In November 2025, one of the FDA’s chief vaccine regulators, Vinay Prasad, reported in a memo that although the FDA “never publicly admitted it,” children in the United States died as a result of COVID-19 vaccination. Details of this conclusion depend on one element of the vaccine safety monitoring system, the Vaccine Adverse Event Reporting System (VAERS).
To facilitate understanding of how the U.S. monitors vaccine safety, Jeffrey S. Morris, PhD, authored the new APPC white paper, The Complementary Components of the U.S. Vaccine Safety Monitoring System, analyzing the multicomponent U.S. system, explaining strengths, limitations, and analytical considerations for each component and describing how it is intended to function as an integrated system.
Morris offers a series of suggested improvements. “Although the COVID-19 pandemic drew greater public attention to vaccine safety, and to parts of the monitoring system, there is still limited understanding of the system’s full architecture, how each component operates, and how they are intended to interact to form an integrated safety net,” Morris writes. With this white paper, “the aim is to improve public explanations of the system, spur discussion on how to enhance it, and help sustain a robust safety monitoring infrastructure that earns public confidence.”