A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People

Study Overview
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Brief Summary
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The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine. The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information. We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.

Official Title
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Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.

Conditions
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COVID-19

Intervention / Treatment
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* Biological: BNT162b2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COMIRNATY<br>COVID-19 mRNA vaccine | Biological: BNT162b2<br>* BNT162b2 half dose and full dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants reporting Serious Adverse Event (SAE) after primary vaccination as compared to booster dose |  | 1 year | 
| Total number of Adverse Events (AE) reported after both primary and booster dose |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of SAE less than or equal to 30 minutes | Number of participants reporting SAE less than or equal to 30 minutes | 1 year | 
| Onset of SAE more than 30 minutes | Number of participants reporting SAE onset more than 30 minutes | 1 year | 
| Participants categorized according to the World Health Organization (WHO) causality assessment of adverse events following immunization | WHO causality assessment of adverse event following immunization include (coincidence, Immunization Stress Related Response, vaccine reaction, unclassifiable, or indeterminate) | 1 year | 
| Number of participants reporting local solicited AEs | Local reaction include pain, swelling, redness or thickness | 1 year | 
| Number of participants reporting systemic solicited AEs | Systemic reaction include fever, myalgia, malaise | 1 year | 
| Number of participants reporting local unsolicited reactions | Local reactions includes abscess, bleeding, etc. | 1 year | 
| Number of participants reporting systemic unsolicited reaction | Systemic reaction include headache, nausea, arthralgia, etc. | 1 year | 
| Proportion of participants reporting serious AEs as compared to non serious AEs |  | 1 year | 
| Number of participants reporting solicited AE compared to unsolicited AE |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indonesia, Vaccine, BNT162b2