LYON, France, April 7, 2016 /PRNewswire/ --
The European Commission granted marketing authorization for a two-dose schedule in
9-14 year old girls and boys for GARDASIL(R)9, the 9-valent HPV vaccine
Sanofi Pasteur MSD announced today that the European Commission has approved a 2-dose schedule for adolescent girls and boys aged 9 to 14 for GARDASIL(R)9, its 9-valent Human Papillomavirus (HPV) vaccine, for use in the 31 countries regulated by the European Medicines Agency (EMA). This new schedule brings the label for GARDASIL(R)9 in line with recommendations in several European countries that opted for 2-dose schedules in routine vaccination of adolescents in this age group, thereby enabling GARDASIL(R)9 to be considered in national vaccination programmes.
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GARDASIL(R)9 has been licensed in Europe since June 2015 according to a 3-dose schedule for active immunisation of individuals from the age of 9 years against cervical, vulvar, vaginal and anal cancers causally related to vaccine HPV types, and genital warts causally related to vaccine HPV types. It has been available in the United States since early 2015, with 7 million doses now distributed.
GARDASIL(R)9 is the only HPV vaccine to protect from diseases caused by nine HPV types. In Europe these nine types are responsible for approximately 90% of cervical cancers, 85-90 % of HPV-related vulvar cancers, 80-85% of HPV-related vaginal cancers, 90-95% of HPV-related anal cancer, and 90% of genital warts.
"The final approval of the 2-dose schedule for Gardasil 9 by the EU Commission is great news to improve HPV vaccination programmes across Europe for the benefit of all adolescent girls and boys, said David Khougazian, Chief Executive Officer at Sanofi Pasteur MSD. "We stand ready to engage with National and local Health Authorities to make Gardasil 9 immediately available in order to set the state-of-the-art HPV immunization programmes in Europe", he concluded.
Human papillomavirus-related cancers are preventable cancers against which we can readily make progress. SPMSD is working with national authorities to make GARDASIL(R)9 available throughout Europe, with the first launch based on this 2-dose schedule expected in Germany in the coming weeks. Until GARDASIL(R)9 is available, it is important to maintain effective HPV vaccination programmes with existing vaccines to ensure high vaccination coverage and protection of the populations against the cancers and diseases caused by HPV 16, 18, 6 and 11.
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Sanofi Pasteur MSD
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