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European Committee for Medicinal Products for Human Use approves update to Gardasil® SmPC to include long-term protection data

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Immunogenicity and effectiveness data from long-term follow-up of Gardasil® studies demonstrates sustained protection against HPV 6, 11, 16 and 18 disease

September 12, 2014

Sanofi Pasteur MSD announced today that the Summary of Product characteristics (SmPC) of Gardasil has been updated to include new data related to long-term protection. (1)
The duration of protection of Gardasil is being monitored through different long-term extension studies from clinical trials in a number of countries. The follow-up will continue to reach 10 years.(1) The current available data show sustained protection against clinical disease irrespective of age or sex.In the extension study for girls and boys aged 9 to 15 years at first vaccination, protection against vaccine-type HPV diseases is maintained at 6.5 years post-vaccination. The total extension period is planned for 10 years. (1)In addition, in the extension of a study in women vaccinated at 16-23 years of age, no cases of cervical pre-cancers due to vaccine-type HPV were detected up to approximately 8 years. In the same study, durable protection was statistically demonstrated to about 6 years. The follow-up in this population will continue to reach 14 years. (1)These studies also show that the immune response persists after a follow-up of 8 years for 9-15 year-old adolescents and 9 years for women 16-23 year-old. (1)

As written in the Committee for Medicinal Products for Human Use (CHMP) report, the administration of Gardasil to 9 to 15 years girls and boys was generally well tolerated through 8 years post–vaccination follow-up. (1)

Data from long-term follow-up studies also support the long term safety of Gardasil in the other populations studied. (1)

The CHMP report concluded that “immunogenicity and effectiveness data from the long-term follow-up of Gardasil studies demonstrate continued protection against HPV 6, 11, 16 and 18 disease.” (1)

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. (2)

About Gardasil long-term protection data

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

About HPV vaccination programmes

All European countries currently implement cervical cancer/HPV vaccination programmes for girls, many in a schools based setting. Austria’s HPV vaccination programme starting in September 2014 will vaccinate all boys and girls against HPV with Gardasil. For further details of European vaccination programmes visit ecdc website at http://www.ecdc.europa.eu/

About Gardasil®

Gardasil®, manufactured by Merck, is a quadrivalent vaccine for protection against cervical and anal cancers and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the anus (AIN2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata).(2)Launched in 2006, it is the most widely used HPV vaccine worldwide with approximately 152 million doses distributed to date.(3)

About Sanofi Pasteur MSD 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 development 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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