspension. Do not 
use if vaccine is discolored or contains particulate 
matter. 
 x Record the date and time of dilution on the 
Pfizer-BioNTech COVID-19 Vaccine vial label.  
x Store between 2°C to 25°C (35°F to 77°F).  
x Discard any unused vaccine 6 hours after dilution. 
 
 
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Revised: 12/2020  16 PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19 
VACCINE 
 x Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine 
preferentially using low dead-volume syringes and/or needles. 
x Administer immediately.  
 2.2 Administration Information 
 
Visually inspect each dose in the dosing syringe prior to administration. The vaccine w ill be an off-white 
suspension. During the visual inspection,  
x verify the final dosing volume of 0.3 mL. 
x confirm there are no particulates and that no discoloration is observed. 
x do not administer if vaccine is discolored or contains particulate matter. 
 
Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.  
 After preparation, vials of Pfizer-BioNTech COVID-19 V accine contain up to six doses of 0.3 mL. Low 
dead-volume syringes and/or needles can be used to extract up to six doses from a single vial. 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: 
 
x Each dose must contain 0.3 mL of vaccine.   
x 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.  
x Do not pool excess vaccine from mu ltiple vials. 
 2.3 Vaccination Schedule for Individuals 16 Years of Age and Older 
 The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL 
each) three weeks apart. 
 There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of 
Pfizer-BioNTech COVID-19 Vaccine s hould receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to 
complete the vaccination series. 
 3 DOSAGE FORMS AND STRENGTHS 
 
Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL. 
 
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Revised: 12/2020  17 4 CONTRAINDICATIONS 
 
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic 
reaction (e.g., anaphylaxis) to any component of the Pfize r-BioNTech COVID-19 Vaccine  [see Description 
(13)] . 
 5 WARNINGS AND PRECAUTIONS 
 
5.1 Management of Acute Allergic Reactions  Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in 
the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 
Vaccine.   Monitor Pfizer-BioNTech COVID-19 V accine recipients for the occurrence of immediate adverse reactions 
according to the Centers for Disease Control and Prevention guideline s (https://www.cdc.gov/vaccines/covid-
19/). 
 5.2 Altered Immunocompetence 
 Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. 
 
5.3 Limitation of Effectiveness 
 
The Pfizer-BioNTech COVID-19 Vaccine may not protect all v accine recipients. 
 
6 OVERALL SAFETY SUMMARY 
 It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem 
Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 
following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQ UIREMENTS AND INSTRUCTIONS FOR 
REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details 
on reporting to VAERS and Pfizer Inc.  In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site 
(84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), 
fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and 
lymphadenopathy (0.3%).   
 Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass 
vaccination outside of clinical trials.  6.1 Clinical Trials Experience 
 
Because clinical trials are c onducted under wide ly varying cond itions, adverse reaction rates observed in the 
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not 
reflect the rates observed in practice. 
  
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FDA-CBER-2021-5683-1078962
Revised: 12/2020  18 The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 years of age and older in 
two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. 
Study BNT162-01 (Study 1) was a Phase 1/2, two-part, dose-escalation trial that enrolled 60 participants, 
18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, mu lticenter, multinational, randomized, 
saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy 
(Phase 2/3) study that has enrolled approximately 44,000 participants, 12 years of age or older. Of these, 
approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 21,728 placebo) in Phase 2/3 
are 16 years of age or older (including 138 and 145 a dolescents 16 and 17 years of age in the vaccine and 
placebo groups, respectively). 
 
At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfize r-BioNTech COVID-19 V accine and 
18,785 pl acebo) participants 16 years of age or older have been followed for a median of 2 months after the 
second dose of Pfizer-BioN Tech COVID-19 Vaccine. 
 The safety evaluation in Study 2 is ongoing. The safety population includes participants enrolled by 
October 9, 2020, and includes safety data accrued through November 14, 2020. Participants 18 years and older 
in the reactogenicity subset are monitored for solicited local and systemic reactions and use of antipyretic 
medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited 
adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all 
unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. 
 Demographic characteristics in Study 2 were generally sim ilar with regard to age, gender, race, and ethnicity 
among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. 
Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.  
 
