Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
Conditions: COVID-19
Sponsor: Pfizer

BNT162b2 mRNA Vaccine 
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STUDY PROTOCOL 
 
 
Study information 
 
Title 
Safety Profile of BNT162b2 mRNA SARS-Cov-2 
Vaccine in Indonesia: A National Passive 
Surveillance. 
Protocol number 
C4591050 
Protocol version identifier 
Version 2.0 
Date 
26 April 2023 
Active substance 
ATC code: J07BX03 
Tozinameran - Nucleoside-modified messenger 
RNA (modRNA) encoding the viral spike 
glycoprotein (S) of SARS-CoV-2 
Medicinal product 
BNT162b2 mRNA Vaccine 
Research question and objectives 
The objective of the study is to characterize 
descriptively the BNT162b2 vaccination 
experience among the Indonesian population, by 
analyzing structured data within Indonesia 
Vaccine Safety Databaseas requested by 
Indonesia Food and Drug Monitoring Agency 
(BPOM). 
Specific data elements include: 
A. Primary outcome measure : 
A1. SAE (Serious Adverse Event) : SAE 
after primary dose and/or booster dose 
A2. Total AE reported after primary 
dose and/or booster dose 
B. Secondary outcome measure : 
B1. SAE onset : ≤30 mins or > 30 mins 
 
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B2. Causality of SAE : coincidence, 
ISRR (Immunization Stress Related 
Response), vaccine reaction, 
unclassifiable, or indeterminate 
B3. Type of AE : 
B3.1. Serious and Non-serious 
B3.2. Solicited and unsolicited 
B4. Solicited AEs: 
B4.1.. Local reactions : pain, 
swelling, redness, thickness. 
B4.2. Systemic reactions: fever, 
myalgia, malaise 
B5. Unsolicited AEs: 
B5.1. Local reactions: abscess, 
bleeding, etc. 
B5.2. Systemic reactions: headache, 
nausea, arthralgia, etc. 
Author 
PPD 
MD 
Pfizer 
PPD 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1. TABLE OF CONTENTS 
1. TABLE OF CONTENTS .......................................................................................................3 
2. LIST OF ABBREVIATIONS ................................................................................................5 
3. RESPONSIBLE PARTIES ....................................................................................................7 
4. ABSTRACT ...........................................................................................................................8 
5. AMENDMENTS AND UPDATES .......................................................................................8 
6. MILESTONES .......................................................................................................................9 
7. RATIONALE AND BACKGROUND ..................................................................................9 
8. RESEARCH QUESTION AND OBJECTIVES ..................................................................10 
9. RESEARCH METHODS .....................................................................................................10 
9.1. Study design ............................................................................................................10 
9.2. Setting ......................................................................................................................11 
9.2.1. Inclusion criteria..........................................................................................12 
9.2.2. Exclusion criteria ........................................................................................12 
9.3. Variables ..................................................................................................................12 
9.4. Data sources .............................................................................................................13 
9.5. Study size .................................................................................................................13 
9.6. Data management ....................................................................................................14 
9.7. Data analysis ............................................................................................................14 
9.8. Quality control .........................................................................................................14 
9.9. Limitations of the research methods ........................................................................14 
9.10. Other aspects ..........................................................................................................14 
10. PROTECTION OF HUMAN SUBJECTS .........................................................................15 
10.1. Patient information ................................................................................................15 
10.2. Patient consent .......................................................................................................15 
10.3. Patient withdrawal .................................................................................................15 
10.4. Institutional review board (IRB)/Independent ethics committee (IEC) .................15 
10.5. Ethical conduct of the study ..................................................................................15 
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS .......................................................................................................................16 
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS ........17 
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13. REFERENCES ................................................................................................................... 17 
14. LIST OF TABLES ............................................................................................................. 18 
15. LIST OF FIGURES ............................................................................................................ 18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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2. LIST OF ABBREVIATIONS 
 
