Gardasil vs Cervarix - winner gets UK supply contract
Cervarix as they begin to battle it out to win a more than £100m a
year supply contract with the UK Department of Health.
Health secretary Alan Johnson announced the department will introduce a human papilloma virus (HPV) immunisation programme to routinely vaccinate girls aged 12 and 13 - and up to the age of 18 - against cervical cancer, starting from September 2008. As yet the department has not decided which vaccine to use: Merck's and Sanofi Pasteur's Gardasil or GlaxoSmithKline's Cervarix. Speaking to in-PharmaTechnologist.com, a Department of Health spokeswoman said the decision would be made in "due course" but the Joint Committee on Vaccination and Immunisation (JCVI) had no preference at this time. The decision would be made on price comparisons, effectiveness, and vaccine supply, the spokeswoman said. The initial contract up for grabs is worth £100m (€143.5m) a year, which would be used to vaccinate, on a non-compulsory basis, some 356,000 12 year olds and 364,000 13 year olds, according to projected statistics for mid-2007 from the Office for National Statistics. Johnson said there would also be a two-year catch up campaign starting in autumn 2009, for girls up to 18 years. This catch up programme could cost up to £200m in 2009/2010 and 2010/2011, though the Department of Health aims to negotiate a reduction in vaccine price during the procurement process, the department said in a statement. The move to include an HPV vaccine in the national immunisation programme follows advice of the JCVI, which recently made recommendations to the department that the vaccine should be made available to girls between the ages of 12 and 18. Cervarix was approved in Europe last month and has already been launched in the UK where it is priced at the same level as rival Gardasil, which was approved in the middle of last year. Results from Cervarix studies have shown 100 per cent protection against precancerous lesions caused by HPV types 18 and 16, which are responsible for 70 per cent of all cervical cancer cases worldwide. Cervarix has been formulated with GSK's novel AS04 adjuvant system which uses aluminium hydroxide combined with a novel substance known as monophosphoryl lipid A (MPL). MPL has been shown to activate key immune responses and enhance the response. In clinical trials, Cervarix adjuvanted with AS04 compared to the same antigens adjuvanted with aluminium hydroxide alone showed antibody titres at least two fold higher (analysed up to four years after first dose), 'significantly higher' functional antibody titres (analysed up to four years after first dose), and B cell memory frequency approximately two fold higher (analysed up to two years after first dose). Gardasil uses traditional aluminium salt-based adjuvants. Gardasil, which also protects against 90 per cent of genital warts cases, has also shown to provide 100 per cent protection against cervical cancer. GSK announced in January that the company would be initiating and funding a head-to-head trial between Cervarix and Gardasil. Over 1,000 women will be taking part in the trial, which will compare immune responses to cancer-causing virus types 16 and 18 in various age groups, as well as immune responses to other cancer-causing virus types. The immunisation programme could potentially save 400 lives a year - currently there are more than 2200 cases of cervical cancer a year, with about 800 deaths.
