Did active monitoring detect potentially elevated risk of health outcomes following BNT162b2 COVID-19 vaccination in the US pediatric population aged 5-17 years? medrxivpreprint COVID19 coronavirus covid vaccination vaccine health
By Neha MathurNov 2 2022Reviewed by Danielle Ellis, B.Sc. In a recent study posted to the bioRxiv* server, researchers used a nearly real-time monitoring framework for early detection of potential safety signals following the administration of the BNT162b2 vaccine in over three million United States children aged five to 17 years. They conducted this study under the US food and drug administration biologics effectiveness and safety initiative.
About the study In the present study, researchers used administrative claims data from three sources, viz., Optum, HealthCore, and CVS Health. These sources had BNT162b2 vaccination data stratified by age group through June 25, 2022, June 6, 2022, and June 31, 2022, from Optum, HealthCore, and CVS Health, respectively.
The researchers used claims-based algorithms to monitor 20 health outcomes identified through medical consultation and literature review. Notably, they also assessed the risk of myocarditis/pericarditis with varying risk windows and care settings. Finally, the team conducted monthly sequential testing using the Poisson maximized sequential probability ratio test. Next, they generated incidence rate ratios of these outcome rates compared to historical rates.
Younger males aged 12-29 years were at an increased risk of myocarditis/pericarditis following mRNA vaccines. Consistent with previous surveillance reports, the current study methods also could not detect a signal for myocarditis/pericarditis in young children aged five to 11 years.
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