Local and Systemic Adverse Reactions Solicited in the Study 2 
 
Table 1 and Table 2 present the frequency and severity of solicited local and systemic reactions, respectively, 
within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of 
participants 18 to 55 years of age included in the EUA safety population who were monitored for reactogenicity 
with an electronic diary.  
 
Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, 
respectively, within 7 days of each dose of Pfize r-BioNTech COVID-19 V accine and placebo for participants 
56 years of age and older. 
 
Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 
36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for 
participants in the Pfizer-BioNTech COVID-19 Vaccine group. 
 
Solicited reactogenicity data in 16 and 17 year-old participants are limited. 
 
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FDA-CBER-2021-5683-1078963
Revised: 12/2020  19 Table 1:  Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by 
Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – 
Reactogenicity Subset of the Safety Population* 
 Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1  
Na=2291 
nb (%) Placebo 
Dose 1 
Na=2298 
nb (%) Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 2 
Na=2098 
nb (%) Placebo 
Dose 2 
Na=2103 
nb (%) 
Rednessc      
Any (>2 cm ) 104 (4.5) 26 (1.1) 123 (5.9) 14 (0.7) 
Mild 70 (3.1) 16 (0.7) 73 (3.5) 8 (0.4) 
Moderate 28 (1.2) 6 (0.3) 40 (1.9) 6 (0.3) 
Severe 6 (0.3) 4 (0.2) 10 (0.5) 0 (0.0) 
Swellin gc     
Any (>2 cm) 132 (5.8) 11 (0.5) 132 (6.3) 5 (0.2) 
Mild 88 (3.8) 3 (0.1) 80 (3.8) 3 (0.1) 
Moderate 39 (1.7) 5 (0.2) 45 (2.1) 2 (0.1) 
Severe 5 (0.2) 3 (0.1) 7 (0.3) 0 (0.0) 
Pain at the in jection sited     
Any 1904 (83.1) 322 (14.0) 1632 (77.8) 245 (11.7) 
Mild 1170 (51.1) 308 (13.4) 1039 (49.5) 225 (10.7) 
Moderate 710 (31.0) 12 (0.5) 568 (27.1) 20 (1.0) 
Severe 24 (1.0) 2 (0.1) 25 (1.2) 0 (0.0) 
Note: Reactions were collected in the electronic dia ry (e-dia ry) from Day 1 to Day 7 a fter vaccination. 
a .  N = Number of participants reporting a t lea st 1 yes or no response for the specified reaction a fter the specified dose.  
b. n = Number of participants with the specified reaction.  
c. Mild: >2.0 to ”5.0 cm; Moderate: >5.0 to ”10.0 cm; Severe: >10.0 cm. 
d. Mild: does not interfere with a ctivity; Moderate: interferes with a ctivity; Severe: prevents daily a ctivity.  
‡ Eight participants were between 16 and 17 years of age. 
* Ra ndomized participants in the safety a nalysis population who received a t lea st 1 dose of the study intervention. 
 
