Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)
Conditions: COVID-19
Sponsor: Pfizer

COMIRNATY Intramuscular Injection 
C4591019 NON-INTERVENTIONA L STUDY PROTOCOL
PFIZER CONFIDENTIAL 
Page 1 of 33 
 
 
Amended 2,  27  May  2021  
 
 
(Appendix) 
 
 
 
 
 
 
 
 
 
 
 
 
Special Investigation of COMIRNATY Intramuscular Injection 
 
(Investigation of Patients with Underlying Disease Considered to be at High Risk of Aggravation of 
COVID-19) 
Full Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pfizer Japan Inc. 
 
 
 
 
 
 
This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, 
by accepting or reviewing this document, you agree to hold this information in confidence and not copy or 
disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In the event 
of any actual or suspected breach of this obligation, Pfizer must be promptly notified. 

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COMIRNATY Intramuscular Injection 
C4591019 NON-INTERVENTIONA L STUDY PROTOCOL 
Amended 2, 27 May 2021 
PFIZER CONFIDENTIAL 
Page 3 of 33 
 
 
 
 
 
1. TABLE OF CONTENTS 
1. TABLE OF CONTENTS........................................................................................................................... 3 
2. LIST OF ABBREVIATIONS .................................................................................................................... 6 
 
3. RESPONSIBLE PARTIES ........................................................................................................................ 7 
4. AMENDMENTS AND UPDATES ........................................................................................................... 8 
5. MILESTONES........................................................................................................................................... 8 
 
6. RATIONALE AND BACKGROUND ...................................................................................................... 8 
7. RESEARCH QUESTION AND OBJECTIVES........................................................................................ 9 
7.1. Safety specifications ......................................................................................................................... 9 
8. RESEARCH METHODS .......................................................................................................................... 9 
 
8.1. Study design...................................................................................................................................... 9 
8.2. Setting ............................................................................................................................................. 10 
8.2.1. Registration criteria ............................................................................................................ 10 
 
8.2.2. Exclusion criteria................................................................................................................ 11 
8.2.3. Study sites .......................................................................................................................... 11 
8.2.4. Planned study period .......................................................................................................... 11 
8.2.5. Study procedures ................................................................................................................ 11 
 
8.2.6. Observation period ............................................................................................................. 11 
8.3. Variable........................................................................................................................................... 12 
8.3.1. Characteristics of vaccinated subjects ................................................................................ 14 
 
8.3.2. Pregnancy and lactation (women only) .............................................................................. 14 
8.3.3. Status of vaccination with this product .............................................................................. 14 
8.3.4. End-of-study/discontinuation record .................................................................................. 15 
8.3.5. Information on inoculation of other vaccines..................................................................... 15 
 
8.3.6. Information on COVID-19 pathogen (SARS-CoV-2) test ................................................. 15 
8.3.7. Information on COVID-19 ................................................................................................. 15 
8.3.8. Adverse events ................................................................................................................... 16 
 
8.3.9. Health observation diary .................................................................................................... 17 
8.4. Data sources.................................................................................................................................... 18 
8.5. Study size........................................................................................................................................ 19 
8.5.1. Planned sample size ........................................................................................................... 19 
 
8.5.2. Rationale for sample size ................................................................................................... 19 
8.6. Data management ........................................................................................................................... 19 
8.6.1. Case report forms (CRFs)/Electronic data record .............................................................. 19 
8.6.2. Record retention ................................................................................................................. 20 

COMIRNATY Intramuscular Injection 
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8.6.3. Data collection method....................................................................................................... 20 
8.6.4. Subject registration (EDC) ................................................................................................. 20 
8.6.5. Points to consider for completion, revision, and submission of case report form 
(EDC) .............................................................................................................................. 20 
 
8.7. Data analysis ................................................................................................................................... 21 
8.7.1. Definition of analysis set .................................................................................................... 21 
8.7.2. Safety analyses ................................................................................................................... 21 
 
8.7.3. Analysis of specific adverse events (health observation diary).......................................... 21 
8.7.4. Analyses of information on COVID-19 ............................................................................. 21 
8.8. Quality control ................................................................................................................................ 21 
8.9. Limitations of the research methods ............................................................................................... 21 
 
8.10. OTHER NECESSARY MATTERS ............................................................................................. 22 
9. PROTECTION OF HUMAN SUBJECTS............................................................................................... 22 
9.1. Information of vaccinated subjects ................................................................................................. 22 
9.2. Consent of vaccinated subjects ....................................................................................................... 22 
 
9.3. Subject withdrawal ......................................................................................................................... 23 
9.4. Institutional review board (IRB)/Independent ethics committee (IEC) .......................................... 23 
9.5. Ethical conduct of the study............................................................................................................ 23 
 
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS ............. 23 
10.1. Record and report requirements.................................................................................................... 23 
10.2. Reporting period ........................................................................................................................... 24 
10.3. Evaluation of causal relationship .................................................................................................. 25 
 
10.4. Safety event definition .................................................................................................................. 25 
10.4.1. Adverse events ................................................................................................................. 25 
10.4.2. Serious adverse events ..................................................................................................... 26 
 
10.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours ................................. 27 
10.5. Single Reference Safety Document .............................................................................................. 30 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS ............................ 30 
12. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION................................................ 31 
13. NAME, AND ADDRESS OF CONTRACTOR AS WELL AS SCOPE OF WORK 
CONTRACTED .................................................................................................................................... 31 
14. ADDITIONAL MEASURES THAT MAY BE TAKEN BASED ON THE STUDY RESULTS 
AND CRITERIA FOR DETERMINATION OF THE INITIATION ................................................... 31 
15. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR 
EVALUATION OF STUDY IMPLEMENTATION STATUS AND RESULTS AND 
REPORTING TO THE PMDA ............................................................................................................. 31 

COMIRNATY Intramuscular Injection 
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PFIZER CONFIDENTIAL 
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16. OTHER NECESSARY MATTERS ...................................................................................................... 31 
17. CONTACT INFORMATION ................................................................................................................ 32 
 
17.1. Contact information for inquiries about the study ........................................................................ 32 
17.2. Contact information for inquiries about the EDC system ............................................................. 32 
18. REFERENCES ...................................................................................................................................... 32 
 
19. LIST OF TABLES ................................................................................................................................. 32 
20. LIST OF FIGURES ............................................................................................................................... 33 
APPENDIX 1. LIST OF STAND ALONE DOCUMENTS ........................................................................ 33 
APPENDIX 2. ADDITIONAL INFORMATION ....................................................................................... 33 

COMIRNATY Intramuscular Injection 
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PFIZER CONFIDENTIAL 
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2. LIST OF ABBREVIATIONS 
 
Abbreviation Definition 
ECMO 
Extracorporeal membrane oxygenation 
ICU 
Intensive care unit 
IEC 
Independent ethics committee 
IRB 
Institutional review board 
N/A 
Not applicable 
SAP 
Statistical analysis plan 
SRSD 
Single reference safety document 
VAED 
Vaccine-associated enhanced disease 
VAERD 
Vaccine-associated enhanced respiratory disease 
WHO 
World Healthcare Organization 

COMIRNATY Intramuscular Injection 
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PFIZER CONFIDENTIAL 
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3. RESPONSIBLE PARTIES 
The Japan Good Post-marketing Study Practice officer 

COMIRNATY Intramuscular Injection 
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Amended 2, 27 May 2021 
PFIZER CONFIDENTIAL 
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4. AMENDMENTS AND UPDATES 
 
