GlaxoSmithKline (GSK) has submitted a regulatory application in the European Union for a two dosing schedule in nine to 14 year old girls for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].
A marketing authorisation application (MAA) has been submitted to the European Medicines Agency (EMA) for the vaccine to allow for administration according to a two-dose schedule (0,6 months) in girls aged nine to 14 years old for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.
The vaccine is currently approved in the EU for use in females from the age of nine years, administered according to a three dose schedule (vaccination at months 0, 1 and 6) for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. The two-dose schedule in nine to 14 year old girls is intended to be an alternative dosing schedule and not intended to replace the three-dose schedule.
The use of Cervarix in a two dose schedule (vaccination at months 0 and 6) in girls aged nine to 14 years old is investigational and not approved anywhere in the world.
GlaxoSmithKline Vaccines is active in vaccine research and development. Of the 883 million doses of our vaccines we distributed in 2012, over 80 per cent went to developing countries, which include the least developed, low- and middle-income countries.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.