Table 2:  Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by 
Maximum Severity, Within 7 Days After Each Dose – Participants 18-55 Years of Age‡ – 
Safety Population* 
 Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1 
Na=2291 
nb (%) Placebo 
Dose 1 
Na=2298 
nb (%) Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 2 
Na=2098 
nb (%) Placebo 
Dose 2 
Na=2103 
nb (%) 
Fever     
•ႏ  85 (3.7) 20 (0.9) 331 (15.8) 10 (0.5) 
•ႏWRႏ  64 (2.8) 10 (0.4) 194 (9.2) 5 (0.2) 
>ႏWRႏ  15 (0.7) 5 (0.2) 110 (5.2) 3 (0.1) 
>ႏWRႏ  6 (0.3) 3 (0.1) 26 (1.2) 2 (0.1) 
!ႏ  0 (0.0) 2 (0.1) 1 (0.0) 0 (0.0) 
Fatiguec     
Any 1085 (47.4) 767 (33.4) 1247 (59.4) 479 (22.8) 
Mild 597 (26.1) 467 (20.3) 442 (21.1) 248 (11.8) 
Moderate 455 (19.9) 289 (12.6) 708 (33.7) 217 (10.3) 
Severe 33 (1.4) 11 (0.5) 97 (4.6) 14 (0.7) 
Headachec     
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FDA-CBER-2021-5683-1078964
Revised: 12/2020  20  Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1 
Na=2291 
nb (%) Placebo 
Dose 1 
Na=2298 
nb (%) Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 2 
Na=2098 
nb (%) Placebo 
Dose 2 
Na=2103 
nb (%) 
Any 959 (41.9) 775 (33.7) 1085 (51.7) 506 (24.1) 
Mild 628 (27.4) 505 (22.0) 538 (25.6) 321 (15.3) 
Moderate 308 (13.4) 251 (10.9) 480 (22.9) 170 (8.1) 
Severe 23 (1.0) 19 (0.8) 67 (3.2) 15 (0.7) 
Chillsc     
Any 321 (14.0) 146 (6.4) 737 (35.1) 79 (3.8) 
Mild 230 (10.0) 111 (4.8) 359 (17.1) 65 (3.1) 
Moderate 82 (3.6) 33 (1.4) 333 (15.9) 14 (0.7) 
Severe 9 (0.4) 2 (0.1) 45 (2.1) 0 (0.0) 
Vomitingd     
Any 28 (1.2) 28 (1.2) 40 (1.9) 25 (1.2) 
Mild 24 (1.0) 22 (1.0) 28 (1.3) 16 (0.8) 
Moderate 4 (0.2) 5 (0.2) 8 (0.4) 9 (0.4) 
Severe 0 (0.0) 1 (0.0) 4 (0.2) 0 (0.0) 
Diarrheae     
Any 255 (11.1) 270 (11.7) 219 (10.4) 177 (8.4) 
Mild 206 (9.0) 217 (9.4) 179 (8.5) 144 (6.8) 
Moderate 46 (2.0) 52 (2.3) 36 (1.7) 32 (1.5) 
Severe 3 (0.1) 1 (0.0) 4 (0.2) 1 (0.0) 
New or worsened 
muscle painc     
Any 487 (21.3) 249 (10.8) 783 (37.3) 173 (8.2) 
Mild 256 (11.2) 175 (7.6) 326 (15.5) 111 (5.3) 
Moderate 218 (9.5) 72 (3.1) 410 (19.5) 59 (2.8) 
Severe 13 (0.6) 2 (0.1) 47 (2.2) 3 (0.1) 
New or worsened 
joint painc     
Any 251 (11.0) 138 (6.0) 459 (21.9) 109 (5.2) 
Mild 147 (6.4) 95 (4.1) 205 (9.8) 54 (2.6) 
Moderate 99 (4.3) 43 (1.9) 234 (11.2) 51 (2.4) 
Severe 5 (0.2) 0 (0.0) 20 (1.0) 4 (0.2) 
Use of antipyretic or 
pain medicationf 638 (27.8) 332 (14.4) 945 (45.0) 266 (12.6) 
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 aft er 
each dose.  
a . N = Number of participants reporting a t lea st 1 yes or no response for the specified event a fter the specified dose. 
b. n = Number of participants with the specified reaction. c. Mild: does not interfere with a ctivity; Moderate: some interference with a ctivity; Severe: prevents daily a ctivity.  d. Mild: 1 to 2 times in 24 hours; Moder ate: >2 times in 24 hours; Severe: requires intravenous hydr ation. 
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours .  
f. Severity wa s not collected for use of antipyretic or pa in medication. 
‡ Eight participants were between 16 and 17 years of age.   
* Ra ndomized participants in the safety a nalysis population who received a t lea st 1 dose of the study intervention. 
 
