ROTARIX and ROTATEQ, rotavirus vaccines

Opinions on drugs - Posted on Apr 17 2015

Reason for request


Insufficient actual benefit in the prevention of gastroenteritis due to rotavirus infection


  • ROTARIX and ROTATEQ are live attenuated oral vaccines with Marketing Authorisation since 2006 in the prevention of acute gastroenteritis due to rotavirus infection (RV-AGE) in infants.
  • The efficacy of these vaccines is high, but the most recent safety data confirm an increased risk of acute intussusception (AI) estimated at about 6 additional cases per 100,000 vaccinated individuals.
  • In view of the risk of AI and given the epidemiology of RV-AGE in France, rotavirus vaccination is not expected to impact on public health if vaccine coverage is low.

Clinical Benefit


Le service médical rendu par ROTATEQ est insuffisant dans l’immunisation active des nourrissons âgés de 6 à 24 semaines pour la prévention des gastro-entérites dues à une infection à rotavirus, pour une prise en charge par la solidarité nationale.



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