This study is to identify any problems and questions with respect to the safety ofComirnaty Injection (Bretovameran) during the post-marketing period.
All assessments are performed as part of normal clinical practice or standard practice
guidelines for the subject population and healthcare provider specialty in the countries
where this non-interventional study is being conducted.
This study is conducted under normal clinical practice in accordance with regulatory
requirements. Therefore, the inclusion and exclusion criteria for study subjects are
related to indications and contraindications outlined in the local product document. This
study will not provide or make recommendations on any vaccine use. The vaccines are all
given as part of the standard of care. All enrolled subjects have to meet the general
prescription criteria for Comirnaty Injection (Bretovameran) according to the local
product document and have to be enrolled at the doctor's discretion.
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.
Comirnaty Injection (Bretovameran) will be administered according to the "Dosage and
Administration" of the authorized label. There is no visit or activity mandated by this
study. The investigator will collect data from the subject's medical records and diary
and record data on each subject's case report form (CRF).
Biological: Bretovameran
Comirnaty Injection (Bretovameran) 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.
Inclusion Criteria:
- Korean subjects who are eligible for administration of Comirnaty Injection according
to the locally authorized label
- Subjects with evidence of a personally signed and dated informed consent/assent
document indicating that the subject (or a legally acceptable representative) has
been informed of all pertinent aspects of the study
Exclusion Criteria:
- Subjects who involved in the contraindications of use indicated in the locally
authorized label
- Subjects with a history of hypersensitivity to any ingredients of this product or
this product
- Any subjects (or a legally acceptable representative) who does not agree that Pfizer
and companies working with Pfizer use his/her information
Pfizer Korea
Seoul, Korea, Republic of
Pfizer CT.gov Call Center, Study Director
Pfizer