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December 24, 2013

GSK obtains European approval for Cervarix two-dose schedule

GlaxoSmithKline (GSK) has received marketing authorisation from the European Commission for its cervical cancer vaccine Cervarix as a two-dose schedule for girls aged nine to 14 years.

Cervical cancer

GlaxoSmithKline (GSK) has received marketing authorisation from the European Commission for its cervical cancer vaccine Cervarix as a two-dose schedule for girls aged nine to 14 years.

Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] 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.

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."

Approval is based on the results of two clinical trials HPV 048 and HPV 070 which evaluated both the immunogenicity and the safety of two doses of Cervarix.

The results from these two studies showed that two doses of Cervarix in nine to 14 year old girls is comparable with three doses in 15 to 25 year old girls and women.

The company said that the data looked not only at vaccine types 16 and 18 but also at non-vaccine types 31 and 45.

In the HPV-048 trial, these results were sustained for a total of four years.

In the EU, Cervarix is already approved for use in females from the age of nine years, administered 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.

Cervarix two-dose schedule in girls aged nine-14 years is already approved in 12 countries, which are Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan and Bangladesh.


Image: High-grade dysplasia (carcinoma in situ) in the uterine cervix. Photo: courtesy of Haymanj.

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