 
Abbreviation 
Definition 
AE 
Adverse event 
BPOM 
Indonesia Food and Drug Monitoring Agency 
CIOMS 
Council for International Organizations of Medical 
Sciences 
COVID-19 
Coronavirus Disease 19 
EU 
European Union 
EUA 
Emergency Use Authorization 
FDA 
Food and Drug Administration 
GPP 
Good Pharmacoepidemiology Practices 
IBM-SPSS 
Intelligence Based Manufacturing – Statistical Package 
of Social Science 
IRB 
Institutional Review Board 
ISRR 
Immunization Stress Related Response 
IQR 
Interquartiles Ranges 
modRNA 
Modified Ribonucleocid Acid 
MoH 
Ministry of Health 
mRNA 
Messenger Ribonucleic Acid 
NCAEFI 
National Committee of Adverse Event Following 
Immunization 
NI 
Non Interventional 
SAE 
Serious Adverse Events 
 
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SAP 
Statistical Analysis Plan 
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
WHO 
World Health Organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3. RESPONSIBLE PARTIES 
 
 
Principal Investigator(s) of the Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PPD 
NC AEFI (National 
Committee of AE 
Following 
Immunizattion) 
Pfizer 
PPD 
Dr. PPD 
PPD MSc-PH 
PPD 
Dr. PPD 
 
Pfizer 
Dr. PPD 
 
PPD 
 
Dr. PPD 
Address 
Affiliation 
Job Title 
Pfizer 
PPD 
PPD 
PPD 
PPD 
Name, degree(s) 

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4. ABSTRACT 
None 
5. AMENDMENTS AND UPDATES 
 
Amendment 
number 
Date 
Protocol 
section(s) 
changed 
Summary of amendment(s) 
Reason 
1 
administrative 
26 Apr 
2023 
Section 6 
MILESTONE 
S 
Modified Milestone 
NA 
Section 9 
RESEARCH 
METHODS 
Deletion of text of SAP: Detailed 
methodology for summary and 
statistical analyses of data collected 
in this study will be documented in a 
statistical analysis plan (SAP),etc 
Align with study team’s 
decision. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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6. MILESTONES 
 
Milestone 
Planned date 
Start of data collection 
16 March 2023 
End of data collection 
28 March 2023 
Final study report 
19 June 2023 
7. RATIONALE AND BACKGROUND 
 
BPOM (Indonesia National Regulatory Authority) has issued an Emergency Use Authorization (EUA) 
to permit the emergency use of Comirnaty 30 mg/dose for primary and 15 mg/dose for booster 
concentrate for dispersion for injection. Comirnaty is indicated for active immunization to prevent 
COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older in Indonesia. For 
detailed information please refer to the BPOM (Indonesia National Regulatory Authority) approved 
Fact Sheet For Health Care Providers EUA Of Comirnaty. 
 
The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 6 
months of age and older in 3 clinical studies conducted in the United States(US), Europe, Turkey, 
South Africa, and South America. Study BNT162-01 (Study 1) was a Phase 1/2, second-part, dose- 
escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is 
a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, 
dosefinding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled 
approximately 46,000 participants, 12 years of age or older. Of these, approximately 43,448 
participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 21,728 placebo] in 
Phase 2/3 are 16 years of age or older (including 138 and 145 participants 16 and 17 years of age in 
the vaccine and placebo groups, respectively) and 2,260 participants are 12 through 15 years of age 
(1,131 and 1,129 in the vaccine and placebo groups, respectively). Study C4591007 (Study 3) is a 
Phase 1/2/3 multicenter, randomized, dose-finding, open-label (Phase 1) and multinational, saline 
placebo-controlled, observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 
4,695 participants 5 through 11 years of age, of whom 3,109 participants received Pfizer-BioNTech 
COVID-19 Vaccine (10 mcg modRNA) and 1,538 participants received placebo in Phase 2/3. Study 
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3 also enrolled 1,776 participants 6 through 23 months of age, of whom 1,178 participants were in the 
Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA) group and 598 participants in the placebo 
group; and also enrolled 2,750 participants 2 through 4 years of age, of whom 1,835 participants were 
in the Pfizer-BioNTech COVID-19 Vaccine group and 915 participants in the placebo group in Phase 
2/3. Results from these clinical studies have been published in peer-reviewed journals. 
 