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FDA-CBER-2021-5683-1078965
Revised: 12/2020  21 Table 3:  Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by 
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and 
Older – Safety Population* 
 Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1  
Na=1802 
nb (%) Placebo 
Dose 1 
Na=1792 
nb (%) Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 2 
Na=1660 
nb (%) Placebo 
Dose 2 
Na=1646 
nb (%) 
Rednessc      
Any (>2 cm ) 85 (4.7) 19 (1.1) 120 (7.2) 12 (0.7) 
Mild 55 (3.1) 12 (0.7) 59 (3.6) 8 (0.5) 
Moderate 27 (1.5) 5 (0.3) 53 (3.2) 3 (0.2) 
Severe 3 (0.2) 2 (0.1) 8 (0.5) 1 (0.1) 
Swellin gc     
Any (>2 cm) 118 (6.5) 21 (1.2) 124 (7.5) 11 (0.7) 
Mild 71 (3.9) 10 (0.6) 68 (4.1) 5 (0.3) 
Moderate 45 (2.5) 11 (0.6) 53 (3.2) 5 (0.3) 
Severe 2 (0.1) 0 (0.0) 3 (0.2) 1 (0.1) 
Pain at the injection site
d     
Any (>2 cm ) 1282 (71.1) 166 (9.3) 1098 (66.1) 127 (7.7) 
Mild 1008 (55.9) 160 (8.9) 792 (47.7) 125 (7.6) 
Moderate 270 (15.0) 6 (0.3) 298 (18.0) 2 (0.1) 
Severe 4 (0.2) 0 (0.0) 8 (0.5) 0 (0.0) 
Note: Reactions were collected in the electronic dia ry (e-dia ry) from Day 1 to Day 7 a fter vaccination.  
a . N = Number of participants reporting a t lea st 1 yes or no response for the specified reaction a fter the specified dose.  
b. n = Number of participants with the specified reaction. 
c. Mild: >2.0 to ”5.0 cm; Moderate: >5.0 to ”10.0 cm; Severe: >10.0 cm.  
d.  Mild: does not interfere with a ctivity; Moderate: interferes with a ctivity; Severe: prevents daily a ctivity. 
* Ra ndomized participants in the safety a nalysis population who received a t lea st 1 dose of the study intervention. 
 
Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by 
Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and 
Older – Reactogenicity Subset of the Safety Population* 
 Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1  
Na=1802 
nb (%) Placebo 
Dose 1 
Na=1792 
nb (%) Pfizer-BioNTech 
COVID-19 
Vaccine 
Dose 2 
Na=1660 
nb (%) Placebo 
Dose 2 
Na=1646 
nb (%) 
Fever     
•ႏ  26 (1.4) 7 (0.4) 181 (10.9) 4 (0.2) 
•ႏWRႏ  23 (1.3) 2 (0.1) 131 (7.9) 2 (0.1) 
!ႏWRႏ  1 (0.1) 3 (0.2) 45 (2.7) 1 (0.1) 
!ႏWRႏ  1 (0.1) 2 (0.1) 5 (0.3) 1 (0.1) 
!ႏ  1 (0.1) 0 (0.0) 0 (0.0) 0 (0.0) 
Fatiguec     
Any 615 (34.1) 405 (22.6) 839 (50.5) 277 (16.8) 
Mild 373 (20.7) 252 (14.1) 351 (21.1) 161 (9.8) 
Moderate 240 (13.3) 150 (8.4) 442 (26.6) 114 (6.9) 
Severe 2 (0.1) 3 (0.2) 46 (2.8) 2 (0.1) 
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FDA-CBER-2021-5683-1078966
Revised: 12/2020  22  Pfizer-BioNTech 
COVID-19 Vaccine 
Dose 1  
Na=1802 
nb (%) Placebo 
Dose 1 
Na=1792 
nb (%) Pfizer-BioNTech 
COVID-19 
Vaccine 
Dose 2 
Na=1660 
nb (%) Placebo 
Dose 2 
Na=1646 
nb (%) 
Headachec     
Any 454 (25.2) 325 (18.1) 647 (39.0) 229 (13.9) 
Mild 348 (19.3) 242 (13.5) 422 (25.4) 165 (10.0) 
Moderate 104 (5.8) 80 (4.5) 216 (13.0) 60 (3.6) 
Severe 2 (0.1) 3 (0.2) 9 (0.5) 4 (0.2) 
Chillsc     
Any 113 (6.3) 57 (3.2) 377 (22.7) 46 (2.8) 
Mild 87 (4.8) 40 (2.2) 199 (12.0) 35 (2.1) 
Moderate 26 (1.4) 16 (0.9) 161 (9.7) 11 (0.7) 
Severe 0 (0.0) 1 (0.1) 17 (1.0) 0 (0.0) 
Vomitingd     
Any 9 (0.5) 9 (0.5) 11 (0.7) 5 (0.3) 
Mild 8 (0.4) 9 (0.5) 9 (0.5) 5 (0.3) 
Moderate 1 (0.1) 0 (0.0) 1 (0.1) 0 (0.0) 
Severe 0 (0.0) 0 (0.0) 1 (0.1) 0 (0.0) 
Diarrheae     
Any 147 (8.2) 118 (6.6) 137 (8.3) 99 (6.0) 
Mild 118 (6.5) 100 (5.6) 114 (6.9) 73 (4.4) 
Moderate 26 (1.4) 17 (0.9) 21 (1.3) 22 (1.3) 
Severe 3 (0.2) 1 (0.1) 2 (0.1) 4 (0.2) 
New or worsened 
muscle painc     
Any 251 (13.9) 149 (8.3) 477 (28.7) 87 (5.3) 
Mild 168 (9.3) 100 (5.6) 202 (12.2) 57 (3.5) 
Moderate 82 (4.6) 46 (2.6) 259 (15.6) 29 (1.8) 
Severe 1 (0.1) 3 (0.2) 16 (1.0) 1 (0.1) 
New or worsened joint 
painc     
Any 155 (8.6) 109 (6.1) 313 (18.9) 61 (3.7) 
Mild 101 (5.6) 68 (3.8) 161 (9.7) 35 (2.1) 
Moderate 52 (2.9) 40 (2.2) 145 (8.7) 25 (1.5) 
Severe 2 (0.1) 1 (0.1) 7 (0.4) 1 (0.1) 
Use of antipyretic or 
pain medication 358 (19.9) 213 (11.9) 625 (37.7) 161 (9.8) 
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 aft er 
each dose. 
a . N = Number of participants reporting a t lea st 1 yes or no response for the specified event a fter the specified dose. 
b. n = Number of participants with the specified reaction.  
c. Mild: does not interfere with a ctivity; Moderate: some interference with a ctivity; Severe: prevents daily a ctivity.  d. Mild: 1 to 2 times in 24 hours; Moder ate: >2 times in 24 hours; Severe: requires intravenous hydr ation. 
e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours .  
* Ra ndomized participants in the safety a nalysis population who received a t lea st 1 dose of the study intervention. 
 
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FDA-CBER-2021-5683-1078967
Revised: 12/2020  23 Unsolicited Adverse Events 
 
Serious Adverse Events 
 
In Study 2, among participants 16 to 55 years of age w ho had received at least 1 dose of vaccin e or placebo 
(Pfizer-BioNTech COVID-19 Vaccine = 10, 841; placebo = 10,851), serious adverse events from Dose 1 
through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 
Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years of age and 
older (Pfizer-BioNTech COVID-19 V accine = 7960, placebo = 7934), serious adverse events were reported by 
0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of pl acebo recipients who received at 
least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study 
participants had at least 30 days of follow-up after Dose 2. Appendicitis was reported as a serious adverse event 
for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo 
participants. Currently available information is insufficient to determine a causal relationship with the vaccine. 
There were no other notable patterns or numerical imbalances between treatment groups for specific categories 
of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest 
a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 
 
