ROTARIX, rotavirus vaccines
                   			INFECTIOLOGY - NEW MEDICINAL PRODUCT
						
                   	
                    
                        Opinions on drugs - 
	
		Posted on 
	
		
			Jun 08 2015
		
		
	
	
						
                    
                Reason for request
										Inclusion
									
									
- 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 | - | 
Therapeutic use
| - | 
-
Economic analysis
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