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

An observational study of COVID-19, run by Pfizer at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: COVID-19
What is being tested?: BNT162b2
Type of treatment: Vaccines
How many people: 260 participants
Where: 1 siteIndonesia
Study dates: 15 Mar 2023to 3 Apr 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: people in Indonesia above 12 years of age who received vaccine and report an adverse event

Who may be able to join

This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Pfizer
Jakarta

Other trials in Indonesia

About this study

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

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.

Conditions: COVID-19
Being tested: BNT162b2
Keywords: Indonesia, Vaccine, BNT162b2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BNT162b2Biological
BNT162b2 half dose and full dose

Study groups in NCT05621239
Study group	Role	What they receive
COMIRNATY		COVID-19 mRNA vaccine Receives: Biological: BNT162b2

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
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.
Measured: 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)
Number of Participants With SAEs After Booster Dose
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.
Measured: 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)
Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose
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.
Measured: 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)
Number of Participants With Non SAEs After Booster Dose
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.
Measured: 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)

Secondary outcomes (6)

Number of SAEs Reported According to Time of Onset
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.
Measured: 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)
Number of Participants According to Causality of SAEs
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.
Measured: 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)
Number of Participants According to Type of AEs
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.
Measured: 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)
Number of AEs Reported According to Solicited and Unsolicited AEs
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.
Measured: 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)
Number and Type of Solicited AEs Reported
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).
Measured: 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)
Number and Type of Unsolicited AEs Reported
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).
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 20233 Apr 2023

First posted17 Nov 2022
Study start15 Mar 2023
Primary completion3 Apr 2023
Study completion3 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621239
Sponsor's protocol ID: C4591050
Other IDs: NCT05621239
Status last verified: May 2025
First submitted: 16 Nov 2022
Last updated: 20 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
ClinicalTrials.gov ID: NCT05621239
Acronym / sponsor ID: C4591050
Conditions: COVID-19
Keywords: Indonesia, Vaccine, BNT162b2
Study type: Observational
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Mar 2023 (actual)
Primary completion: 3 Apr 2023 (actual)
Study completion: 3 Apr 2023 (actual)
First posted: 17 Nov 2022 (actual)
Results: Posted 20 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
COMIRNATY	–	Biological: BNT162b2COVID-19 mRNA vaccine

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: people in Indonesia above 12 years of age who received vaccine and report an adverse event

Key inclusion criteria (1 listed)

This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2BNT162b2 half dose and full dose	Biological	COMIRNATY

Primary outcome

Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

6 secondary outcomes

Number of SAEs Reported According to Time of Onset
Time frame: 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)
Number of Participants According to Causality of SAEs
Time frame: 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)
Number of Participants According to Type of AEs
Time frame: 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)
Number of AEs Reported According to Solicited and Unsolicited AEs
Time frame: 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)
Number and Type of Solicited AEs Reported
Time frame: 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)
Number and Type of Unsolicited AEs Reported
Time frame: 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)

Results and safety

Results posted to the registry on 20 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BNT162b2 mRNA SARS-CoV-2 Vaccine	260	260

Primary outcome: Number of Participants With Serious Adverse Events (SAEs) After Primary Dose

Time frame: 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). Count of participants. Unit: Participants

Measure	BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose n = 150
Value	16

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants With SAEs After Booster Dose

Measure	BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose n = 110
Value	5

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose

Measure	BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose n = 150
Value	134

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants With Non SAEs After Booster Dose

Measure	BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose n = 110
Value	105

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

6 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose	16 of 150 (10.7%)	134 of 150 (89.3%)	3 of 150
BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose	5 of 110 (4.5%)	105 of 110 (95.5%)	2 of 110

Limitations and caveats (from the sponsor): A total of 72,394,389 participants (48,425,165 \[primary dose\] and 23,969,029 \[booster dose\] received BNT162b2 mRNA SARS-CoV-2 vaccine. Adverse events were reported in 260 participants following administration of the BNT162b2 mRNA vaccine, starting from the time of vaccine availability in Indonesia and data was obtained for these 260 participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Pfizer at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Adverse Events (SAEs) After Primary Dose (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.