Non-Serious Adverse Events 
 
Overall in Study 2 in which 10,841 particip ants 16 to 55 years of  age received Pfize r-BioNTech COVID-19 
Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 
30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received 
Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the pl acebo gr oup, for participants who 
received at least 1 dose. Overall in a similar analysis  in which 7960 participants 56 years of age and older 
received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 
23.8% of participants who received Pfize r-BioNTech COVID-19 V accine and 11.7% of participants in the 
placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had 
at least 30 days of follow-up after Dose 2. The higher frequency of reported unsolicited non-serious adverse 
events among Pfizer BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily 
attributed to local and systemic adverse events reported during the first 7 days following vaccination that are 
consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in 
Tables 3 and 4. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with 
notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is 
plausibly related to vaccination. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis) 
was reported by four participants in the Pfizer-BioNTech COVID-19 V accine group. Onset of facial paralysis 
was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of 
Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a 
causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between 
treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-
inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 
Vaccine. 
 
8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND 
VACCINE ADMINISTRATION ERRORS  
 
See Overall Safety Summary (Section 6) for additional information. 
 
The vaccination provider enrolled in the federal COVID-19 Vaccination Prog ram is responsible for 
MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the V accine 
Adverse Event Reporting System (VAERS): 
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Revised: 12/2020  24 x Vaccine administration errors whether or not associated with an adverse event 
x Serious adverse events* (irrespective of attribution to vaccination) 
x Cases of Multisystem Inflammatory S yndrome (MIS) in children and adults 
x Cases of COVID-19 that result in hospitalization or death 
 
*Serious adverse events are defined as: 
x Death 
x A life-threatening adverse event 
x Inpatient hospitalization or prolongation of existing hospitalization 
x A persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions 
x A congenital anomaly/birth defect 
x An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above 
 
Instructions for Reporting to VAERS 
 The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a 
VAERS form to FDA using one of the following methods: 
x Complete and submit the report online: https://vaers.hhs.gov/reportevent.html , or  
x If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need add itional help submitting a report you may call the VAERS toll-free information line at 
1-800-822-7967 or send an email to [email protected]. 
 
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include: 
x Patient demographics (e.g., patient name, date of birth)  
x Pertinent medical history  
x Pertinent details regarding admission and course of illness  
x Concomitant medications  
x Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19 
Vaccine 
x Pertinent laboratory and virology information  
x Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.  
 The following steps are highlighted to provide the necessary information for safety tracking: 
1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within 
one month prior. 
2. In Box 18, description of the event: 
a. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line. 
b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for 
ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above. 
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Revised: 12/2020  25 3. Contact information: 
a. In Box 13, provide the name and contact information of the prescribing healthcare provider or 
institutional designee who is res ponsible for the report.  
b. In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event. 
c. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address). 
 
Other Reporting Instructions 
 Vaccination providers may report to VAERS other adverse events that are not required to be reported using the 
contact information above. 
 To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a 
copy of the VAERS form to Pfizer Inc. 
 
Website Fax number Telephone number 
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985 
 10 DRUG INTERACTIONS 
 There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 V accine with 
other vaccines. 
 
11 USE IN SPECIFIC POPULATIONS  11.1 Pregnancy 
 
Risk Summary  
 
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the 
estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 
4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.  
 
11.2 Lactation  
 
Risk Summary 
 
Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on 
milk production/excretion.  
 11.3 Pediatric Use 
 Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in adolescents 16 and 17 years of age is based on extrapolation of safety and effectiveness from adults 18 years of age and older. Emergency Use Authorization of Pfizer BioNTech COVID-19 Vaccine does not include use in individuals younger than 
16 years of age. 
 
