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When the FDA needed to monitor COVID-19 vaccine safety across millions of Americans, traditional surveillance methods weren't fast enough. The CBER BEST Initiative required a partner who could analyze massive insurance claims data in near real-time to detect rare adverse events. IQVIA Government Solutions' surveillance system continuously monitored 17 adverse events among 15 million vaccinated individuals, providing critical safety insights to inform regulatory decisions.
The team implemented Poisson Maximized Sequential Probability Ratio Testing to compare observed versus expected outcome rates, enabling early detection of safety signals invisible in pre-licensure trials. Within months of vaccine rollout, the system identified elevated myocarditis/pericarditis rates in young men following mRNA vaccination.
This finding, published in The Lancet, represented one of the largest observational vaccine studies conducted at the time. By processing over 27 million vaccine doses across multiple insurance databases, IQVIA helped CBER make evidence-based regulatory decisions while vaccines were being administered nationwide. The surveillance system's ability to stratify risk by age, sex, and vaccine type allowed for targeted safety communications and informed clinical guidance, demonstrating how real-world data can enhance public health decision-making during critical moments.
