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Clinical Trials in South Korea / NCT05032976
Active, not recruiting Observational

Korea Comirnaty Post-marketing Surveillance

NCT05032976 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pfizer
Phase
Observational
Started
2022-03-18
Last updated
2026-04-23

Condition(s) studied

COVID-19VaccinesAdverse EffectsSARS-CoV-2Safety

Investigational drug(s) / intervention(s)

Tozinameran 12 Years of age and olderTozinameran 5 to 11 Years of ageTozinameran 6 months to 4 years of ageRiltozinameran 12 Years of age and olderFamtozinameran 12 Years of age and olderFamtozinameran 5 to 11 Years of ageRaxtozinameran 12 years of age and olderRaxtozinameran 6 months to 4 years of age

Tozinameran 12 Years of age and older: 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 age: 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 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.

Riltozinameran 12 Years of age and older: 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 older: 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 age: 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 older: 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 age: 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 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).

Eligibility

Sex
ALL
Min age
6 Months
Max age
—
Healthy volunteers
No
1\. Inclusion criteria Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. 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.) 2. 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 2\. Exclusion criteria Subjects meeting any of the following criteria will be excluded in the study 1. Subjects who involved in the contraindications of use indicated in the locally approved and authorized label 2. Subjects with a history of hypersensitivity to any ingredients of this product or this product

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Pfizer Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05032976 on ClinicalTrials.gov ↗ ← All trials in South Korea