CHMP recommends 2-dose schedule Gardasil for Cervical Cancer - Sanofi Pasteur MSD
The quadrivalent HPV vaccine, Gardasil, from Sanofi Pasteur MSD, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of a two-dose schedule in 9 to and including 13 year old adolescent girls and boys to protect against Cervical Cancer.
The European licence application is supported by the results of a study performed in Canada which demonstrates that antibody levels 1 month after a 2 dose schedule (0,6 months) of Gardasil in 243 girls 9-13 years old are non-inferior to the ones observed 1 month after a 3-dose schedule (0, 2, 6 months) in 272 16-26 years old women, population in which efficacy has been demonstrated. Gardasil is currently licensed as a 3 dose vaccination schedule at 0, 2, 6 months in both girls and boys from the age of 9 years, for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and Cervical Cancer causally related to certain oncogenic Human Papillomavirus types and genital warts (condyloma acuminata) causally related to specific HPV types.
150 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.