Protocol 
version 
identifier 
Date 
Protocol 
section(s) 
changed 
Summary of 
amendment(s) 
Reason 
Amended 1 
26 February 2021 
8.3.1. 
Characteristics of 
vaccinated 
subjects 
Change the History of 
other vaccinations to 
“within 2 weeks before 
the date of the first 
vaccination with this 
product” 
Because the final 
version of pre- 
vaccination 
screenin g 
Questionnaire has 
changed 
Final 
13 February 2021 
N/A 
N/A 
N/A 
 
 
5. MILESTONES 
 
Milestone 
Planned date 
Start of data collection 
April 2021 
End of data collection 
December 2021 
Interim report 
To be determined 
Final study report 
To be determined 
 
 
6. RATIONALE AND BACKGROUND 
In December 2019, pneumonia of unknown cause became epidemic in Wuhan China. In January 2020, it 
was revealed that a novel coronavirus (2019-nCoV) was the cause. On 12 February 2020, the virus was 
officially named SARS-CoV-2 and the WHO officially named the disease caused by SARS-CoV-2 as 
COVID-19. 
SARS-CoV-2 and the resultant COVID-19 have spread globally with a steadily increasing number of 
individuals infected. 
 
BioNTech has developed RNA vaccine candidates using a platform that enables rapid development of 
vaccines against emerging viral diseases, including SARS-CoV-2. RNA vaccines encoding viral antigens 
have a significant advantage compared to conventional vaccines because they express proteins that induce 
a protective immune response in the vaccinated body and can be developed and manufactured rapidly. 
 
COMIRNATY  intramuscular  injection  (generic  name:  tozinameran)  (hereinafter  referred  to  as  this 
product) is an RNA vaccine containing mRNA encoding the spike protein of SARS-CoV-2, and its 
marketing approval was obtained in February 2021 with the indication of prevention of infection with 
SARS-CoV-2. 
 
This product is a highly novel vaccine and the safety information in Japanese subjects obtained by the time 
of marketing approval is limited. A wide range of people are expected to be vaccinated with this product 
after marketing approval is granted, and it is considered highly necessary to collect post-marketing safety 
information. 

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Considering  that  a  focused  investigation  in  healthcare  professionals  (hereinafter  referred  to  as 
Investigation of Health Status of Recipients Vaccinated First) is planned at an early stage after the start of 
vaccination with a new corona vaccine as Science Research of the Ministry of Health, Labour and Welfare 
(designated research) immediately after the marketing approval, a special investigation will be conducted 
in patients with underlying disease considered to be at high risk of aggravation of COVID-19 in Japan for 
whom no existing safety information is available, with the aim of avoid overlapping of subjects and based 
on the plan of the clinical study in Japan. 
 
 
 
This Study shall be conducted in strict compliance with the "MHLW Ordinance on the Standard for Post- 
Marketing Studies and Clinical Trials of Medical Products" (MHLW Ordinance No. 171, dated December 
20, 2004) , the "Enforcement of the MHLW Ordinance on the Standard for Post-marketing Studies and 
Clinical  Trials  of  Medical  Products"  (PFSB  Notification  No.  1220008,  dated  December  20,  2004), 
"MHLW Ordinance to Partially Amend the MHLW Ordinance on the Standard for Post-marketing Safety 
Control of Medical Products, Quasi-medical Products, Cosmetics, and Medical Devices and to Partially 
Amend the MHLW Ordinance on the Standard for Post-marketing Studies and Clinical Trials of Medical 
Products" (MHLW Ordinance No. 26, dated March 11, 2013), the "Enforcement of the MHLW Ordinance 
to Partially Amend the MHLW Ordinance on the Standard for Post-marketing Safety Control of Medical 
Products, Quasi-medical Products, Cosmetics, and Medical Devices, and to Partially Amend the MHLW 
Ordinance on the Standard for Post-marketing Studies and Clinical Trials of Medical Products" (PFSB 
Notification No. 0311-7, dated March 11, 2013)., "MHLW Ordinance to Partially Amend the MHLW 
Ordinance on the Standard for Post-marketing Studies and Clinical Trials of Medical Products" (MHLW 
Ordinance No. 116, dated October 26, 2017), and "Announcement of the MHLW Ordinance to Partially 
Amend the MHLW Ordinance on the Standard for Post-marketing Studies and Clinical Trials of Medical 
Products (Regarding the MHLW Ordinance on the Standard for Post-Marketing Studies and Clinical Trials 
of Medical Products)" (PSEHB Notification No. 1026-1, dated October 26, 2017). 
 
7. RESEARCH QUESTION AND OBJECTIVES 
This investigation intends to collect information on adverse events and COVID-19 observed after 
vaccination with this product and to assess safety in patients with underlying disease considered to be at 
high risk of aggravation of COVID-19 after marketing approval. 
 
7.1. Safety specifications 
[Important Identified Risks] 
 
            Shock, anaphylaxis 
 
[Important Potential Risks] 
 
            Vaccine-associated enhanced disease (VAED) and vaccine-associated enhanced respiratory disease 
(VAERD) 
 
[Important Missing Information] 
 
            Safety of administration to pregnant or lactating women 
 
8. RESEARCH METHODS 
8.1. Study design 

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This is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be 
at high risk of aggravation of COVID-19 who are vaccinated with this product, and the investigator will 

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PFIZER CONFIDENTIAL 
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enter the information required in this study in the case report forms (CRFs) based on the information 
obtained through preliminary examination sheet or medical interview, etc. and records such as medical 
records. A health observation diary will be distributed to the subjects participating in this study and they 
will be requested to record information on local reactions and systemic reactions (including pyrexia) after 
vaccination with this product. 
 
The investigator will collect the health observation diary after the end of the observation period of each 
CRF, and check the details of the records other than the symptoms at the vaccination site and general 
symptoms specified in the diary (including the COVID-19 information) as needed and enter them as 
adverse events. The investigator will not enter the symptoms at the vaccination site (local reactions) and 
general symptom (systemic reactions) specified in the health observation diary in the CRFs to avoid 
overlapping with adverse events evaluated by physicians. 
 
All assessments specified in this full protocol are performed as part of normal clinical practice or standard 
practice guidelines for the subject population and healthcare provider specialty in the countries where this 
non-interventional study is being conducted. 
 
8.2. Setting 
8.2.1. Registration criteria 
Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: Subject 
registration will be performed within 21 days at the latest after the first vaccination with this product 
(before the second vaccination). 
 
1. 
Subjects who are able to understand the content of this study and to record their symptoms in the 
health observation diary, and who have provided written consent to participate in this survey by 
themselves (or parents or legal guardians in the case of minors) 
 
2. 
Patients with an underlying disease considered to be at high risk of aggravation of COVID-19 at the 
time of vaccination with this product 
 
Underlying diseases considered to be at high risk of aggravation of COVID-19 are based on the range 
of patients with underlying diseases indicated by the Ministry of Health, Labour and Welfare for 
priority vaccination. In principle, the subjects will be identified by the doctor's confirmation through 
medical interview, etc. after the subjects have filled in the preliminary examination sheet about the 
underlying disease. 
 
Refer to the latest package insert of this product for "indications" and "dosage and administration" when 
this product is vaccinated. 
 
