The World Health Organization (WHO) has awarded prequalification to Cervarix, GlaxoSmithKline’s cervical cancer vaccine. GlaxoSmithKline pharmaceutical company applied for WHO prequalification of Cervarix 2 years ago.
The WHO decision is necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and will help speed access to Cervarix globally.
More than 80 percent of the 280,000 cervical cancer deaths a year occur in resource-poor nations. Cervical cancer affects poor women in the least developed countries more often and more aggressively due to a lack of available screening services and the high prevalence of other serious health conditions such as HIV/AIDS.
“Cervarix can save millions of women’s lives throughout the world, but only if it reaches those who need it most,” said Jean St?phenne, President of GSK Biologicals. “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.”
Today’s WHO prequalification for Cervarix is the result of a rigorous regulatory process that began nearly two years ago. 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.
GSK’s track record of more than 10 WHO prequalified vaccines exemplifies the company’s long-standing prioritisation of global markets and commitment to making its vaccines available to populations in developing countries. The company recently received an extended WHO prequalification for another crucial vaccine, Rotarix? , opening the door to making rotavirus vaccines available to children worldwide. No fewer than five other GSK vaccines are currently under consideration for WHO prequalification.
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, and has donated more than 100,000 doses of Cervarix to these programme. These collaborations will help build and leverage developing countries’ experience with the implementation of HPV vaccination programmes.
Source: GlaxoSmithKline, USA