Secondary Databased Post-marketing Surveillance Study of BNT162b2

This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Biological: Tozinameran (BNT162b2); Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1); Biological: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)

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: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 12 years or olderPrimary series: 2 doses, 30 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot; 5 to 11 years of agePrimary series: 2 doses, 10 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot; 6 months to 4 years of agePrimary 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); 12 years or olderPrimary series: 2 doses, 30 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot; 5 to 11 years of agePrimary series: 2 doses, 10 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot; 6 months to 4 years of agePrimary 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); 12 years or olderPrimary series: 2 doses, 30 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot; 5 to 11 years of agePrimary series: 2 doses, 10 μg each, administered 21 days apartBooster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot; 6 months to 4 years of agePrimary 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

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence	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	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	Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.	Up to 270 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Severe COVID-19 Outcomes	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	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

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Safety; COVID-19 Vaccines
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID 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