[Indications]                            Prevention of infection with SARS-CoV-2 
 
[Dosage and administration]   The   product   is   diluted   with   1.8 mL   of   Japanese   Pharmacopoeia 
physiological saline and administered intramuscularly at a dose of 0.3 mL 
2 times in total, usually at 3-week intervals. 
 
[Precautions regarding dosage and administration] 
Subjects:                       Those aged 12 years or older will be vaccinated with this product. 
Vaccination interval: If  3  weeks  or  more  have  passed  since  the  first  vaccination,  the  second 
vaccination should be given as soon as possible. 

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8.2.2. Exclusion criteria 
 
There are no exclusion criteria for this study. 
 
8.2.3. Study sites 
This study will be conducted at approximately 50 to 100 institutions with the system for vaccination with 
this product, which have agreed to cooperate with this investigation. 
 
8.2.4. Planned study period 
The planned period covered by this study is as follows. 
 
Investigation period:    From the date of start of the first vaccination of the first subject enrolled to 
the end of observation period for the last enrolled subject (scheduled from 
April 2021 to December 2021) 
 
Registration period:     From the date of start of the first vaccination of the first subject enrolled to 
the date of registration of the last enrolled subject (scheduled from April 2021 
to October 2021) 
 
The registration is terminated if the target number of the patients has been collected, even before the 
end of the registration period. 
 
8.2.5. Study procedures 
8.2.5.1. Study method 
Central registration system: This study will be conducted with Central registration system that patients 
who meet the conditions of this study will be registered until data are collected on a target number of 
patients. The investigator will investigate the subjects who meet the registration criteria (8.2.1) 
approximately within 21 days at the latest after the first vaccination with this product (before the second 
vaccination). 
 
This study will be conducted in patients who have been vaccinated with this product at contract sites after 
marketing approval. 
 
8.2.6. Observation period 
The observation period will be from the date of the first vaccination with this product (Day 1) to 28 days 
after the second vaccination. For the subjects who have received only the first vaccination and do not 
receive the second vaccination for some reason, the observation period will be until 28 days after the first 
vaccination. 
 
In this study, information will be collected using booklet type CRF. Information for the following periods 
will be entered in each booklet. 
 
 
Booklet 01: From the day of the first vaccination to the day before of the second vaccination 
 
(For the subjects who have received only the first vaccination with this product: Booklet 01, from 
the day of the first vaccination to 28 days after the first vaccination) 

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Booklet 02: From the day of the second vaccination to 28 days after the second vaccination 
 
However, in cases where treatment has been discontinued, observation is continued until discontinuation 
of treatment. 
 
8.3. Variable 
 
This study will be conducted according to the following schedule. 
 
Table 1. 
Variables 
 
 
Variable 
Registration 
form 
CRF 
Booklet 01 
CRF 
Booklet 02 
 
ID number                                                              
* 
Gender                                                                   
* 
Date of birth                                                           
* 
Eligibility                                                                
* 
Day of the first vaccination with this product                 
* 
Clinical history (concurrent illness/past history)                                              
Status of vaccination with this product (first)                                                   
Allergy information                                                                                          
History of other vaccinations                                                                            
Pregnancy and lactation (women only) 
Status of vaccination with this product (second)                                                                               
Information on inoculation of other vaccines                                                                                    
 
Concomitant medications 
 
Information on COVID-19 pathogen test 
 
Information on COVID-19 
Adverse events (including serious adverse 
events) 
End-of-study discontinuation record (reason)                                                  
* Some elements in the Registration Form are automatically reflected in the CRF. The investigators should check and 
update the CRF as needed. 
 
Figure 1. 
Schedule 
 
First vaccination 
Second vaccination*1 
 
CRF 
Booklet 01 
Booklet 02 
 
28 days after the 
second vaccination 
 
Entry in health observation 
diary 
 
Collection/verification of 
health observation diary 
 
8 days 
8 days 

COMIRNATY Intramuscular Injection 
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*1: For the subjects who have received only the first vaccination, the observation period will be until 28 days after the first 
vaccination, and Booklet 01 will be completed. 

COMIRNATY Intramuscular Injection 
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8.3.1. Characteristics of vaccinated subjects 
Enter the information at the time of first vaccination of this product in the registration form. 
 
 
ID number 
 
 
Gender 
 
 
Date of birth (if the date of birth cannot be provided, age at the first vaccination with this product) 
 
 
Date of the first vaccination with this product 
 
The following will be recorded in CRF at the time of the first vaccination with this product. 
 
 
Clinical history (concurrent illness and past history) 
 
The disease present at the time of vaccination with this product is considered as a "complication" 
and the disease present before vaccination with this product is considered as "medical history." 
 
 
Allergy information (information on presence/absence of allergy, type of allergy, and allergen) 
 
 
History of other vaccinations (presence or absence of vaccine and name of vaccine [within 2 
weeks before the date of the first vaccination with this product]) 
 
8.3.2. Pregnancy and lactation (women only) 
If the subject participating in this survey is female, the presence or absence of pregnancy and lactation 
during the period from the date of the first vaccination with this product to the target period of booklet will 
be entered. 
 
8.3.3. Status of vaccination with this product 
The following information will be recorded for the status of the first and second vaccination with this 
product. 
 
            Date of vaccination (The date of the first vaccination will be automatically reflected in the CRF.) 
 
            Lot number 
 
            Vaccination site 
 
8.3.3.1. Concomitant medications 
For drugs used concomitantly after the date of the first vaccination with this product and the drugs used for 
treatment of adverse events, enter the information to the end date of the observation period. 
 
            Drug name (product name) 
 
 
Treatment period (Enter the start date of treatment if no concomitant drugs are used as of the time of 
the first vaccination of this product, and enter the end date of treatment if no concomitant drugs are 
used at the end of the observation period.) 

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8.3.4. End-of-study/discontinuation record 
The investigator will enter the end date of the observation period (date of final observation) for each 
booklet, i.e., the day before of the second vaccination for Booklet 01 (28 days after the first vaccination [or 
thereafter] for the subjects who have received only the first vaccination) for Booklet 01, and the date of 
confirmation of information on the subject in the 28 days after the second vaccination (or thereafter) for 
Booklet 02. 
 
For confirmation of information of subjects, inquiries by telephone etc. are acceptable. 
 
If information on the subject cannot be confirmed even at 1 month after the end date of the observation 
period for each booklet, and the date of final confirmation of the information on the subject does not meet 
the observation period, the date on which information on the subject can be confirmed for the last time will 
be entered as the date of discontinuation of observation and the reason for discontinuation will be entered. 
(the subjects who have received only the first vaccination with this product will be handled as the cases of 
discontinuation). 
 
1.   Date of completion (discontinuation) of the observation period (date of final observation) 
 
2.   End of study or reason for discontinuation 
 
       End of study 
 
       Adverse events 
 
       Death 
 
       Lost to follow-up (including no visit after the date of the first vaccination with this product) 
 
       Consent withdrawal 
 
       Other 
 
8.3.5. Information on inoculation of other vaccines 
The investigator will confirm the presence or absence of vaccine inoculated during the observation period 
and enter the information. If a vaccine is inoculated during the observation period, the type of vaccine and 
the date of vaccination will be entered. 
 
8.3.6. Information on COVID-19 pathogen (SARS-CoV-2) test 
The investigator will confirm the presence or absence of the test for COVID-19 pathogen (SARS-CoV-2) 
received during the observation period and enter the information. If a pathogen test is performed, enter the 
date of test (date of specimen collection), type of test and test results in the CRF for each test. 
 
