Expert opinion on rotavirus vaccination in infancy

Each year, around 75,000-150,000 children aged under five years of age are hospitalised in the EU/EEA due to rotavirus gastroenteritis. In addition, up to 4 times this number of children seek medical evaluation in emergency rooms or other out-patient facilities. Children seeking medical attention due to rotavirus disease have the potential to become sources of hospital-acquired infection, often affecting younger susceptible children hospitalised for other reasons.

Two rotavirus vaccines were authorised for prevention of rotavirus gastroenteritis in 2006. Vaccine effectiveness against hospitalisation ranges between 85 and 90%, and herd protection contributes to the overall impact of vaccination programmes.

As of May 2017, inclusion of rotavirus vaccines in the routine childhood immunisation programme has been initiated in 13 EU/EEA Member States, with one more EU/EEA Member State offering the vaccine in some regions. The remaining countries have not yet introduced the vaccine into their programmes for reasons related to cost effectiveness, insufficient expected epidemiological impact and competing health priorities. Other reasons identified included risk of emergence of serotypes not covered by the vaccine, improved clinical management preferred to vaccination, and concerns regarding safety, such as intussusception (a condition characterised by telescoping of the intestine onto itself).

Benefit-risk has been assessed by regulatory agencies worldwide and was found to be positive given the severity of disease and the availability of treatment of intussusception. In addition, a recent meta-analysis indicates that the risk of vaccine-related intussusception is reduced from approximately 1 in 20 000 to approximately 1 in 50 000 above the background incidence of 33 to 101 per 100,000 in unvaccinated, if the first dose is given before the age of 12 weeks.

Finally, the Expert Opinion suggests a series of monitoring activities to be considered in EU/EAA Member States and at EU level, including surveillance of severe rotavirus gastroenteritis leading to hospitalisation, rotavirus genotyping in a geographically representative sample and in breakthrough infections occurring in vaccinated infants, coverage and timing of vaccination and if needed follow up on routine adverse event reporting. Furthermore, to support cost effectiveness studies, the expert opinion encourages the sharing of health economic models among EU/EEA countries.