Secondary Databased Post-marketing Surveillance Study of BNT162b2

NCT06743334 | Completed

• 1 other identifier: C4591056
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19 Vaccines; Safety; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Frequency of Severe COVID-19 Outcomes

  Up to 150 days after vaccination

• Incidence of Severe COVID-19 Outcomes

  Up to 150 days after vaccination

Study Arms (6)

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)

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)

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)

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

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

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

Interventions

Tozinameran (BNT162b2) BIOLOGICAL

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 primary series recipients using monovalent vaccine; First booster recipients with monovalent vaccine; Second booster recipients with monovalent vaccine

Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) BIOLOGICAL

1\. 12 years or older \- Single booster dose, 15/15 μg, administered after ≥3 months after primary series

All booster recipients using bivalent vaccine; Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine; Single-dose primary series recipients with bivalent vaccine

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

1\. 12 years or older \- Single booster dose, 15/15 μg administered after ≥3 months after primary series

All booster recipients using bivalent vaccine; Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine; Single-dose primary series recipients with bivalent vaccine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 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.
• None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; famtozinameran

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: April 23, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)