8.3.7. Information on COVID-19 
The investigator will confirm the presence or absence of the onset of COVID-19 during the observation 
period and enter the information. 
 
         Presence or absence of occurrence of COVID-19 
 
If The occurrence of COVID-19 is "present," the following information will also be entered. 

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            Date of diagnosis of COVID-19 
 
         Presence  or  absence  of  actions/procedures  taken  (hospitalisation,  oxygen  administration,  ICU 
admission, use of mechanical ventilation, and use of ECMO) 
 
 
Outcome (resolved/recovered, resolved with sequelae, death, not resolved, and unknown) and date of 
outcome 
 
The outcome should be followed up as much as possible after the end of the observation period. 
 
8.3.8. Adverse events 
Occurrence of adverse events from the date of the first vaccination with this product to the end date of 
observation period should be confirmed and the following information should be entered. The status of the 
subject should be examined for a certain period after each vaccination with this product. If acute reactions 
such as shock and anaphylaxis are observed, appropriate measures should be taken and the details should 
be recorded as adverse events. 
 
The information in the collected health observation diary (see Section 8.3.9) should be reviewed. If there 
are any records other than the symptoms at the vaccination site and general symptoms specified in the 
diary (including COVID-19 information), the details should be verified as needed, and should be entered 
as adverse events. The investigator does not need to enter the symptoms at the vaccination site (local 
reactions) and general symptom (systemic reactions) specified in the health observation diary in the CRFs 
to avoid overlapping with adverse events evaluated by physicians. 
 
Also, further investigation should be separately conducted, if deemed necessary by Sponsor for subjects 
who experienced a serious adverse reaction, or adverse reactions not listed in the package insert. 
 
         Presence/absence of adverse event 
 
         Name of adverse event 
 
         Severity 
 
         Date of occurrence 
 
         Presence or absence of treatment 
 
         Seriousness 
 
         Criteria for seriousness 
 
         Outcome (including the date of outcome) 
 
         Causal relationship to this drug 
 
8.3.8.1. Severity assessment (adverse events) 
The investigator will assess the maximum severity of adverse events and serious adverse events reported 
during the observation period from onset of adverse events to confirmation of outcome and classify them 
into one of the following categories. Severity is defined as follows. 

COMIRNATY Intramuscular Injection 
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Table 2. 
Definition of Severity 
 
Severity 
Definition 
Mild 
Not interfering with usual activities of vaccinated subjects 
Moderate 
Interfering with usual activities of vaccinated subjects to some 
extent 
Severe 
Markedly interfering with usual activities of vaccinated subjects 
 Life-th reaten in g  
Life-th reaten in g, or necessitatin g urgent intervention  
 
 
 
8.3.8.2. Criteria for seriousness 
The investigator will select and enter the applicable criteria for serious adverse events reported during the 
observation period. 
 
         Results in death. 
 
         Life-threatening 
 
         Requires hospitalisation or prolongation of existing hospitalisation 
 
         Results in persistent or significant disability/malfunction 
 
         Causes a congenital anomaly/birth defect. 
 
         Other medically important events 
 
8.3.9. Health observation diary 
A health observation diary will be distributed to the subjects participating in this study and they will be 
requested  to  record  information  on  symptoms  at  the  vaccination  site  (local  reactions)  and  general 
symptoms (systemic reactions [including pyrexia]) after vaccination with this product. Study participants 
will examine and record local reactions (injection site pain, redness, and swelling) and systemic reactions 
(pyrexia, vomiting, diarrhoea, headache, Fatigue, chills, myalgia, and arthralgia) in the diary for 8 days 
after vaccination with this product (If the symptoms persist even on the 9th day or thereafter, the date of 
disappearance of the symptoms should be recorded.). 
 
The investigator will collect the health observation diary after the end of the observation period (collection 
by mail is also acceptable) and check the details of the information other than the symptoms at the 
vaccination site and general symptoms recorded in the diary (including the COVID-19 information) as 
needed (or confirm by telephone, etc.) and enter them as adverse events. The investigator does not need to 
enter the symptoms at the vaccination site (local reactions) and general symptom (systemic reactions) 
specified in the health observation diary in the CRFs to avoid overlapping with adverse events evaluated 
by physicians. 
 
The  investigator  will  replace  the  information  with  a  single,  specific,  numerical  code  based  on  the 
numbering system specified by the sponsor, and submit a copy of the diary to the sponsor or other 
authorized persons concerned (in principle, submit by mail). 

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8.3.9.1. Severity assessment (health observation diary) 
The severity used by the subjects when evaluating symptoms at the vaccination site (local reactions) and 
general symptoms (systemic symptoms [including pyrexia]) will be recorded in the health observation 
diary by using the following indices. 
 
The severity classification will be set based on the “Food and Drug Administration. Guidance for industry: 
toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical 
trials.” In the diary, expressions which are easy to understand and correspond with each grade will be used 
(not interfering with activities = no change in daily life, interfering with activities = influence on daily life, 
interference with daily activities = making daily life difficult). 
 
Table 3. Severity Classification of Local Reactions 
 
Mild 
Grade 1 
 
 
Moderate 
Grade 2 
 
 
Severe 
Grade 3 
Injection site pain 
Not interfering with 
activities 
Interfering with activities 
Interfering with daily 
activities 
Redness 
2.0～5.0cm 
>5.0～10.0cm 
>10.0 cm 
Swelling 
2.0～5.0cm 
>5.0～10.0cm 
>10.0 cm 
 
 
 
 
Table 4. Severity Classification of Systemic Reactions 
 
Mild 
Grade 1 
 
 
Moderate 
Grade 2 
 
 
Severe 
Grade 3 
Vomiting 
1 or 2 times within 24 
hours* 
 
Diarrhoea 
2 to 3 episodes of faeces 
soft within 24 hours* 
 
Headache 
Not interfering with 
activities 
Fatigue 
Not interfering with 
activities 
Chills 
Not interfering with 
activities 
Myalgia 
Not interfering with 
activities 
Arthralgia 
Not interfering with 
activities 
* "Within 24 hours" was "1 day" in the diary. 
3 times or more within 
24 hours* 
 
4 to 5 episodes of faeces 
soft within 24 hours* 
 
Slightly interfering with 
activities 
Slightly interfering with 
activities 
Slightly interfering with 
activities 
Slightly interfering with 
activities 
Slightly interfering with 
activities 
Intravenous fluid 
replacement (drip 
infusion )** 
6 or more episodes of 
faeces soft within 24 
hours* 
Interfering with daily 
activities 
Interfering with daily 
activities 
Interfering with daily 
activities 
Interfering with daily 
activities 
Interfering with daily 
activities 
** "Intravenous fluid replacement (drip infusion)" was "drip infusion" in the diary. 
 
8.4. Data sources 
In this study, the investigator will extract necessary information based on the full protocol from the 
information obtained by the preliminary examination sheet and the health observation diary completed by 
the study participants, as well as by medical interview, etc. and the records including medical records. 

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Evaluation of local reactions and systemic reactions after vaccination recorded by subjects in the health 
observation diary will be used. 
 
8.5. Study size 
8.5.1. Planned sample size 
 
1,000 subjects will be collected as the subjects to be included in the safety analysis set. 
 
