Overview of U.S. COVID-19 vaccine safety surveillance systems

This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.PMID:38631952 | DOI:10.1016/j.vaccine.2024.02.065

Source: Vaccine - April 17, 2024 Category: Allergy & Immunology Authors: Julianne Gee Tom T Shimabukuro John R Su David Shay Margaret Ryan Sridhar V Basavaraju Karen R Broder Matthew Clark C Buddy Creech Francesca Cunningham Kristin Goddard Harrison Guy Kathryn M Edwards Richard Forshee Tanya Hamburger Anne M Hause Nicola P Kl Source Type: research