BPOM (Indonesia National Regulatory Authority) has requested to conduct an analysis of AEs 
reported in the Indonesia NC AEFI database following administration of BNT162b2 mRNA vaccine. 
 
8. RESEARCH QUESTION AND OBJECTIVES 
The objective of the study is to characterize descriptively the BNT162b2 vaccination safety experience 
among the Indonesian population, by analyzing structured data within Indonesia Vaccine Safety 
Website (Ministry of Health) as requested by BPOM (Indonesia National Regulatory Authority). 
 
9. RESEARCH METHODS 
9.1. Study design 
This is a descriptive study for secondary data collection and analysis of structured data regarding AEs 
reported in Indonesia Vaccine Safety Website, following administration of primary and booster dose 
BNT162b2 mRNA vaccine. This study will not provide or make recommendations on any vaccine 
use. 
A. The AEs reported in Indonesia Vaccine Safety Database, following administration of 
BNT162b2 mRNA vaccine, are expected to be structured and anonymized/ coded. Individual 
vaccine recipient identification information will not be collected in this study. The following 
data elements will be collected from the IndonesiaVaccine Safety Website for further 
analysis. Primary outcome measure : 
A1. SAE (Serious Adverse Event) : SAE after primary dose and/or booster dose 
A2. Total AE reported after primary dose and/or booster dose 
B. Secondary outcome measure : 
B1. SAE onset : ≤30 mins or > 30 mins 
B2. Causality of SAE : coincidence, ISRR (Immunization Stress Related Response), vaccine 
reaction, unclassifiable, or indeterminate 
 
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B3. Type of AE : 
B3.1. Serious and Non-serious 
B3.2. Solicited and unsolicited 
B4. Solicited AEs: 
B4.1.. Local reactions : pain, swelling, redness, thickness. 
B4.2. Systemic reactions: fever, myalgia, malaise 
B5. Unsolicited AEs: 
B5.1. Local reactions: abscess, bleeding, etc. 
B5.2. Systemic reactions: headache, nausea, arthralgia, etc. 
 
Since the study doesn’t involve primary data collection from any participants, there will be no 
requirement of individual consent/ assent. 
9.2. Setting 
The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as 
requested by BPOM (Indonesia National Regulatory Authority). After the study protocol is approved 
by BPOM (Indonesia National Regulatory Authority), structured data will be obtained retrospectively 
for all AEs reported following administration of the BNT162b2 mRNA vaccine, starting from the time 
of vaccine availablein Indonesia. Structured anonymized data for events which includes the following 
information will be collected and used for analysis: 
A. Primary outcome measure : 
A1. SAE (Serious Adverse Event) : SAE after primary dose and/or booster dose 
A2. Total AE reported after primary dose and/or booster dose 
B. Secondary outcome measure : 
B1. SAE onset : ≤30 mins or > 30 mins 
B2. Causality of SAE : coincidence, ISRR (Immunization Stress Related Response), vaccine 
reaction, unclassifiable, or indeterminate 
B3. Type of AE : 
B3.1. Serious and Non-serious 
B3.2. Solicited and unsolicited 
B4. Solicited AEs: 
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B4.1.. Local reactions : pain, swelling, redness, thickness. 
B4.2. Systemic reactions: fever, myalgia, malaise 
B5. Unsolicited AEs: 
B5.1. Local reactions: abscess, bleeding, etc. 
B5.2. Systemic reactions: headache, nausea, arthralgia, etc. 
Events for which either of the above is missing will not be recorded for analysis. 
9.2.1. Inclusion criteria 
This study will include adverse events reported in Indonesia NC AEFI database for individuals 12 
years of age and older 
9.2.2. Exclusion criteria 
The incomplete data in the database will be excluded 
9.3. Variables 
 