8.5.2. Rationale for sample size 
Considering the timing of vaccination for individuals with underlying diseases who are considered to be at 
high risk of aggravation of COVID-19, the timing of implementation of this study is believed to be limited. 
In addition, because it is planned in this study to provide information for obtained informed consent to the 
subjects, to request for entry in the health observation diary, and to collect the diary, it will cause a great 
burden on medical institutions. From the viewpoint of feasibility, the target number of subjects was set at 
1,000. 
If 1,000 subjects who have received vaccination with this product at least once can be collected, an event 
that occurs with a true probability of 0.3% can be observed in at least 1 subject with a probability of 95%. 
In addition, based on the results of the safety analysis for the at risk population in Study C4591001, it is 
assumed that the safety profile will not differ between the population of subjects aged 56 years or older 
and the population with underlying disease that is considered to be at high risk of aggravation of COVID- 
19. 
 
 
Based on the safety data obtained so far in the population aged 56 years or older in Study C4591001, the 
incidence of severe adverse events that occurred after vaccination with this product ranged from 0.1% 
(vomiting and diarrhoea) to 2.8% (fatigue), and therefore it is considered possible to confirm these events 
by collecting the safety information of 1,000 subjects. 
 
 
 
8.6. Data management 
8.6.1. Case report forms (CRFs)/Electronic data record 
The term CRF in this full protocol refers to an electronic data record corresponding to the data collection 
method used in this study. 
 
A CRF is required and should be completed for each included subject. The completed original CRFs are 
the sole property of Pfizer and should not be made available in any form to third parties, except for 
authorized representatives of Pfizer or appropriate regulatory authorities, without written permission from 
Pfizer. The investigator shall ensure that the CRFs are securely stored at the study site in the encrypted 
electronic form and will be password protected or secured in a locked room to prevent access by 
unauthorized third parties. 
 
The investigator has ultimate responsibility for the collection and reporting of all clinical, safety, and 
laboratory data entered on the CRFs and any other data collection forms (source documents) and ensuring 
that they are accurate, authentic/original, attributable, complete, consistent, legible, timely 
(contemporaneous), enduring, and available when required. The CRFs must be signed by the investigator 
or by an authorized staff member to attest that the data contained on the CRFs are true.  Any corrections to 
entries made in the CRFs or source documents must be dated, initialed (or stamped "correction seal"), and 
explained (if necessary) and should not obscure the original entry. 

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In most cases the source documents are the hospital or the physician's chart. In these cases, data collected 
on the CRFs must match those charts. 
 
In some cases, the CRF may also serve as the source document. In these cases, a document should be 
available at the investigator site and at Pfizer that clearly identifies those data that will be recorded on the 
CRF, and for which the CRF will stand as the source document. 
 
8.6.2. Record retention 
 
The records related to this study should be retained at the study site until the End of Study Letter by Pfizer 
is received or during the period defined by the study site, whichever is longer. 
 
8.6.3. Data collection method 
8.6.3.1. Care report form (EDC) 
The data for this study will be collected and confirmed by using the electronic system on the internet 
designed for collecting post-marketing survey data (Electronic Data Capture, EDC). 
 
8.6.3.2. Health observation diary 
The participants in this study will be asked to fill out the health observation diary for 8 days after each 
vaccination (if symptoms continue on the 9th day or thereafter, the date of disappearance of the symptoms 
should be recorded). The investigator will collect the health observation diary at the time of the second 
vaccination  with  this  product  and  28  days  after  the  second  vaccination  (at  28  days  after  the  first 
vaccination for the subjects who have received only the first vaccination) from the study participants and 
review the contents of the health observation diary. After that, the investigator will anonymize the names 
of the study participants and replace information with a single unique numerical code based on the 
numbering method specified by the sponsor to protect personal data of study participants, and submit a 
copy of the diary to the sponsor or other authorized personnel (in principle, submit it by mail). 
 
8.6.4. Subject registration (EDC) 
The investigator will enter information on the registration screen of EDC (registration form) for the 
subjects to be studied and save the data. Subject registration will be performed within 21 days at the latest 
after the first vaccination with this product (before the second vaccination). 
 
8.6.5. Points to consider for completion, revision, and submission of case report form (EDC) 
 
8.6.5.1. Data entry 
The investigator will check the survey items and enter the data in the EDC based on the information such 
as the preliminary examination sheet completed by the subjects, records including medical records, and 
information in the health observation diary. 
 
For the symptoms at the vaccination site (local reactions) and general symptoms (systemic reactions) 
specified in the health observation diary, the sponsor will enter the data in the EDC based on the copy 
submitted by the investigator. 
 
8.6.5.2. Data revision 
Upon receiving query from Sponsor on the contents of the CRF (follow-up survey), the investigator will 
again confirm the contents of medical records, and as required, correct relevant sections and save the data. 

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3. Since this study collects the information from medical interview based on the preliminary examination 
sheet and health observation diary and records such as medical records, specified data may not be 
collected or may be missing. 
 
8.10. OTHER NECESSARY MATTERS 
Not applicable. 
 
9. PROTECTION OF HUMAN SUBJECTS 
9.1. Information of vaccinated subjects 
All parties will comply with all applicable laws, including laws regarding the implementation of 
organizational and technical measures to ensure protection of personal data of subjects. Such measures 
will include omitting subject names or other directly identifiable data in any reports, publications, or other 
disclosures, except where required by applicable laws. The personal data will be stored at the study site in 
encrypted electronic and/or paper form and will be password protected or secured in a locked room to 
ensure that only authorized study staff have access. The study site will implement appropriate technical 
and organizational measures to ensure that the personal data can be recovered in the event of disaster. In 
the event of a potential personal data breach, the study site shall be responsible for determining whether a 
personal data breach has in fact occurred and, if so, providing breach notifications as required by law. 
 
To protect the rights and freedoms of natural persons with regard to the processing of personal data, when 
study data are compiled for transfer to Pfizer and other authorized parties, subject names will be removed 
and will be replaced by a single, specific, numerical code, based on a numbering system defined by Pfizer. 
All other identifiable data transferred to Pfizer or other authorized parties will be identified by this single, 
subject-specific code. The investigator site will maintain a confidential list of subjects who participated in 
the study, linking each subject's numerical code to his or her actual identity. In case of data transfer, Pfizer 
will maintain high standards of confidentiality and protection of subjects' personal data consistent with the 
clinical study agreement and applicable privacy laws. 
 
9.2. Consent of vaccinated subjects 
The informed consent documents must be in compliance with local regulatory requirements and legal 
requirements, including applicable privacy laws. 
 
The  informed  consent  documents  used  during  the  informed  consent  process  must  be  reviewed  and 
approved by Pfizer, approved by the institutional review board (IRB)/independent ethics committee (IEC) 
before use, and available for inspection. 
 
The investigator must ensure that each subject, or his or her legally acceptable representative, or parent(s) 
or legal guardian if a minor, is fully informed about the nature and objectives of the study, the sharing of 
data relating to the study and possible risks associated with participation, including the risks associated 
with the processing of the subject's personal data. The investigator further must ensure that each subject, or 
his or her legally acceptable representative, or parent(s) or legal guardian if a minor, is fully informed 
about his or her right to access and correct his or her personal data and to withdraw consent for the 
processing of his or her personal data. 
 
