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

Completed

Conditions: COVID-19

Interventions: Biological: BNT162b2

Registration Number: NCT05621239

Lead Sponsor: Pfizer

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 260

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COMIRNATY	BNT162b2	COVID-19 mRNA vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events (SAEs) After Primary Dose	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Number of Participants With SAEs After Booster Dose	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.
Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Number of Participants With Non SAEs After Booster Dose	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Number of SAEs Reported According to Time of Onset	Within 30min and>30min after vacc., secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days)included AEs reported following administration vacc. from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of SAEs reported according to time of onset less than equal to (\<=30) minutes (min) and more than (\>) 30 minutes after administration of BNT162b2 mRNA vaccine primary and booster dose are reported in this outcome measure.
Number of Participants According to Causality of SAEs	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The causality of SAEs were classified as coincidence: inconsistent causal association to immunization; vaccine reaction, indeterminate: when adequate information is available but it is not possible to assign it, unclassifiable.
Number of Participants According to Type of AEs	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	AEs can be categorised into SAEs and non-SAEs. SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs.
Number of AEs Reported According to Solicited and Unsolicited AEs	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry and unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form.
Number and Type of Solicited AEs Reported	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry. These were classified as local reactions (local pain, local swelling, local erythema) and systemic reactions (fever, nausea/vomitus, headache, malaise/fatigue, arthralgia/myalgia, chill and diarrhea).
Number and Type of Unsolicited AEs Reported	The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)	An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form. These were classified as local reactions (local sore, local itch and erythema) and systemic reactions (vertigo/dizziness, cough/rhinitis/sore throat, itchy, dyspnea/tachypnea, drowsiness, syncope/loss of consciousness, hypesthesia/paresthesia, chest pain/chest tightness, stomach ache/dyspepsia, seizure, paralysis/paresis, slurred speech, hyperhidrosis and insomnia).