Variable 
Role 
Data source(s) 
Operational definition 
The type of 
vaccination with 
BNT162b2 mRNA 
vaccine following 
which SAE was 
reported 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
reported after primary 
series or booster 
vaccination 
Onset of SAE 
Baseline characteristic 
Indonesia Vaccine 
Safety Website 
Whether the serious 
AE onset ≤ 30 mins or 
> 30 mins 
Causality 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the SAE was 
caused by the vaccine. 
Causality of the AE 
with BNT162b2 – 
classified as WHO 
criteria as 
coincidence, ISRR, 
vaccine reaction, 
unclassifiable, or 
indeterminate) 
Type of AE 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
Serious and Non- 
serious or solicited 
and unsolicited 
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Type of solicited 
reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
local or systemic 
Type of Solicited 
Local reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
pain, swelling, redness 
or thickness 
Type of Solicited 
Systemic reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
fever, myalgia, 
malaise 
Type of unsolicited 
reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
local or systemic and 
the term reported 
Type of unsolicited 
local reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
abscess, bleeding, 
etc. 
Type of unsolicited 
systemic reaction 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
headache, nausea, 
athralgia, fatigue, etc 
Seriousness 
Baseline 
characteristics 
Indonesia Vaccine 
Safety Website 
Whether the AE was 
serious according to 
Indonesia MoH decree 
(require 
hospitalization, life- 
threatening, cause 
persistent or 
significant disability/ 
incapacity, or 
suspected to cause 
death) or non-serious 
9.4. Data sources 
In Indonesia Vaccine Safety Website for AEs reported following administration of BNT162b2 mRNA 
vaccine 
9.5. Study size 
This is a descriptive study without a statistical hypothesis and hence sample size calculation is not 
applicable. In this study all the AEs reported following administration of BNT162b2 mRNA vaccine 
 
 
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will be collected retrospectively from the onset of this vaccine administration in Indonesia till the time 
of approval of this study. 
9.6. Data management 
Data will be obtained from the Indonesia Vaccine Safety Website for AEs reported following 
administration of BNT162b2 mRNA vaccine as per the variables listed in section 9.3. A data 
management plan will be created before data collection begins and will describe all functions, 
processes, and specifications for data collection and analysis. 
9.7. Data analysis 
Descriptive Summary statistics will be presented to describe characteristics of events reports. 
Categorical covariates such as gender will be described by frequency distributions while continuous 
covariates such as age expressed will be summarized by in terms of their means and standard 
deviations or medians and interquartile ranges (IQR) as appropriate. 
In addition, incidence rates will be computed as the number of events divided by the total number of 
vaccines administered. 
All analyses will be done by Microsoft Excel 
9.8. Quality control 
Not applicable 
9.9. Limitations of the research methods 
This is a retrospective, observational study for secondary data collection and analysis of structured 
data regarding AEs reported in Indonesia NC AEFI database, following administration of BNT162b2 
mRNA vaccine. The data availability will be contingent on the data provision by Indonesia NC AEFI 
post study approval by BPOM (Indonesia National Regulatory Authority). Since the data will originate 
and be owned by the Indonesia NC AEFI database, data validation and external quality control 
measures will not be applicable as a part of this study. 
9.10. Other aspects 
Not applicable 
 
 
 