Whenever consent is obtained from a subject's legally acceptable representative/parent(s) or legal guardian 
if a minor, the subject's assent (affirmative agreement) must subsequently be obtained when the subject 
has the capacity to provide assent, as determined by the IRB/IEC. If the investigator determines that a 
subject's decisional capacity is so limited that he or she cannot reasonably be consulted, then, as permitted 
by the IRB/IEC and consistent with local regulatory and legal requirements, the subject's assent may be 

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waived with source documentation of the reason assent was not obtained. If the subject does not provide 
his or her own consent, the source documents must record why the subject did not provide consent (e.g., 
minor, decisionally impaired adult), how the investigator determined that the person signing the consent 
was the subject's legally acceptable representative, the consent signer's relationship to the subject (e.g., 
parent, spouse), and that the subject's assent was obtained or waived. If assent is obtained verbally, it must 
be documented in the source documents. 
 
If the study includes minor subjects who reach the age of majority during the study, as recognized under 
local law, they must re-consent as adults to remain in the study. If the enrollment of emancipated minors is 
permitted by the study age criteria, the IRB/IEC, and local law, they must provide documentation of legal 
status to give consent without the permission of parents or legal guardian. 
 
The investigator, or a person designated by the investigator, will obtain written informed consent from 
each subject or the subject's legally acceptable representative, parent(s), or legal guardian if a minor, 
before any study‑specific activity is performed. The investigator will retain the original of each subject's 
signed consent document. 
 
9.3. Subject withdrawal 
Study participants  may withdraw  from the  study at  any time  at  their  own  request,  or  they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or 
administrative reasons.   In any circumstance, every effort should be made to document the outcome of 
study participants, if applicable. The investigator would inquire about the reason for withdrawal and 
follow-up with the subject regarding any unresolved adverse events. 
 
If the study participant withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be collected. The 
sponsor may retain and continue to use any data collected before such withdrawal of consent. 
 
9.4. Institutional review board (IRB)/Independent ethics committee (IEC) 
The  informed  consent  documents  used  during  the  informed  consent  process  must  be  reviewed  and 
approved by Pfizer, approved by the institutional review board (IRB)/independent ethics committee (IEC) 
before use. 
 
9.5. Ethical conduct of the study 
This study will be conducted in compliance with the "MHLW Ordinance on the Standard for Post- 
Marketing Studies and Clinical Trials of Medical Products" (MHLW Ordinance No. 171, dated December 
20, 2004) Also, the study will be conducted in accordance with legal and regulatory requirements, as well 
as with scientific purpose, value and rigor. 
 
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS 
 
10.1. Record and report requirements 
The following table summarizes the requirements for recording safety events on CRFs and for reporting 
safety events to Pfizer Safety on a Non-Interventional Study Adverse Event Report Form (NIS AE Report 
Form). These requirements are described for three types of events as follows: (1) serious adverse events, 
(2) non-serious adverse events (if applicable), and (3) drug exposure-related scenarios including exposure 
during pregnancy, exposure during breast feeding, medication error, drug overdose, drug misuse, 
extravasation, lack of efficacy, and occupational exposure. These events are defined in the section of 
“Safety event definition.” 

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Safety event 
Record in CRF. 
Report to Pfizer Safety 
within 24 hours of 
awareness of the event 
using the NIS AE Report 
Form. 
Serious adverse events 
All 
All 
Non-serious adverse events 
All 
None 
Scenarios related to exposure to 
this product including exposure 
during pregnancy, exposure during 
breast feeding, medication error, 
drug overdose, drug misuse, 
extravasation, lack of efficacy, 
occupational exposure 
All (with or without adverse 
events), expect occupational 
exposure 
All (with or without adverse 
events) 
Note: All adverse events 
related to drug 
administration will be 
reported with exposure 
scenarios. 
 
For each adverse event, the investigator must obtain information adequate for confirming the outcome, and 
determining whether the event meets the criteria for a serious adverse event (see the section of "Serious 
adverse events" below). 
 
The safety events for which reporting to the Safety division is required in the above table must be reported 
to Pfizer within 24 hours of the investigator's awareness of the event, regardless of whether the event is 
determined by the investigator to be related to this product. In particular, if the serious adverse event 
is fatal or life-threatening, notification to Pfizer must be made immediately, irrespective of the extent of 
available  information.  This  timeframe  also  applies  to  additional  new  (follow-up)  information  on 
previously forwarded safety event reports. In the rare event that the investigator does not become aware of 
the occurrence of a safety event immediately, the investigator is to report the event within 24 hours after 
learning of it and record the day and time of his/her first awareness of the event. 
For those safety events that are considered serious or that are specified in the far right column of the table 
above as requiring reporting to Pfizer within 24 hours of awareness, the investigator must conduct the 
follow-up investigation, and must provide any additional information to Pfizer in accordance with the 24- 
hour timeframe. In addition, an investigator may be requested by Pfizer to obtain specific additional 
information in an expedited fashion. This information needs to be more detailed than that recorded on the 
CRF. In general, this information should include sufficient detail to allow for a complete medical 
assessment of the event and independent determination of causality. Information regarding this event, such 
as concomitant medications and illnesses, must also be provided. In the event of a subject's death, a 
summary of available autopsy findings must be submitted as soon as possible to Pfizer or its designated 
representative. 
 
10.2. Reporting period 
The reporting period of safety events (see the table above) in each subject to Safety division begins with 
the first vaccination with this product to the subjects and ends at the end of the observation period in the 
study. However, the period of at least 28 calendar days after the final vaccination with this product should 
be the reporting period. If a safety event of the type described in the table above has occurred during the 
reporting period, the investigator will submit a report to Pfizer Safety (or its designated representative). If 
a subject has been vaccinated with this product on the last day of the observation period, the reporting 
period should be extended by 28 calendar days after the end of the observation period. In most cases, the 
date of informed consent is the same as the date of enrollment. In some circumstances, there may be a 
difference between the date of informed consent and the date of enrollment. The reporting period will end 

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on the day the decision is made not to include the vaccinated subject if a subject has given consent but is 
not enrolled in the study (e.g., the subject has changed his/her intention to participate in the study). 
If the investigator becomes aware of the occurrence of a serious adverse event at any time after completion 
of the study and the serious adverse event is determined to be related to this product, the serious adverse 
event will also be reported to Pfizer Safety. 
 
10.3. Evaluation of causal relationship 
The investigator will be asked to evaluate and record the causal relationship. In addition, the investigator 
should obtain sufficient information to assess the causal relationship of each adverse event. For adverse 
events related to this product, follow-up investigation by the investigator is required until the event or its 
sequelae resolves or stabilizes at a level acceptable to the investigator, and Pfizer concurs with that 
assessment. 
 
The evaluation of the causal relationship by the investigator will be determined by whether there exists a 
reasonable possibility that the drug has caused or contributed to the adverse event. If the investigator’s 
final judgement regarding the causal relationship is "unknown," and it cannot be decided whether this 
product has caused the event, the safety event must be reported within 24 hours. 
 
If the investigator cannot identify the cause of the event, but judges that this product has not caused the 
event, it should be clearly stated in the CRF and the NIS AE Report Form. 
 
