EC Approves Sanofi's Two-Dose Gardasil For Adolescents

Sanofi Pasteur MSD announced that it has received marketing authorization from the European Commission (EC) for its Human Papillomavirus (HPV) vaccine Gardasil, indicated for a two-dose schedule at zero and six months in pediatric patients aged from nine to 13 years old.

Study data showed that patients who received Gardasil experienced strong reduction in high grade pre-cancerous cervical lesions. National vaccination programs in Australia also led to the near disappearance of genital warts in patients involved in the program.

Dr. Stephen Lockhart, VP, development of Sanofi Pasteur MSD, said, “We are delighted to be able to offer this new, two-dose schedule. It is based on data showing that two doses elicited an immune response in adolescents comparable to that of 3 doses in young women to the four HPV types – 6, 11, 16 and 18 – included in Gardasil.” 

Human papillomavirus (HPV) types 16 and 18 were estimated to lead to around 48,000 new cancer cases every year, in a study of 26 European countries. Though HPV is not life-threatening, treatment is long, painful and often unsatisfactory.

Gardasil is a quadrivalent vaccine developed for the protection against cervical cancer and other genital diseases resulting from the HPV types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata). Published study data supported the vaccine’s positive impact on the prevention of genital disease caused by HPV types 6, 11, 16, and 18.

“These results are sustained three years after vaccination, which indicates that a two-dose zero to six month schedule of Gardasil, is able to induce high antibody levels for protection against HPV-diseases,” said VP Lockhart.

The approval of the new dose schedule for Gardasil came after the positive opinion from the European Medicines Agency (EMA) given last February.