Gardasil (human papillomavirus vaccine [types 6, 11, 16, 18])
Gardasil is approved for vaccination of women aged 9 – 26 to protect against human papillomavirus (HPV) type 6, 11, 16 and 18 related cervical dysplasia and external genital lesions (EGL).
Clinical phase II and III trials with duration of maximum 4 years have shown that the risk for developing dysplasia and high-grade invasive changes was decreased relatively with 40 - 70 %. 60 – 120 persons have to be vaccinated to prevent one case of cervical dysplasia, carcinoma in situ or EGL in a period of 2-4 years. The vaccine has preventing and not treating effect.
As the studies are phase II and III trials, there are still no data about the long-term efficiency or long-term adverse effects of Gardasil. Data for prevention of development of cervical cancer is preliminary on surrogate parameters. Studies with clinical significant endpoints need longer observation time and may be a cause for ethical considerations.
The price for 0,5 mL Gardasil is 1.155,65 kr. Thus the total cost for the 3-dose series is 3.466,95 kr. The reimbursement status of Gardasil has yet not been cleared. National Board of Health is currently conducting an MTV, and the results will form the basis of decision about weather the HPV-vaccine will be a part of the children’s vaccine programme.
Gardasil was marketed 23th October 2006.
Institute for Rational Pharmacotherapy, 14 November 2006