GlaxoSmithKline has submitted a file on its cervical cancer vaccine, Cervarix, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.
WHO designed the pre-qualification mechanism to speed the delivery of new vaccines to developing countries (and where they are needed most), once the vaccines have received approval from a recognised national regulatory authority. With three opportunities for submission a year, prequalification functions as a public health endorsement of a vaccine's efficacy, safety and quality and confirms the manufacturer's ability to fulfil large-scale UN tenders. Products with prequalification status may be used by UN agencies and the GAVI Alliance, as well as mass vaccination programmes across the developing world.
"GSK believes that people in developing countries should have rapid access to life-saving vaccines once they are approved," said 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. This move is the latest example of GSK's longstanding partnership with UNICEF and the GAVI Alliance, including our tiered pricing programme, which we pioneered more than 20 years ago".
Worldwide a woman dies of cervical cancer every two minutes resulting in more than 270,000 deaths each year.1 85 per cent of deaths from cervical cancer occur in the developing world where, in the absence of regular screening and treatment programmes, it is the leading cause of cancer deaths in women.
"Cervical cancer vaccines represent a major medical breakthrough and have the potential to transform women's health, particularly in resource-poor countries," said Dr Nono Simelela from the International Planned Parenthood Federation. "Prequalification would help speed access to this important new tool for girls and women across the world at risk for cervical cancer. Along with increased awareness and improvements in screening and treatment, cervical cancer vaccines will help save and improve the lives of millions of women".
GSK Biologicals has a long-standing commitment to preventing diseases prevalent in the developing world. As with its other vaccines, GSK will provide its cervical cancer vaccine at preferential prices to low income countries. GSK's unique business model is designed to ensure availability of its vaccines regardless of where people live. 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.
GSK has developed Cervarix to protect women from cervical cancer by guarding against the most common cancer-causing forms of the human papillomavirus (HPV). Clinical trials involving almost 30,000 females demonstrated excellent efficacy and immunogenicity data.