Update on Gardasil for Cervical Cancer-Sanofi

Sanofi Pasteur MSD announced that the Summary of Product characteristics (SmPC) of Gardasil vaccine for Cervical Cancer has been updated to include new data related to long-term protection. The result of follow-up studies of Gardasil have demonstrated sustained protection in different populations irrespective of age or sex both in terms of clinical disease and antibody levels.

For the following groups, no cases of HPV 6/11/16/18- related disease were seen in: -Women from 16-23 year : no CIN any grade cases up to 8 years (in this study, a durable protection was statistically demonstrated to approximately 6 years) -Women from 24-45 year : no CIN any grade and genital warts cases up to 6 years -Girls from 9-15 year : no CIN any grade and genital warts cases up to 6.9 years -Boys from 9-15 year : no external genital lesions up to 6.5 years -Men from 16-26 years : no external genital lesions up to 6 years.

This significant update comes in addition to the recent improvements of Gardasil product profile, with a new indication to prevent anal cancer and precancerous anal lesions as well as a schedule of 2 doses 6 months apart for the adolescents 9 to 13 years old. The follow-up will continue to reach 10 years.