 
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10. PROTECTION OF HUMAN SUBJECTS 
10.1. Patient information 
This study involves data that exist in anonymized structured format and contain no patient personal 
information. 
10.2. Patient consent 
As this study involves anonymized structured data, which according to applicable legal requirements 
do not contain data subject to privacy laws, obtaining informed consent from patients by Pfizer is not 
required. 
10.3. Patient withdrawal 
Not applicable 
10.4. Institutional review board (IRB)/Independent ethics committee (IEC) 
There must be prospective approval of the study protocol, protocol amendments, and other relevant 
documents (e.g., informed consent forms if applicable) from the relevant IRBs/IECs. All 
correspondence with the IRB/IEC must be retained. Copies of IRB/IEC approvals must be 
forwarded to Pfizer. 
10.5. Ethical conduct of the study 
The study will be conducted in accordance with legal and regulatory requirements, as well as with 
scientific purpose, value and rigor and follow generally accepted research practices described in 
 
• Guidelines for Good Pharmacoepidemiology Practices (GPP). Public Policy 
Committee, International Society of Pharmacoepidemiology. Pharmacoepidemiology 
and Drug Safety 
2015; 25:2-10. https://onlinelibrary.wiley.com/doi/full/10.1002/pds.3891 
• Good Practices for Outcomes Research issued by the International Society for 
Pharmacoeconomics and Outcomes Research (ISPOR). 
http://www.ispor.org/workpaper/practices_index.asp 
• Good practices for real-world data studies of treatment and/or comparative 
effectiveness: 
Recommendations from the joint ISPOR-ISPE Special Task Force on real-world 
evidence in 
 
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health care decision making. 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5639372/ 
• International Ethical Guidelines for Epidemiological Studies issued by the Council for 
International Organizations of Medical Sciences (CIOMS). 
https://cioms.ch/shop/product/international-ethical-guidelines-for-epidemiological- 
studies/ 
• European Medicines Agency (EMA) European Network of Centres for 
Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological 
Standards in Pharmacoepidemiology. 
http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml 
• Food and Drug Administration (FDA) Guidance for Industry: Good 
Pharmacovigilance 
Practices and Pharmacoepidemiologic Assessment. 
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/gui 
dances/ 
ucm071696.pdf 
• FDA Guidance for Industry and FDA Staff: Best Practices for Conducting and 
Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data. 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/G 
uidance 
s/UCM243537.pdf 
• FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical 
Product Development to Support Labeling Claims. 
http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf 
 
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS 
This study involves data that exist as structured data by the time of study start. In these data sources, 
individual patient data are not retrieved or validated, and it is not possible to link (ie, identify a 
potential association between) a particular product and medical event for any individual. Thus, the 
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minimum criteria for reporting an AE (ie, identifiable patient, identifiable reporter, a suspect product, 
and event) cannot be met. 
 
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
In the event of any prohibition or restriction imposed (eg, 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. 
 
 
 
 
 
 
13. REFERENCES 
. 
1. US FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers): 
Emergency use authorization (EUA) of the Pfizer-Biontech COVID-19 vaccine to prevent 
coronavirus Disease 2019 (COVID-19); June 2022. 
https://www.fda.gov/media/159312/download accessed on 5 August 2022 
2. BPOM. Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of 
Comirnaty; July 2022. 
3. Thomas SJ et al.; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 
mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021 Nov 4;385(19):1761-1773. 
doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15. 
4. Thomas S.J., et al. (2021). "Safety and Efficacy of the BNT162b2 mRNACovid-19 Vaccine 
through 6 Months." N Engl J Med. 385(19):1761-1773. 2. Frenck, R. W., Jr., et al. (2021). 
"Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents." 
N Engl J Med. 385(3): 239-250. 3. Walter, E. B., et al. (2021). (2022) "Evaluation of the 
BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age." N Engl J Med. 386(1):35- 
46. 
5. Frenck RW Jr et al.; C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy 
of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239- 
250. doi: 10.1056/NEJMoa2107456. Epub 2021 May 27. 
 
 
 
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6. Polack FP et al.; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 
mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 
10.1056/NEJMoa2034577. Epub 2020 Dec 10. 
7. Mulligan MJ et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 
2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. Epub 2020 Aug 12. Erratum 
in: Nature. 2021 Feb;590(7844):E26. 
 
14. LIST OF TABLES 
None 
15. LIST OF FIGURES 
None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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