- Date 01 April 2015
- Documents : 4
- Economic analysis
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ROTARIX and ROTATEQ, rotavirus vaccines
INFECTIOLOGY - NEW MEDICINAL PRODUCT
Opinions on drugs -
Posted on
Apr 17 2015
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 |
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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Economic analysis
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