Secondary Databased Post-marketing Surveillance Study of BNT162b2

July 8, 2026 updated by: Pfizer
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence.

Primary objective:

  • To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea
  • To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design

Secondary objective:

- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit [ICU] admission, and COVID-19 death).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14302529

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals who were vaccinated with at least one dose of Pfizer COVID-19 vaccine according to locally approved label in Republic of Korea from 27 February 2021 through 31 December 2023.

Description

  1. Primary Objectives 1-1. Measure of Occurrence Inclusion Criteria For the measure of occurrence, analytical populations will include following individuals,

    • Who meet the predefined criteria for each study population.
    • With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period.

    Exclusion Criteria For the measure of occurrence, analytical populations will exclude following individuals,

    • With diagnosis of AESI during the AESI-specific clean window; or
    • With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose.

    1-2. Measure of Association Inclusion Criteria For the measure of association, analytical populations will include following individuals,

    • Who meet the predefined criteria for each study population.
    • With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and
    • Who had incident AESI during the observation period. Exclusion Criteria For the measure of association, analytical populations will exclude following individuals,
    • Who do not have both risk and control window time. If an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or
    • With a diagnosis of AESI during the AESI-specific clean window.

  2. Secondary Objective Inclusion Criteria For the secondary objective, the study populations will include following individuals,

    • Who meet the predefined criteria for each study population. Exclusion Criteria
    • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All primary series recipients using monovalent vaccine
All individuals who received first dose with monovalent vaccine as primary series (6 months or older).
Biological: Tozinameran (BNT162b2)

  1. 12 years or older

    • Primary series: 2 doses, 30 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot

  2. 5 to 11 years of age

    • Primary series: 2 doses, 10 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot

  3. 6 months to 4 years of age

    • Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
First booster recipients with monovalent vaccine
All individuals who received first booster recipients with monovalent vaccine (5 years of age or older).
Biological: Tozinameran (BNT162b2)

  1. 12 years or older

    • Primary series: 2 doses, 30 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot

  2. 5 to 11 years of age

    • Primary series: 2 doses, 10 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot

  3. 6 months to 4 years of age

    • Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
Second booster recipients with monovalent vaccine
All individuals who received second booster recipients with monovalent vaccine (5 years of age or older).
Biological: Tozinameran (BNT162b2)

  1. 12 years or older

    • Primary series: 2 doses, 30 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot

  2. 5 to 11 years of age

    • Primary series: 2 doses, 10 μg each, administered 21 days apart
    • Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot

  3. 6 months to 4 years of age

    • Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
All booster recipients using bivalent vaccine
All individuals who received booster recipients using bivalent vaccine (12 years of age or older).
Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)

1. 12 years or older

- Single booster dose, 15/15 μg, administered after ≥3 months after primary series

Biological: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)

1. 12 years or older

- Single booster dose, 15/15 μg administered after ≥3 months after primary series
Single-dose primary series recipients with bivalent vaccine
All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).
Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)

1. 12 years or older

- Single booster dose, 15/15 μg, administered after ≥3 months after primary series

Biological: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)

1. 12 years or older

- Single booster dose, 15/15 μg administered after ≥3 months after primary series
Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine
All individuals who received primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine (12 years of age or older).
Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)

1. 12 years or older

- Single booster dose, 15/15 μg, administered after ≥3 months after primary series

Biological: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)

1. 12 years or older

- Single booster dose, 15/15 μg administered after ≥3 months after primary series

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence
Time Frame: Up to 270 days after vaccination
Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Up to 270 days after vaccination
Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence
Time Frame: Up to 270 days after vaccination
Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed.
Up to 270 days after vaccination
Incidence of Adverse Events of Special Interest (AESI) - Measure of Association
Time Frame: Up to 270 days after vaccination
Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.
Up to 270 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Severe COVID-19 Outcomes
Time Frame: Up to 150 days after vaccination
The frequency of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Up to 150 days after vaccination
Incidence of Severe COVID-19 Outcomes
Time Frame: Up to 150 days after vaccination
The incidence of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Up to 150 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4591056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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