Gardasil now approved in 80 countries

Sanofi Pasteur MSD's says that one year after its US launch, the four-type human papillomavirus vaccine Gardasil has been approved in 80 countries and launched in almost 60 of them. According to co-parent company Merck & Co, approval was often granted under accelerated review times, in the USA for instance under a fast track review of six months and in the European Union after only nine months compared to a usual review time of 13 to 15 months. Additional applications are under review in approximately 40 other countries.

Many countries, including the USA, Canada, Australia and several European Union member states, already recommend routine HPV vaccination for pre-adolescent girls, usually coupled with catch up programs for adolescent girls and young women. Several of these countries, including the USA, Australia, Germany, France, Sweden and Italy, also already reimburse vaccination or have started publicly-funded vaccination programs.

World Health Organization certification for the procurement by United Nations agencies, an important step towards providing global access, in particular in the developing world, is under review.