GSK seeks WHO prequalificaiton for Cevarix

GlaxoSmithKline (GSK) has applied for prequalification for Cervarix from the World Health Organisation (WHO) after the cervical cancer vaccine was approved by European regulators last month.

WHO prequalificaiton facilitates the faster delivery of vaccines to developing nations following their approval from a recognised regulatory body.

Additionally, such prequalification denotes public health support of the efficacy and safety of the vaccine and the ability of the pharmaceutical firm to execute tenders for the United Nations on a large scale.

Cervarix – formulated with the AS04 proprietary adjuvant system – enhances the immune response against cancer-causing forms of the human papillomavirus

Jean Stephenne, president and general manager of biologicals at GSK, said: “GSK believes that people in developing countries should have rapid access to life-saving vaccines once they are approved.

“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.”

He added that this decision highlights the company’s ongoing relationship with the Gavi Alliance and Unicef, a partnership that also encompasses the firm’s tiered pricing initiative.

In June 2007, GSK reported the results of a phase III clinical trial showing a 100 per cent response rate to Cervarix following administration with a three-dose regimen of vaccination.