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FDA-CBER-2021-5683-1078970
Revised: 12/2020  26 11.4 Geriatric Use 
 
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their 
data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical 
Trial Results and Supporting Data for EUA (18.1)] . Of the total number of Pfizer-BioNTech COVID-19 
Vaccine recipients in  Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) 
were 75 years of age and older.  
 
13 DESCRIPTION   The Pfizer-BioNTech COVID-19 Vaccine is s upplied as a frozen suspension in multiple dose vials; each vial 
must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.   
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg 
(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg 
dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) 
contributes an additional 2.16 mg sodium chloride per dose.  The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial st oppers are not made with 
natural rubber latex.   14 CLINICAL PHARMACOLOGY  
14.1 Mechanism of Action 
 The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an 
immune response to the S antigen, which protects against COVID-19. 
 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA  
 
18.1 Efficacy in Participants 16 Years of Age and Older 
 Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, 
dose-finding, vaccine candidate–selection, and efficacy study in participants 12 years of age and older. 
Randomization 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 particip DQWVLQWKH• -year stratum. The study excluded participants who 
were immunocompromised and those who had previous  clinical or microbiological diagnosis of COVID-19. 
Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepa titis C virus (HCV), or hepatitis B 
virus (HBV).   
In the Phase 2/3 portion approximately 44,000 participants 12 years of age and older were randomized equally 
and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine or placebo separated by 21 days. Participants are 
planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.  
 
&21),'(17,$/ 3DJH090177e1960238b8\A pproved\A pproved On: 14-Jan-2021 07:46 (GMT )
FDA-CBER-2021-5683-1078971
Revised: 12/2020  27 The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age 
and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine gr oup and 18,379 in the placebo gr oup) who did 
not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 5 presents 
the specific demographic characteristics in the studied population.  
 Table 5:  Demographics (population for the primary efficacy endpoint)
a 
 Pfizer-BioNTech  
COVID-19 Vaccine 
(N=18,242) 
n (%) Placebo 
(N=18,379) 
n (%) 
Sex   
Male  9318 (51.1) 9225 (50.2) 
Female  8924 (48.9)  9154 (49.8)  
Age (years)    
Mean (SD) 50.6 (15.70 ) 50.4 (15.81 ) 
Median 52.0  52.0  
Min, max (12, 89 ) (12, 91 ) 
Age group   
•WKURXJK\HDUV 46 (0.3) 42 (0.2) 
•WKURXJK\HDUV 66 (0.4) 68 (0.4) 
•WKURXJK\HDUV  14,216 (77.9) 14,299 (77.8) 
•WKURXJK years 3176 (17.4) 3226 (17.6) 
•\HDUV 804 (4.4) 812 (4.4) 
Race   
White 15,110 (82.8) 15,301 (83.3) 
Black or African American 1617 (8.9) 1617 (8.8) 
American Indian or Alaska Native 118 (0.6) 106 (0.6) 
Asian 815 (4.5) 810 (4.4) 
Native Hawaiian or other Pacific Islander 48 (0.3) 29 (0.2) 
Otherb 534 (2.9) 516 (2.8) 
Ethnicit y   
Hispanic or Latino 4886 (26.8) 4857 (26.4) 
Not His panic or Latino 13,253 (72.7) 13,412 (73.0) 
Not re ported 103 (0.6) 110 (0.6) 
Comorbiditiesc   
Yes 8432 (46.2) 8450 (46.0) 
No 9810 (53.8) 9929 (54.0) 
a. All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no othe r 
important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days 
after Dose 2.  
b. Includes multira cial a nd not reported. 
c. Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease 
x Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or 
moder ate to severe asthma 
x Significa nt cardia c disease (e.g., hea rt failure, coronary a rtery disease, congenital heart disease, ca rdiomyopathies, a nd 
pulmonary hypertension) 
x 2EHVLW\ERG\PDVVLQGH[•NJP2) 
x Diabetes (Type 1, Type 2 or gestational) 
x Liver disease 
x Human Immunodeficiency Virus (HIV) infection (not included in the e
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