Korea Comirnaty Post-marketing Surveillance
A Prospective, Single-arm, Open-label, Non-interventional, Multicenter to Assess the Safety of BNT162b2 in Domestic Post-marketing Surveillance
2 other identifiers
observational
12,000
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2027
April 23, 2026
April 1, 2026
4.9 years
August 27, 2021
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
28 days after administration of BNT162b2 products
Secondary Outcomes (7)
Number of subjects with Adverse Events (AEs)
28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Events
28 days after administration of BNT162b2 products
Number of subjects with Expected Adverse Events
28 days after administration of BNT162b2 products
Number of subjects with Adverse Drug Reactions
28 days after administration of BNT162b2 products
Number of subjects with Serious Adverse Drug Reactions
28 days after administration of BNT162b2 products
- +2 more secondary outcomes
Study Arms (4)
Tozinameran (BNT162b2)
Subjects aged 6 months and older who are scheduled for Tozinameran vaccination
Riltozinameran (BNT162b2 OMI BA.1)
Subject aged 12 years and older who are scheduled for Riltozinameran vaccination
Famtozinameran (BNT162b2 OMI BA.4-5)
Subject aged 5 years and older who are scheduled for Famtozinameran vaccination
Raxtozinameran (BNT162b2 OMI XBB.1.5)
Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination
Interventions
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
the subjects who received the BNT162b2 under an approved label for use in Korea in contracted study sites.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 2, 2021
Study Start
March 18, 2022
Primary Completion (Estimated)
January 24, 2027
Study Completion (Estimated)
January 24, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.