COVID-19NCT05032976
Korea Comirnaty Post-marketing Surveillance
An observational study of COVID-19 and Vaccines, run by Pfizer at 1 site in South Korea.
Trial summary
This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS). Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- COVID-19, Vaccines, Adverse Effects
- What is being tested?
- Tozinameran 12 Years of age and older, Tozinameran 5 to 11 Years of age and Tozinameran 6 months to 4 years of age
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2022to 24 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: the subjects who received the BNT162b2 under an approved label for use in Korea in contracted study sites.
- Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Korean subjects who are eligible for administration of BNT162b2 products (Including bivalent COVID-19 Vaccines for omicron) according to the locally approved and authorized label (indication, age criteria etc.)
- Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study - Data privacy statement signed by the subjects and parents or legal representative for subjects aged under 19
- Exclusion criteria Subjects meeting any of the following criteria will be excluded in the study
- Subjects who involved in the contraindications of use indicated in the locally approved and authorized label
- Subjects with a history of hypersensitivity to any ingredients of this product or this product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multicenter to Assess the Safety of BNT162b2 in Domestic Post-marketing Surveillance
This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).
Read the detailed description
This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. BNT162b2 products will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and patient (subject) report outcome (PRO), and record the information on each subject's case report form (CRF).
Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study. Investigators at the institution that sign the agreement should prepare the CRFs from all the subjects who this vaccine was administered to after the start date of the study.
Each investigator will sequentially enroll all subjects to whom BNT162b2 products is prescribed for the first time according to the local product document and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.
An electronic diary will be used in this study to collect adverse events that occur after injection. Follow-up exams will be carried out from after the first injection to before the second injection, and from after the second injection to 28 days after the second injection. Those who received booster doses will be followed up for the 28 days from the date of the booster dose. For the follow-up adverse event CRF, either an application using the mobile phones of subjects or entry on a paper questionnaire may be selected. The CRF will be filled out every day after the first and second injections. If an application is used, it is automatically sent as an eCRF. If a paper questionnaire is used, the questionnaire filled out after the first injection is collected at the time of the visit for the second injection, and the questionnaires filled out after the second injection and booster dose are collected 28 days after the second injection and 28 days after the booster dose respectively by mail.
To promote the collection of adverse events after injection, a reminder may be given by phone about entering the information and the collection of the CRF to subjects who gave consent beforehand. If it is difficult to record CRF due to the subject, the occurrence of adverse events can be confirmed by phone.
Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during 28 days from the date of the first, second and booster doses of BNT162b2.
- Conditions
- COVID-19, Vaccines, Adverse Effects, SARS-CoV-2, Safety
- Being tested
- Tozinameran 12 Years of age and older, Tozinameran 5 to 11 Years of age, Tozinameran 6 months to 4 years of age, Riltozinameran 12 Years of age and older, Famtozinameran 12 Years of age and older
- Keywords
- COVID-19, Vaccines,, Adverse Effects, SARS-CoV-2, Safety
- 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 12 Years of age and olderBiological
BNT162b2 (purple cap) is administered with dilution, while BNT162b2 (grey cap) is administered without dilution. Both formulations are administered by intramuscular injection (IM) of 0.3 mL. According to the approved and authorized label, the recommended dose of BNT162b2 is a series of two doses (1 day 1 dose, 0.3mL each) 21 days apart and administered IM.
Tozinameran 5 to 11 Years of ageBiological
BNT162b2 (orange cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, the recommended dose of BNT126b2 is a series of two dose (1day 1dose, 0.2mL) 21days apart and administered IM.
But, a third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised aged 5 to 11 years of age.
Tozinameran 6 months to 4 years of ageBiological
BNT162b2 (maroon cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, it is recommended that the recommended dose of BNT162b2 is administered by intramuscular injection (IM) twice (once a day, each 0.2mL) at least of 21 days apart, and Dose 3 at least 8 weeks later.
Children who will turn from 4 years to 5 years of age between their doses in the vaccination course should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the child's age at the start of the vaccination course.
The interchangeability of BNT162b2 with COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established.
BNT162b2 (6 months to 4 years of age) should be used only for infants and children 6 months to 4 years of age.
