Case Study: U.S. Food and Drug Administration (CBER BEST Initiative) achieves rapid detection and evaluation of myocarditis/pericarditis safety signals after COVID-19 vaccination with IQVIA

Surveillance system detected and evaluated a myocarditis/pericarditis safety signal with COVID-19 vaccines

U.S. Food and Drug Administration Company’s Center for Biologics Evaluation and Research (CBER) operates the BEST Initiative to monitor safety of CBER‑regulated biologics using real‑world administrative claims data. To detect rare adverse events following COVID‑19 vaccination in near real time, the U.S. Food and Drug Administration Company engaged data partners and advisors, including IQVIA (IQVIA Government Solutions), to provide federated claims data and scientific support for active surveillance.

IQVIA supplied administrative claims through a federated data network, applied sequential Poisson maximized sequential probability ratio testing for signal detection, and supported retrospective cohort analyses; this work identified a myocarditis/pericarditis signal 1–7 days after mRNA vaccination and underpinned a Lancet‑published study. IQVIA’s analysis found 411 myocarditis/pericarditis events among 15,148,369 people (16,912,716 BNT162b2 doses and 10,631,554 mRNA‑1273 doses), showed the events were rare but elevated versus pre‑COVID background—highest in men 18–25 after dose two—with no statistically significant difference between vaccines, enabling timely regulatory evaluation.