Two new rotavirus vaccines are expected to be introduced in the European Union 
(EU) in coming years. A human rotavirus vaccine has already been licensed in 
several countries worldwide, and a pentavalent bovine vaccine has been submitted 
for licensure in the United States and the EU. Few data exist on the burden of 
rotavirus disease and its associated costs within the EU. To estimate the burden 
of rotavirus disease in the EU, we adapted a model based on the approach 
developed by the Centers for Disease Control and Prevention to the European 
situation and applied it to recent population and mortality data from European 
countries. Country-specific estimates were added to obtain a global estimate of 
rotavirus episodes treated at home, clinic visits, hospitalization and death. We 
estimate that 3.6 million episodes of rotavirus disease occur annually among the 
23.6 million children younger than 5 years of age in the EU. Every year, 
rotavirus accounts for 231 deaths, >87,000 hospitalizations and almost 700,000 
outpatient visits. Rotavirus disease constitutes a large public health burden in 
the EU. Except for deaths, the burden of disease is not dissimilar to that in 
the developing world. Country-specific studies are required to more accurately 
understand the burden of disease caused by rotavirus. With the introduction of 
new rotavirus vaccines in sight, rotavirus gastroenteritis may be regarded as 
the single most frequent vaccine-preventable disease among children in the EU.