WHO Grants Prequalification To GSK’ Cervarix

The World Health Organization (WHO) has awarded prequalification to Cervarix, GlaxoSmithKline’ (GSK) cervical cancer vaccine.

GSK filed Cervarix for WHO prequalification in September 2007, less than one week after the vaccine was approved by the European Medicines Agency. Registration with a major regulatory agency is a required step for any WHO prequalification filing.

Jean Stephenne, President of GSK Biologicals, said: “Cervarix can save millions of women’s lives throughout the world, but only if it reaches those who need it most. That is why GSK rapidly applied for WHO prequalification of Cervarix. That is why we’re eager to work with our long-term partner GAVI as well as other private NGOs or governments of developing countries to identify financing mechanisms for the vaccine. And that is why we’re exploring a variety of distribution partnerships to ensure Cervarix will protect women and girls around the globe.”

To overcome the challenges of introducing a cervical cancer vaccine in developing countries, GSK is participating in a number of HPV vaccination demonstration projects, including those led by PATH in Uganda and India. It has donated more than 100,000 doses of Cervarix to these programs. These collaborations would help build and leverage developing countries’ experience with the implementation of HPV vaccination programs, said the company.

Christopher Elias, President and CEO of PATH, said: “Through our joint demonstration project, we have found that we can achieve high HPV vaccination coverage through proper sensitisation, the strengthening of healthcare systems and the mobilisation of local communities. With today’s WHO decision, the public and private sectors take another significant step forward in accelerating access to HPV vaccines in GAVI countries. We look forward to continuing to partner with GSK on this public health priority.”