RESUMEN
The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. 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.
RESUMEN
Public health organizations in different nations face similar needs for gathering and analyzing population health data to detect and manage infectious disease outbreaks, including outbreaks of the 2009 Novel H1N1 Influenza A virus or "swine flu." This paper presents our progress to date on the design and assessment of a multi-national public health informatics infrastructure for data collection and disease surveillance. This initial work, under the aegis of an open health tools collaborative, lays the foundation for best practices in patient care and public health preparedness in the national health IT sector. This multinational collaboration is the first to identify essential electronic health record (EHR) data sets as well as standard public health informatics indicators to electronically monitor a notifiable public health condition internationally.
