In November 2013, the French High Council of public health (HCSP) had recommended the introduction of infant immunisation against rotavirus infections under acceptable cost/efficacy ratio conditions, as well as pursuing the strengthened pharmacovigilance monitoring relating to the notification of Acute Intestinal Invaginations (AII), the risk of which was to be communicated to families.

The notification of serious adverse events, including potentially fatal ones, following infant immunisation against rotavirus infections, leads the HCSP to reconsider its position regarding this vaccine.

Due to the unfavourable outcomes of some reported cases of IIA (death, resections), probably related to late treatment, and unable to rule out a re-occurrence of such situations, the HCSP suspends the recommendation to vaccinate infants against rotavirus infections in the general population.

In addition, neither international literature covering industrialised countries, nor national epidemiological data have led to the identification of any comorbidity factors or environmental factors (living conditions, geographic area in the country) with the potential to define a population of infants for whom the benefit/risk balance might be more favourable. It is not therefore possible to propose a selective vaccination strategy targeted to certain infants.

Furthermore, the HCSP reminds that if this vaccine is given on an individual basis and within its marketing authorisation (MA), the physician must inform the vaccinated child's family of the risk of acute intestinal invagination and of the clinical manifestations requiring emergency medical attention.

Recommendation Europe France Rotavirus