The U.S. CDC (Centers for Disease Control and Prevention) Global COVID Vaccine Safety Project has generated background incidence rates on a range of conditions designated as AESI (Adverse Events of Special Interest) for COVID-19 vaccine safety monitoring. Conditions studied included myocarditis, pulmonary embolism, and Guillain-Barré syndrome.
Eleven GVDN member sites implemented standardized methods and analyzed data from national or regional health care databases covering 197 million people from Europe, Asia, North and South America, and Oceania. The study captured data across five pre-pandemic years and the initial year of the pandemic .
Medical conditions can occur following vaccination but are not necessarily related to the use of the vaccine. Background rates can be used to compare how often the sameoccur before and after a vaccine is introduced. This type of analysis can identify potential vaccine safety signals and support early safety investigations.
GVDN Co-Director Dr. Steven Black states,"With a collaborative global effort not yet seen in the vaccine safety space, the GVDN is pioneering these large-scale studies to assure the safety of vaccines and supportThe findings were recently published in the journal. Anastasia Phillips, lead author stated,"This study provides important data that can be used by many countries to investigate reports of medical events following vaccination and to support vaccine safety monitoring.
GVDN Co-Director Dr. Helen Petousis-Harris says,"The studies that we carry out will be made publicly available to support greater transparency,
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