GARDASIL® 9: CHMP positive opinion granted for a 2-dose schedule, in line with most of current recommendations in European countries for HPV vaccination
CHMP evaluated positively a 2-dose schedule in 9-14 year old girls and boys
for GARDASIL®9, the 9-valent HPV vaccine
Lyon, France – February 26 2015 - Sanofi Pasteur MSD announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a two-dose schedule in adolescent girls and boys aged 9 to 14 year old for its Human Papillomavirus (HPV) vaccine GARDASIL® 9.
GARDASIL® 9 is indicated for active immunisation of individuals from the age of 9 years against the following: HPV cervical, vulvar, vaginal and anal cancers causally related to vaccine HPV types. and genital warts causally related to specific HPV types.
Gardasil 9 is anticipated to protect against the HPV types that cause 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.
"This is a significant step forward in preventing more cancers and diseases caused by HPV," said Dr Stephen Lockhart, Head of Development at Sanofi Pasteur MSD. "If approved by the European Commission, this variation will enable GARDASIL® 9 to be included in vaccination programmes with a two-dose schedule, in line with the two HPV vaccines currently available, providing protection against additional types that are not contained in currently marketed HPV vaccines", he concluded.
The European license application is supported by the results of a clinical trial performed in about 1,200 girls and boys aged 9 to 14 years old, compared to a group of 300 young women 16 to 26 years old, the age group in which the efficacy of GARDASIL® 9 was demonstrated. The study successfully showed the non-inferiority of the anti-HPV immune responses for all 9 types in girls and boys 9-14 years of age who received 2 doses either in a 0, 6 months schedule or a 0, 12 months schedule, compared to young women 16-26 years of age who received 3 doses in a 0, 2, 6 months schedule.
The CHMP’s positive opinion for the 2-dose schedule will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
GARDASIL® 9 was approved in June 2015 with a 3-dose schedule.
Human papillomavirus-related cancers are preventable cancers against which we can readily make progress at reduction. Until GARDASIL® 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.
About GARDASIL® 9
GARDASIL® 9, manufactured by Merck, is the first and only nonavalent HPV vaccine helping to protect females and males against genital diseases and cancers caused by 9 human papillomavirus types (6, 11, 16, 18, 31, 33, 45, 52, 58) causing approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide.
Seven HPV types also cause 85-90% of HPV-related vulvar cancers, 80-85% of HPV-related vaginal cancers, and 90-95% of HPV-related anal cancers. HPV types 6 and 11 cause approximately 90% of genital warts cases.
About Sanofi Pasteur MSD http://www.spmsd.com
Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck’s research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.
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