At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
In Brief
An observational study evaluating BNT162b2 for COVID-19. Completed, enrolled 260 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
BNT162b2 half dose and full dose