10.4. Safety event definition 
10.4.1. Adverse events 
An  adverse  event  is  an  untoward  medical  occurrence  in  a  vaccinated  subject.  The  event  does  not 
necessarily have a causal relationship with inoculation or use of the product. Examples of adverse events 
include, but are not limited to: 
 
 
Abnormal test findings (see below for circumstances in which an abnormal test finding constitutes an 
adverse event) 
 
         Clinically significant symptoms and signs 
 
         Changes in physical examination findings 
 
         Hypersensitivity 
 
         Progression/worsening of underlying disease 
 
         Lack of efficacy 
 
         Drug abuse 
 
         Drug dependence 
 
In addition, they may include signs and symptoms resulting from: 
 
         Drug overdose 
 
         Drug withdrawal 

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Drug misuse 
 
 
Off label use 
 
 
Drug interaction 
 
 
Extravasation 
 
 
Exposure during pregnancy 
 
 
Exposure during breast feeding 
 
 
Medication error 
 
 
Occupational exposure 
 
Abnormal test findings 
 
The criteria for determining whether an abnormal test finding should be reported as an adverse event are as 
follows: 
 
         The test result is accompanied by associated symptoms. 
 
         Additional diagnostic testing or medical/surgical intervention is required. 
 
 
The test result leads to a change in administration of this product, discontinuation of the study, or 
addition of concomitant drug treatment or other therapy. 
 
         The investigator or Pfizer regards the test result as an adverse event. 
 
A case in which none of the above situations is present but simply an abnormal value continues will not be 
regarded as an adverse event. Any abnormal test result that is determined to be due to a laboratory error 
does not require reporting as an adverse event. 
 
10.4.2. Serious adverse events 
A serious adverse event is any untoward medical occurrence in a subject who has received a medicinal or 
nutritional product (including pediatric formulas) at any dose that: 
         Results in death. 
 
         Life-threatening 
 
 
Requires hospitalisation or prolongation of existing hospitalisation (see below for circumstances in 
which an abnormal test finding does not constitute an adverse event). 
 
 
Results  in  persistent  or  significant  disability/malfunction  (substantial  disruption  of  the  ability  to 
conduct normal life functions). 
 
         Causes a congenital anomaly/birth defect. 

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Medical and scientific judgment should be exercised in deciding whether an event is a medically important 
event. Significant medical events may not be immediately life-threatening or result in death or 
hospitalisation. However, if it is determined that the event may jeopardize the subject or may require 
intervention to prevent one of the other outcomes listed in the definition above, the event should be 
reported as serious. 
 
Examples of such events are intensive care in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency 
or drug abuse. 
 
In addition, any suspected transmission via a Pfizer product of an infectious agent, pathogenic or 
nonpathogenic, is considered serious. The onset of the event may be suspected from clinical signs or 
laboratory findings suggestive of infection in a subject exposed to a Pfizer product. The term "suspected 
transmission" is considered the synonym of "transmission." These cases are considered unexpected and 
will be handled as serious expedited cases by Safety division. Such cases should also be considered for 
reporting as product defects, if appropriate. 
Hospitalisation 
 
Hospitalisation is defined as any initial admission (even less than 24 hours) to a hospital or equivalent 
healthcare facility or any prolongation of existing hospitalisation. Hospitalisation also includes transfer 
within the hospital to another department or an acute/intensive care unit (e.g., from the psychiatric floor to 
the medical floor, from the medical floor to the coronary care unit, from the neurological floor to the 
tuberculosis unit, etc.). A visit to the emergency room is not necessarily regarded as hospitalisation; 
however, the event leading to the emergency room visit should be assessed for medical significance. 
 
Hospitalisation without a medical adverse event is not an adverse event itself and reporting is not required. 
For example, hospitalisation without any of the following medical adverse events does not require 
reporting. 
 
         Hospitalisation for social reasons (e.g., no place of accommodation for subjects) 
 
         Administrative hospitalisation (e.g., for yearly physical examination) 
 
 
Optional hospitalisation not associated with a precipitating clinical illness (e.g., for elective cosmetic 
surgery) 
 
         Hospitalisation for observation without a medical adverse event 
 
 
Hospitalisation for treatment of a preexisting condition not associated with the occurrence of a new 
adverse  event  or  with  worsening  of  the  preexisting  condition  (e.g.,  for  precise  examination  of 
abnormal laboratory test values observed before the start of the treatment) 
 
 
Hospitalisation during the investigation period specified in the full protocol (e.g. tests and procedures 
specified in the protocol) 
 
10.4.3. Scenarios necessitating reporting to Pfizer Safety within 24 hours 
Scenarios related to exposure during pregnancy, exposure during breast feeding, medication error, drug 
overdose, drug misuse, extravasation, lack of efficacy, and occupational exposure are described below. 

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Exposure during pregnancy 
 
Exposure during pregnancy (EDP) occurs when: 
 
3. A female becomes, or is found to be, pregnant either while receiving or being exposed to this product 
(e.g., environmental exposure). A female becomes, or is found to be, pregnant after discontinuing or 
having been directly exposed to this product (maternal exposure). 
 
An example of environmental exposure would be a case involving direct contact with a Pfizer product in a 
pregnant woman (e.g., a nurse reports that she is pregnant and has been exposed to chemotherapeutic 
products). 
 
4. A male has been exposed, either due to treatment or environmental exposure, to a Pfizer product prior 
to or around the time of conception. A male has been exposed during his partner's pregnancy (paternal 
exposure). 
 
As a general rule, prospective and retrospective reports of exposure during pregnancy from any source are 
reportable irrespective of the presence of an associated adverse event and the procedures for reporting 
serious adverse events should be followed. 
 
If a subject or a subject's partner becomes or is found to be pregnant during the period of treatment with 
this product, this information must be submitted to Pfizer, irrespective of whether an adverse event has 
occurred, using the NIS AE Report Form and the EDP Supplemental Form. 
 
In addition, information regarding environmental exposure to this product in pregnant women (e.g., a 
subject reports that she is pregnant and has been exposed to a cytotoxic product by inhalation or spillage) 
must be submitted using the NIS AE Report Form and the EDP Supplemental Form. This must be done 
irrespective of whether an adverse event has occurred. 
 
The information submitted should include the anticipated date of delivery (see below for information on 
termination of pregnancy). 
 
Follow-up investigation should be conducted to obtain general information on the pregnancy. In addition, 
follow-up investigation of EDP outcome information is required for all EDP reports with an unknown 
pregnancy outcome. The pregnancy will be followed until completion or until pregnancy termination (e.g., 
abortion induced) and the outcome should be reported to Pfizer. This information should be submitted as 
the follow-up investigation of the initial EDP report. In the case of a live birth, the absence of external 
malformations should be evaluated at birth. In the event of a termination, the reason(s) for termination 
should be specified and, if clinically possible, the structural integrity of the terminated fetus should be 
assessed by gross visual inspection (unless pre-procedure test findings are conclusive for a congenital 
anomaly and the findings are reported). 
 
If the outcome of the pregnancy meets the criteria for a serious adverse event (ie, extrauterine pregnancy, 
abortion spontaneous, foetal death in utero, death neonatal, or congenital anomaly [in live-born baby, 
terminated fetus, foetal death in utero, or death neonatal]), the procedures for reporting serious adverse 
events should be followed. 
 
Additional information on pregnancy outcomes that are reported as serious adverse events is as follows: 
 
         Abortion spontaneous includes abortion and abortion missed. 

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Death neonatal that occurs within 1 month of birth should be reported as a serious adverse event, 
irrespective of causality. In addition, infant deaths after 1 month should be reported as serious adverse 
events when the investigator assesses the infant death as related or possibly related to exposure to the 
investigational product. 
 
Additional information on exposure during pregnancy may be requested. Further follow-up of birth 
outcomes will be handled on a case-by-case basis (e.g., follow-up on premature babies to identify 
developmental delays). 
 
