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Korea Comirnaty Post-marketing Surveillance

Active Not RecruitingN/A

Sponsor: Pfizer

Conditions: COVID-19, Vaccines, Adverse Effects, SARS-CoV-2, Safety

Interventions: 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

Countries: South Korea

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 overview

Sex: ALL

Age: 6 Months to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Seoul, South Korea