Riltozinameran 12 Years of age and olderBiological
The bivalent COVID-19 Vaccine for omicron (BA. 1) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 1) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 1) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran 12 Years of age and olderBiological
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran 5 to 11 Years of ageBiological
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age (orange cap) is administered after dilution by intramuscular injection (IM) of 0.2mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Raxtozinameran 12 years of age and olderBiological
BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, BNT162b2 OMI XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Raxtozinameran 6 months to 4 years of ageBiological
BNT162b2 OMI XBB.1.5 (maroon cap) is administered intramuscularly after dilution. For infants and children 6 months to 4 years of age without history of completion of a COVID-19, each 0.2 mL of dose is administered for a total of three vaccinations. The second dose is administered 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose. For infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS CoV-2 infection, a single dose of 0.2 mL is administered.
| Study group | Role | What they receive |
|---|---|---|
| Tozinameran (BNT162b2) | Subjects aged 6 months and older who are scheduled for Tozinameran vaccination Receives: Biological: Tozinameran 12 Years of age and older; Biological: Tozinameran 5 to 11 Years of age; Biological: Tozinameran 6 months to 4 years of age | |
| Riltozinameran (BNT162b2 OMI BA.1) | Subject aged 12 years and older who are scheduled for Riltozinameran vaccination Receives: Biological: Riltozinameran 12 Years of age and older | |
| Famtozinameran (BNT162b2 OMI BA.4-5) | Subject aged 5 years and older who are scheduled for Famtozinameran vaccination Receives: Biological: Famtozinameran 12 Years of age and older; Biological: Famtozinameran 5 to 11 Years of age | |
| Raxtozinameran (BNT162b2 OMI XBB.1.5) | Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination Receives: Biological: Raxtozinameran 12 years of age and older; Biological: Raxtozinameran 6 months to 4 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Solicited adverse events
Solicited adverse events within 1 week (Day 1-7) after each dose of BNT162b2 products, and a number of subjects with such events will be collected.
Measured: 1 week after administration of BNT162b2 products
Number of subjects with Unsolicited adverse events
Unsolicited adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Secondary outcomes (7)
Number of subjects with Adverse Events (AEs)
All adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Events
All Serious adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Expected Adverse Events
All expected adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Adverse Drug Reactions
All adverse Drug Reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Drug Reactions
All serious adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Expected Adverse Drug Reactions
All expected adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Number of subjects with Unexpected Adverse Drug Reactions
All unexpected adverse drug reactions within 28 days by its last dose, and a number of subjects with such events will be collected
Measured: 28 days after administration of BNT162b2 products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Mar 2022
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
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
- Prospective
- Enrolment
- 12,000 participants (estimated)
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
- NCT05032976
- Sponsor's protocol ID
- C4591025
- Other IDs
- NCT05032976
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Open-label, Non-interventional, Multicenter to Assess the Safety of BNT162b2 in Domestic Post-marketing Surveillance
- ClinicalTrials.gov ID
- NCT05032976
- Acronym / sponsor ID
- C4591025
- Conditions
- COVID-19, Vaccines, Adverse Effects, SARS-CoV-2, Safety
- Keywords
- COVID-19, Vaccines,, Adverse Effects, SARS-CoV-2, Safety
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 2 Sep 2021 (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 will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).
Detailed description
This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. BNT162b2 products will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and patient (subject) report outcome (PRO), and record the information on each subject's case report form (CRF).
Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study. Investigators at the institution that sign the agreement should prepare the CRFs from all the subjects who this vaccine was administered to after the start date of the study.
Each investigator will sequentially enroll all subjects to whom BNT162b2 products is prescribed for the first time according to the local product document and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.
An electronic diary will be used in this study to collect adverse events that occur after injection. Follow-up exams will be carried out from after the first injection to before the second injection, and from after the second injection to 28 days after the second injection. Those who received booster doses will be followed up for the 28 days from the date of the booster dose. For the follow-up adverse event CRF, either an application using the mobile phones of subjects or entry on a paper questionnaire may be selected. The CRF will be filled out every day after the first and second injections. If an application is used, it is automatically sent as an eCRF. If a paper questionnaire is used, the questionnaire filled out after the first injection is collected at the time of the visit for the second injection, and the questionnaires filled out after the second injection and booster dose are collected 28 days after the second injection and 28 days after the booster dose respectively by mail.
To promote the collection of adverse events after injection, a reminder may be given by phone about entering the information and the collection of the CRF to subjects who gave consent beforehand. If it is difficult to record CRF due to the subject, the occurrence of adverse events can be confirmed by phone.
Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during 28 days from the date of the first, second and booster doses of BNT162b2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tozinameran (BNT162b2) | – | Biological: Tozinameran 12 Years of age and older, Biological: Tozinameran 5 to 11 Years of age, Biological: Tozinameran 6 months to 4 years of ageSubjects aged 6 months and older who are scheduled for Tozinameran vaccination |
| Riltozinameran (BNT162b2 OMI BA.1) | – | Biological: Riltozinameran 12 Years of age and olderSubject aged 12 years and older who are scheduled for Riltozinameran vaccination |
| Famtozinameran (BNT162b2 OMI BA.4-5) | – | Biological: Famtozinameran 12 Years of age and older, Biological: Famtozinameran 5 to 11 Years of ageSubject aged 5 years and older who are scheduled for Famtozinameran vaccination |
| Raxtozinameran (BNT162b2 OMI XBB.1.5) | – | Biological: Raxtozinameran 12 years of age and older, Biological: Raxtozinameran 6 months to 4 years of ageSubject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the subjects who received the BNT162b2 under an approved label for use in Korea in contracted study sites.
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 12 Years of age and olderBNT162b2 (purple cap) is administered with dilution, while BNT162b2 (grey cap) is administered without dilution. Both formulations are administered by intramuscular injection (IM) of 0.3 mL. According to the approved and authorized label, the recommended dose of BNT162b2 is a series of two doses (1 day 1 dose, 0.3mL each) 21 days apart and administered IM. | Biological | Tozinameran (BNT162b2) |
| Tozinameran 5 to 11 Years of ageBNT162b2 (orange cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, the recommended dose of BNT126b2 is a series of two dose (1day 1dose, 0.2mL) 21days apart and administered IM. But, a third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised aged 5 to 11 years of age. | Biological | Tozinameran (BNT162b2) |
| Tozinameran 6 months to 4 years of ageBNT162b2 (maroon cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, it is recommended that the recommended dose of BNT162b2 is administered by intramuscular injection (IM) twice (once a day, each 0.2mL) at least of 21 days apart, and Dose 3 at least 8 weeks later. Children who will turn from 4 years to 5 years of age between their doses in the vaccination course should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the child's age at the start of the vaccination course. The interchangeability of BNT162b2 with COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established. BNT162b2 (6 months to 4 years of age) should be used only for infants and children 6 months to 4 years of age. | Biological | Tozinameran (BNT162b2) |
| Riltozinameran 12 Years of age and olderThe bivalent COVID-19 Vaccine for omicron (BA. 1) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 1) and the last prior dose of a COVID-19 vaccine. The bivalent COVID-19 Vaccine for omicron (BA. 1) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19. | Biological | Riltozinameran (BNT162b2 OMI BA.1) |
| Famtozinameran 12 Years of age and olderThe bivalent COVID-19 Vaccine for omicron (BA. 4-5) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) and the last prior dose of a COVID-19 vaccine. The bivalent COVID-19 Vaccine for omicron (BA. 4-5) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19. | Biological | Famtozinameran (BNT162b2 OMI BA.4-5) |
| Famtozinameran 5 to 11 Years of ageThe bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age (orange cap) is administered after dilution by intramuscular injection (IM) of 0.2mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age and the last prior dose of a COVID-19 vaccine. The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19. | Biological | Famtozinameran (BNT162b2 OMI BA.4-5) |
| Raxtozinameran 12 years of age and olderBNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status. For individuals who have previously been vaccinated with a COVID-19 vaccine, BNT162b2 OMI XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine. | Biological | Raxtozinameran (BNT162b2 OMI XBB.1.5) |
| Raxtozinameran 6 months to 4 years of ageBNT162b2 OMI XBB.1.5 (maroon cap) is administered intramuscularly after dilution. For infants and children 6 months to 4 years of age without history of completion of a COVID-19, each 0.2 mL of dose is administered for a total of three vaccinations. The second dose is administered 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose. For infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS CoV-2 infection, a single dose of 0.2 mL is administered. | Biological | Raxtozinameran (BNT162b2 OMI XBB.1.5) |
Primary outcome
Number of subjects with Solicited adverse events
Time frame: 1 week after administration of BNT162b2 products
Solicited adverse events within 1 week (Day 1-7) after each dose of BNT162b2 products, and a number of subjects with such events will be collected.
Number of subjects with Unsolicited adverse events
Time frame: 28 days after administration of BNT162b2 products
Unsolicited adverse events within 28 days by its last dose, and a number of subjects with such events will be collected
7 secondary outcomes
Number of subjects with Adverse Events (AEs)
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Events
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Expected Adverse Events
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Adverse Drug Reactions
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Drug Reactions
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Expected Adverse Drug Reactions
Time frame: 28 days after administration of BNT162b2 products
Number of subjects with Unexpected Adverse Drug Reactions
Time frame: 28 days after administration of BNT162b2 products
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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 Vaccines, 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of subjects with Solicited adverse events (time frame: 1 week after administration of BNT162b2 products). The study lists 2 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 23 Apr 2026.