VAC4EU Background rates of AESI for COVID-19 vaccine

VAC4EU (Vaccine monitoring Collaboration for Europe) is the sustainability solution of the ADVANCE project which was funded by the Innovative Medicines Initiative from October 2013–March 2019. VAC4EU implements the ADVANCE vision, system and blueprint and enables robust and timely evidence-generation on the effects of vaccines in a collaborative manner in Europe for use by citizens, health care professionals, public health organisations and regulatory agencies. VAC4EU is a multi-stakeholder international association with a study network to run studies and an open community for scientific debate.

The VAC4EU and GVDN dashboard data are not comparable. The protocol methodologies, including study periods and data sources, are different. The VAC4EU data is based on European data sources with different coding systems that include but are not limited to ICD-10 codes compared with the GVDN background rates protocol, which is based on global data sources using ICD-10 only. Comparison of data obtained from implementation of the different VAC4EU and GVDN protocol methodologies will not provide reliable information and is not advised.

However, the VAC4EU and GVDN dashboard data are complementary. There is little overlap between the sites/countries that participated in the different studies, but where there is overlap, data sources and/or study periods are different. While the VAC4EU data currently provides background rates for more AESIs, the GVDN data provides more specific AESIs for thrombocytopenia (thrombocytopenia and idiopathic thrombocytopenia), venous thromboembolisms (pulmonary embolism and splanchnic vein thrombosis) and seizures (generalized seizures and febrile seizures).

The VAC4EU Dashboard Background rates of Adverse Events of Special Interest for COVID-19 vaccines is hosted on the Vaccine monitoring Collaboration for Europe (VAC4EU) website. The dashboard provides an interactive manner to query and explore the Background rates of adverse events of special interest for monitoring COVID-19 vaccines created as part of the EMA-funded ACCESS project.

VAC4EU dashboard data must be referenced as: 

Willame C, Dodd C, Gini R, Duran-Salinas C, Ehrenstein V, Thomsen RM, Kahlert J, Bartolini C, Paoletti O, Droz C, Moore N, Haug U, Schink T, Diez-Domingo J, Villalobos F, Perez-Gutthann S, Arana A, Giaquinto C, Barbieri E, Huerta C, Iglesias AM, Vergara C, Martin Perez M, Garcia Poza P, de Burgos A, Martinez-Gonzalez M, Bryant V, Trifiro G, Souverein P, Gardarsdottir H, Sisskonen SJ, Mahy P, Weibel D, Klungel O, Sturkenboom MCJM. Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccine | August 2021 | Source: