EC approves 2-dose Cervarix vaccine for Cervical Cancer-GSK

The European Commission has granted marketing authorisation for Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], from Glaxo Smith Kline, as a two-dose vaccine schedule for girls aged 9 to 14. This is the first time a Cervical Cancer vaccine has been approved as a reduced dosing schedule. Approval 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 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.