The U.S. CDC Global COVID Vaccine Safety Project, in collaboration with the Global Vaccine Data Network (GVDN), has conducted a study to determine the background incidence rates of adverse events following COVID-19 vaccination. The study, which analyzed data from national and regional health care databases across 11 GVDN member sites, aimed to identify potential vaccine safety signals and support early safety investigations.
The analysis covered a span of five pre-pandemic years (2015–2019) and the initial year of the pandemic (2020), encompassing a population of 197 million people from Europe, Asia, North and South America, and Oceania. The conditions studied as adverse events of special interest (AESI) included myocarditis, pulmonary embolism, and Guillain-Barré syndrome.
Background rates are crucial for the comparison of medical conditions occurring before and after the introduction of a vaccine. They provide important data for investigating reports of medical events following vaccination and support vaccine safety monitoring efforts. The findings of the study were published in the journal Vaccine.
Dr. Steven Black, co-director of the GVDN, emphasized the significance of this collaborative global effort in ensuring vaccine safety and public confidence. Dr. Helen Petousis-Harris, another co-director of the GVDN, underscored the commitment to transparency, vaccine safety, informed risk assessments, and effective communication.
The GVDN has made all data related to this background rates study publicly available on their website. This accessibility aims to promote transparency and support greater confidence in vaccine safety. The data can be accessed through the data dashboard on the Global Vaccine Data Network’s website.
In conclusion, the Global Vaccine Data Network’s study on background incidence rates provides valuable insights into vaccine safety monitoring. The collaboration between international sites and the availability of data contributes to the ongoing efforts in ensuring the safety of vaccines and informing policy decisions.
– A. Phillips et al, Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis, Vaccine (2023). DOI: 10.1016/j.vaccine.2023.08.079
– University of Auckland