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Active Surveillance for COVID-19 Vaccine Safety Using Sequential Analysis in Korea: Population-Based Retrospective
Na-Young Jeong1, Haerin Cho2, Heehyun Won2
1Health Science Convergence Research Institute, College of Science & Industry Convergence, Ewha Womans University, Seoul, Republic of Korea.
JMIR Public Health and Surveillance
|April 23, 2026
Summary
Near real-time surveillance detected safety signals for myocarditis and anaphylaxis following COVID-19 vaccination. This approach can identify potential adverse events early for regulatory review.
Area of Science:
- Public Health
- Vaccine Safety
- Pharmacovigilance
Background:
- The introduction of new vaccines, including COVID-19 vaccines, necessitates robust near real-time active surveillance systems.
- Timely regulatory decision-making relies on efficient monitoring of vaccine safety.
- Assessing potential adverse events following immunization (AEFI) is crucial for public health.
Purpose of the Study:
- To evaluate the feasibility of using sequential monitoring for detecting potential adverse events following COVID-19 vaccination in Korea.
- To assess the timeliness of signal detection for specific adverse events compared to regulatory actions.
Main Methods:
- A population-based study utilizing linked COVID-19 registry and national health insurance claims data.
- Retrospective monthly sequential testing for prespecified outcomes (myocarditis, anaphylaxis, acute myocardial infarction) and a negative control (colonic diverticulitis).
- Poisson-based sequential probability ratio test applied to compare postvaccination incidence with background rates, accounting for multiple testing and data lags.
Main Results:
- Over 43 million monovalent and 6.3 million bivalent COVID-19 vaccine recipients were analyzed.
- Statistical safety signals for myocarditis were detected following mRNA and protein subunit vaccines.
- Signals for anaphylaxis were observed with mRNA and viral vector vaccines; no signals for acute myocardial infarction or colonic diverticulitis were found.
Conclusions:
- Near real-time sequential testing effectively identified safety signals for myocarditis and anaphylaxis post-COVID-19 vaccination.
- The detected signals were recognized by regulatory authorities, validating the approach for early detection of potential vaccine-related adverse events.
- This methodology shows promise for monitoring newly introduced vaccines and informing causality assessments promptly.
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