EU Approves Reduced Dosing for GSK's HPV Vaccine
Mon, 12/23/2013 - 9:50am
GlaxoSmithKline (GSK) announced that the European Commission has granted marketing authorization for its cervical cancer vaccine Cervarix as a two-dose schedule for girls aged 9 to 14. This is the first time a cervical cancer vaccine has been approved as a reduced dosing schedule and signifies potential for greater vaccination coverage rates and improved cervical cancer protection worldwide.
Thomas Breuer, senior vice-president and lead physician, GSK Vaccines, said “We’re delighted to receive approval for Cervarix as a 2-dose schedule. 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.”
The EU approval of Cervarix as a 2-dose schedule is based on the results of two clinical studies HPV 048 and HPV 070 which assessed both the immunogenicity and the safety of two doses of Cervarix. The findings from these two studies were consistent and demonstrated that 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. This data looked not only at vaccine types 16 and 18 but also at non-vaccine types 31 and 45. In study HPV-048, these results were sustained for a total of four years.
The vaccine is already approved in the EU for use in females from the age of 9 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 (0, 6 months) will apply to vaccination of girls aged 9-14. The three-dose schedule remains in the label for girls and women aged 15 years and above.
Outside of the EU, Cervarix two-dose schedule in girls aged 9-14 years is already approved in twelve countries, including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan and Bangladesh. Cervarix is also approved in the US.
Date: December 20, 2013