The European Commission has granted marketing authorization for GlaxoSmithKline's (GSK) cervical cancer vaccine Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] as a two-dose schedule for girls aged 9 to 14.
Cervarix is the first cervical cancer vaccine to be approved as a reduced dosing schedule and signifies potential for greater vaccination coverage rates and improved cervical cancer protection across the world.
GSK Vaccines senior vice-president and lead physician Thomas Breuer said, "This new dosing schedule can make vaccination easier to implement and more affordable, which in turn creates the potential for higher vaccination coverage and more girls being protected against cervical cancer," Breuer said.
The EU approval is based on two clinical trials results including HPV 048 and HPV 070 which assessed both the immunogenicity and the safety of two doses of Cervarix.
As per the results of both the studies, two doses of Cervarix in 9 to 14 year old girls is comparable to three doses in 15 to 25 year old girls and women.
According to the company, the data looked not only at vaccine types 16 and 18 but also at non-vaccine types 31 and 45.
Cervarix is already approved in the EU for use in females from the age of 9 years, given according to a three-dose schedule for the prevention of premalignant genital lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.
The vaccine in girls aged 9-14 years is already approved in 12 countries including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan and Bangladesh.