The first vaccine capable of preventing cervical cancer and other diseases caused by the human papillomavirus was launched yesterday in the UK. Gardasil, which was developed by Sanofi Pasteur MSD and received its European license in September, has the potential to dramatically reduce the rate of this killer disease, being 100% effective against the strains of HPV that cause three quarters of all cases.
Speaking at a launch meeting in London yesterday, Richard Stubbins, Managing Director of Sanofi Pasteur MSD UK and Ireland, proudly told delegates: “Be in no doubt, Gardasil is a fantastic breakthrough. This, for me, is a historic moment. We have, for the first time, a vaccine against cancer.”
And Margaret Stanley, Professor of Epithelial Biology at the University of Cambridge, echoed his delight: “Today is red letter day for me, marking a new era in the fight against cancer.”
Cervical cancer is the second most common cancer in women under the age of 44, claiming two lives an hour in Europe, so the disease burden is huge, she explained. In clinical trials, Gardasil was shown to be 100% effective against the human papilloma virus types 6, 11, 16 and 18, which together are responsible for 75% of all cervical cancer, so its use will dramatically cut the disease’s prevalence and death rates.
According to Michael Watson, the company’s Executive Director of Clinical Development Europe, Gardasil will slash 75% of all cervical cancer cases, and will prevent a whopping 95% of vulval/vaginal cancers and 90% of genital warts, of which there are around 250,000 new cases every year.
And, as Margaret points out, although the primary aim and benefit of the vaccine is reducing the number of deaths from the disease, the economic impact of its use will be substantial, as the number of abnormal smears, incidence of genital warts and other HPV-related diseases, and the need for surgery should plummet, easing the burden on the National Health Service’s already stretched resources.
The immune response is optimal in puberty, but clinical trails also revealed excellent results for the older age group, so Gardasil is currently approved for use in children aged nine-15 and adult females aged 16 to 24. The NHS cost for one dose is £80.50, and a person needs three doses for protection, but if a school program for vaccinating nine-12 year olds gets the go-ahead, a discount will be given for bulk orders from the government, Stubbins said.
Gardasil’s future will be somewhat shaped by recommendations by the Joint Committee on Vaccination and Immunisation, which advises the government on policy for vaccination in the UK. But Stubbins doesn’t think there will be any glitches in this respect. “I will be very surprised if JVCI does not make some recommendation,” he said at the meeting. “Gardasil has demonstrated a health economic advantage.”
The vaccine’s potential was indeed quickly recognised by EU regulators, which gave it a green light in just nine months. According to Watson, Gardasil’s extensive clinical trial program, which involved 25,000 women, its exceptional efficacy (100%) and the huge disease burden of cervical cancer helped speed its approval.
Gardasil will likely soon face competition from GlaxoSmithKline’s Cervarix, which was submitted in Europe last March. But, unlike Cervarix, Gardasil offers the benefit of tackling genital warts too, and this, together with its first-to-market advantage, could provide it with a competitive edge over its rival, helping it achieve the $3 billion peak sales target forecast by analysts.