This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence. Primary objective: * To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea * To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design Secondary objective: \- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit \[ICU\] admission, and COVID-19 death).
Study Type
OBSERVATIONAL
Enrollment
14,302,529
1. 12 years or older * Primary series: 2 doses, 30 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot 2. 5 to 11 years of age * Primary series: 2 doses, 10 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot 3. 6 months to 4 years of age * Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
1\. 12 years or older \- Single booster dose, 15/15 μg, administered after ≥3 months after primary series
Pfizer
Seoul, South Korea
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence
Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Time frame: Up to 270 days after vaccination
Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence
Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed.
Time frame: Up to 270 days after vaccination
Incidence of Adverse Events of Special Interest (AESI) - Measure of Association
Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.
Time frame: Up to 270 days after vaccination
Frequency of Severe COVID-19 Outcomes
The frequency of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Time frame: Up to 150 days after vaccination
Incidence of Severe COVID-19 Outcomes
The incidence of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Time frame: Up to 150 days after vaccination
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1\. 12 years or older \- Single booster dose, 15/15 μg administered after ≥3 months after primary series