Cervarix, which is already available in Australia and Sweden, was given the green light in Europe last month and the company has wasted no time in getting it out to potential users - with a launch yesterday in its home market, the UK, where it is priced at the same level as rival Merck & Co/Sanofi Pasteur MSD's Gardasil.
Cervarix was filed in the key US market in March but is not likely to be made available there until 2008 at the earliest.
A GSK spokesman told in-PharmaTechnologist.com that prequalification status can only be applied for three times a year - in January, May and September - which is why it has taken this step so quickly after being given the go-ahead in Europe; prequalification can only be sought once a product has been granted approval by a recognised drug regulator.
"It is the most effective way to access GSK's tiered pricing system," he added, pointing out that it means that rather than individual countries in the developing world having to review the data, this stage is conducted by the WHO over a year-long process, following which it may endorse the product for procurement by UN agencies and the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunisation), as well as for mass vaccination programmes across the developing world.
Under tiered pricing, GSK offers low-cost vaccines to major purchasers like UNICEF and the GAVI Alliance, as well as individual countries, based on their national income, the volume of doses ordered and the length of the contract.
Added Jean Stéphenne, President and General Manager of GSK Biologicals: "By submitting Cervarix for prequalification as early as possible, we are working to eliminate the historical 15-20 year delay for new vaccines to become available in developing countries."
The prequalification programme was created by the WHO in 2001 to increase access to priority medicinal products that meet unified standards of acceptable quality, safety and efficacy, with a particular focus on those used for HIV/AIDS, malaria, tuberculosis and for reproductive health. Acceptance to this list also confirms a manufacturer's ability to fulfil large-scale UN tenders.
The spokesperson told in-PharmaTechnologist.com that no trials of Cervarix have yet been conducted in Africa, but that the submitted dataset contains the results from studies in a broad patient population of 30,000 females - one third of which were in Asia - showing 100 per cent protection against precancerous lesions caused by human papillomavirus types 18 and 18, which are responsible for 70 per cent of all cervical cancer cases worldwide.
There are more than 270,000 deaths each year from cervical cancer and 85 per cent of these occur in the developing world. Cervical cancer is the second leading cause of cancer in women.
Meanwhile, rival Sanofi Pasteur MSD said yesterday that it is seeking expanded labelling for Gardasil to combat vulvar and vaginal cancers caused by the human papillomavirus types 16 and 18.
The company sought prequalification from the WHO for Gardasil in May.
