The human rotavirus vaccine (HRV) was first approved in 2004 for the prevention of rotavirus infection in young children.

As part of routine pharmacovigilance activities, we are monitoring the incidence of intussusception (IS) following vaccination with HRV, based on spontaneous reports.

Spontaneous reports collected since 2004 indicate a transient increased incidence of IS after vaccination with HRV, mostly within 7 days after the first dose and, to a lesser extent, after the second dose, which is in line with published literature.

Our analysis highlights the importance of early management of IS since this resulted in more favourable outcomes compared with delayed treatment.