Secondary Databased Post-marketing Surveillance Study of BNT162b2

Active, not recruiting

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

• Registration Number: NCT06743334
• Lead Sponsor: Pfizer

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Study Start: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-05-28
• Study Completion: 2025-05-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Second booster recipients with monovalent vaccine	Tozinameran (BNT162b2)	All individuals who received second booster recipients with monovalent vaccine (5 years of age or older).
All booster recipients using bivalent vaccine	Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)	All individuals who received booster recipients using bivalent vaccine (12 years of age or older).
All booster recipients using bivalent vaccine	Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)	All individuals who received booster recipients using bivalent vaccine (12 years of age or older).
Single-dose primary series recipients with bivalent vaccine	Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)	All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).
All primary series recipients using monovalent vaccine	Tozinameran (BNT162b2)	All individuals who received first dose with monovalent vaccine as primary series (6 months or older).
First booster recipients with monovalent vaccine	Tozinameran (BNT162b2)	All individuals who received first booster recipients with monovalent vaccine (5 years of age or older).
Single-dose primary series recipients with bivalent vaccine	Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)	All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).
Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine	Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)	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).
Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine	Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)	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).

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence	Up to 270 days after vaccination	Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence	Up to 270 days after vaccination	Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Association	Up to 270 days after vaccination	Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Frequency of Severe COVID-19 Outcomes	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.
Incidence of Severe COVID-19 Outcomes	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.

Trial Locations

Locations (1)

Pfizer; 🇰🇷 Soeul, Korea, Republic of