A Prospective, Single-arm, Open-label, Non-interventional, Multicenter to Assess the Safety of BNT162b2 in Domestic Post-marketing Surveillance

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.