Reason for request

Inclusion

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

Insufficient

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Therapeutic use

-

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