In the case of paternal exposure, subjects will be provided with a document on "Disclosure of Information 
on Pregnant Partners," which is to be given to their partners. It must be documented that this document to 
be given to his partner has been provided to the subject. 
 
Exposure during breast feeding 
 
Scenarios  involving  exposure  during  breastfeeding  must be  reported,  irrespective  of  the  presence  or 
absence of an associated adverse event. A report of exposure during breast feeding will not be prepared 
when  a  Pfizer  product  specifically  approved  for  use  in  breastfeeding  women  (e.g.,  vitamins)  is 
administered in accordance with authorized use. However, if an infant experiences an adverse event 
associated with the use of these agents, the adverse event should be reported along with the exposure 
during breastfeeding. 
 
Medication error 
 
A medication error is any preventable event which may cause or lead to inappropriate use of a medicinal 
product under the control of the healthcare professional, subject, or consumer, or cause adverse effect in 
subject. Such events may be related to the medical practice, product, procedure, or system, including 
prescription, delivery of prescribing information, product labeling, packaging and name, compounding, 
dispensing, distribution, administration, education, monitoring, and use. 
 
Examples of medication errors include: 
 
Medication  errors  prevented  in  advance,  irrespective  of  whether  or  not  having direct  effects  on 
subjects (e.g., inadvertent/incorrect administration by a healthcare professional or subject/consumer 
using the product incorrectly at an administration method or dose level not indicated on the product 
label or prescription). 
 
         Confusion of names (e.g., trade name) 
 
The investigator must submit the following medication errors irrespective of the presence or absence of 
associated adverse events/serious adverse events: 
 
 
Medication errors involving subject exposure to the product, whether or not the medication error is 
accompanied by an adverse event 
 
 
Medication errors that do not involve a subject directly (e.g., possible medication errors or near misses, 
including potential ones or those prevented in advance). If the medication error does not involve 
subject exposure to the product, a medication error report will be created based on the following 
minimum criteria: 
 
 
Identifiable reporter 

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Suspected product 
 
 
Medication error events 
 
Drug overdose, drug misuse, and extravasation 
 
The investigator must report drug overdose, misuse, and extravasation associated with the use of a Pfizer 
product to Pfizer, irrespective of the presence or absence of adverse events/serious adverse events. 
 
Lack of efficacy 
 
The investigator must report lack of efficacy of Pfizer products to Pfizer, irrespective of the presence or 
absence of adverse events/serious adverse events, and the indication of the Pfizer product. 
 
Occupational exposure 
 
The  investigator  must  report  occupational  exposure  to  Pfizer  products  to  Pfizer,  irrespective  of  the 
presence or absence of adverse events/serious adverse events. 
 
10.5. Single Reference Safety Document 
In this study, the package insert of this product in Japan will serve as the Single Reference Safety 
Document. This document will be used by Pfizer Safety to assess any safety events reported to Pfizer 
Safety by the investigator during the course of this study. 
 
Single reference safety document should be used by the investigator for prescribing purposes and guidance. 
 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
Information collected in this study will be used for reporting purposes to Ministry of Health, Labour and 
Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), Pfizer Inc. which is the 
corporate parent of the sponsor of this study, and the group companies, or regulatory agency in other 
countries. Also, it will be used for submitting application of re-examination (including Japan Periodic 
Safety Update Report), re-evaluation, preparation of material for proper use information of this drug, 
publications and activities for information provision. In addition, Pfizer may disclose the study results to 
provide information for proper use, as needed, on www.clinicaltrials.gov (ClinicalTrials.gov), publish as 
presentations at academic conferences or, as manuscripts, etc. 
 
Data obtained from the subjects registered in this Study will be reported to the MHLW pursuant to the 
Pharmaceutical and Medical Device Act. In this case, the data may be publicly posted in MHLW's 
"Pharmaceutical and Medical Device Safety Information" and "Pharmaceuticals and Medical Devices 
Information Website (http://www.info.pmda.go.jp)" as a listing of subjects, which will include the names 
of drugs, adverse reactions, gender, age (increment of 10 years), and other relevant information. 
Furthermore, data collected may also be disclosed if the MHLW is required to disclose such information in 
accordance with the "Act on Access to Information Held by Administrative Organs" (Law No. 42 dated 
May 14, 1999); provided that in no event will the names of physicians, medical institutions, and other 
personal information be subject to such disclosure, nor will it be posted or disclosed. 
 
In the event of any prohibition or restriction imposed (e.g., clinical hold) by an applicable Competent 
Authority in any area of the world, or if the investigator is aware of any new information which might 
influence the evaluation of the benefits and risks of a Pfizer product, Pfizer should be informed 
immediately. 

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In addition, the investigator will inform Pfizer immediately of any urgent safety measures taken by the 
investigator to protect the subjects against any immediate hazard, and of any serious breaches of this NI 
study full protocol that the investigator becomes aware of. 
 
12. ORGANIZATIONAL SYSTEM FOR STUDY IMPLEMENTATION 
Refer to the appendix 1 of the risk management plan "Organizational system for study implementation". 
 
13. NAME, AND ADDRESS OF CONTRACTOR AS WELL AS SCOPE OF WORK 
CONTRACTED 
            Company name: Pfizer R&D Japan 
Address: Shinjuku Bunka Quint Bldg., 3-22-7, Yoyogi, Shibuya-ku, Tokyo 
Scope of work of contracted: Works related to planning of study, drafting of plan and implementation 
of study, etc. 
 
            Company name: Medidata Solutions 
Address: JP Tower 29th Floor, 2-7-2, Marunouchi, Chiyoda-ku, Tokyo 
Scope of work contracted: Support of establishment, operation and maintenance of the EDC system, 
etc. 
 
            Company name: EPS Corporation 
Address: 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo 
Scope   of   work   contracted:   Monitoring   operations,   registration   reception   operations,   health 
observation diary reception operations, data management operations (including EDC construction), 
statistical analysis operations, etc. 
 
 
14. ADDITIONAL MEASURES THAT MAY BE TAKEN BASED ON THE STUDY RESULTS 
AND CRITERIA FOR DETERMINATION OF THE INITIATION 
Review the risk management plan including the following contents at the scheduled timing of milestones. 
 
1. Review the necessity for changing the contents of risk minimization activities for the current safety 
specifications. 
 
2. Review the necessity for changing the contents of this study plan including the presence or absence of 
new safety specifications (continuation of the study, implementation of additional study, etc.). 
 
3.   Review the necessity for formulating risk minimization measures for new safety specifications. 
 
15. SCHEDULED TIMING OF MILESTONES AND THEIR RATIONALES FOR EVALUATION 
OF STUDY IMPLEMENTATION STATUS AND RESULTS AND REPORTING TO THE PMDA 
 
To be determined 
 
16. OTHER NECESSARY MATTERS 
1.   Revision of full protocol 
 
Based  on  the  new  knowledge  to  be  obtained  according  to  the  progress  of  this  study,  the  need  for 
amendment of the full protocol will be examined and the full protocol will be amended if necessary. Also, 
the need for amendment of the full protocol will be examined and the full protocol will be amended when 

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20. LIST OF FIGURES 
 
Page12. Figure 1. 
Schedule 
 
APPENDIX 1. LIST OF STAND ALONE DOCUMENTS 
Not applicable. 
 
APPENDIX 2. ADDITIONAL INFORMATION 
 
1. 
Registration forms for special investigation 
 
2. 
Case report forms for special investigation 
 
3. 
Health observation diary for special investigation health 

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