COVID-19NCT06743334
Secondary Databased Post-marketing Surveillance Study of BNT162b2
An observational study of COVID-19 and SARS-CoV-2, run by Pfizer at 1 site in South Korea.
Trial summary
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Tozinameran (BNT162b2), Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) and Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)
- Type of treatment
- Vaccines
- How many people
- 14,302,529 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2025to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
Read the 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).
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Tozinameran (BNT162b2), Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1), Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)
- Keywords
- COVID-19 Vaccines, Safety, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tozinameran (BNT162b2)Biological
- 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
- 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
- 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)
Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)Biological
- 12 years or older
- Single booster dose, 15/15 μg, administered after ≥3 months after primary series
Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)Biological
- 12 years or older
- Single booster dose, 15/15 μg administered after ≥3 months after primary series
| Study group | Role | What they receive |
|---|---|---|
| All primary series recipients using monovalent vaccine | All individuals who received first dose with monovalent vaccine as primary series (6 months or older). Receives: 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). Receives: 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). Receives: Biological: Tozinameran (BNT162b2) | |
| All booster recipients using bivalent vaccine | All individuals who received booster recipients using bivalent vaccine (12 years of age or older). Receives: 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). Receives: 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). Receives: Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1); Biological: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence
Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Measured: 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.
Measured: 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.
Measured: Up to 270 days after vaccination
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 150 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start23 Apr 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14,302,529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743334
- Sponsor's protocol ID
- C4591056
- Status last verified
- May 2026
- First submitted
- 16 Dec 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Databased Post-marketing Surveillance Study of BNT162b2
- ClinicalTrials.gov ID
- NCT06743334
- Acronym / sponsor ID
- C4591056
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19 Vaccines, Safety, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,302,529 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| All primary series recipients using monovalent vaccine | – | Biological: Tozinameran (BNT162b2)All individuals who received first dose with monovalent vaccine as primary series (6 months or older). |
| First booster recipients with monovalent vaccine | – | Biological: Tozinameran (BNT162b2)All individuals who received first booster recipients with monovalent vaccine (5 years of age or older). |
| Second booster recipients with monovalent vaccine | – | Biological: Tozinameran (BNT162b2)All individuals who received second booster recipients with monovalent vaccine (5 years of age or older). |
| All booster recipients using bivalent vaccine | – | Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1), Biological: 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 | – | Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1), Biological: 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 | – | Biological: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1), Biological: 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). |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
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 |
|---|---|---|
| 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) | Biological | 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)1. 12 years or older - Single booster dose, 15/15 μg, administered after ≥3 months after primary series | Biological | 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)1. 12 years or older - Single booster dose, 15/15 μg administered after ≥3 months after primary series | Biological | 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 |
Primary outcome
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.
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.
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.
2 secondary outcomes
Frequency of Severe COVID-19 Outcomes
Time frame: Up to 150 days after vaccination
Incidence of Severe COVID-19 Outcomes
Time frame: Up to 150 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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 and SARS-CoV-2, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jul 2026. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence (time frame: Up to 270 days after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.