Analisi etica in un processo di HTA del vaccino anti-rotavirus

[Autom. eng. transl.] Due to the epidemiological dimension, Rotavirus gastroenteritis has a strong impact on the health of the child community and an important economic burden for public health. For these reasons, the development of an anti-Rotavirus vaccine has been considered a priority of the scientific community since as early as the 1970s. The first oral anti-Rotavirus vaccine was Rotashield® (Wyeth-Lederle Vaccines), authorized in the United States in 1998 and withdrawn a few months later following the confirmation of the important risk of intestinal intussusception (11-21 for 100,000 vaccinated). In 2006, two new-generation and orally administered anti-Rotavirus vaccines were approved by EMA (European Medicine Agency): Rotarix® (GlaxoSmithKline Biologicals) and RotaTeq® (Sanofi Pasteur MSD). The Rotarix® is, in particular, the subject of this ethical evaluation in a process of Health Technology Assessment (HTA).