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Merck and Sanofi Pasteur Gardasil approved in EU-PR Newswire Europe


Sunday, 6 Apr 2014 08:00pm EDT 

Sanofi SA:European Commission grants marketing authorization for quadrivalent Human Papillomavirus (HPV) vaccine Gardasil developed by Sanofi Pasteur and Merck & Co Inc joint venture Sanofi Pasteur MSD - PR Newswire Europe.Authorization is granted for 2-dose schedule at 0 and 6 months in children aged from 9 to 13 years.Approval of this new schedule for Gardasil follows positive opinion from European Medicines Agency (EMA) granted in February, based on Canadian study performed by Dobson et al.Study demonstrated that 2-dose 0, 6 month schedule in 9-13 year old girls elicited immune response comparable/non-inferior to that of 3 doses in 16-26 year old women, population where quadrivalent vaccine efficacy has been shown.Results were sustained at 36 months of follow-up. 

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