Impact of vaccination with Cervarix (trade mark) on subsequent HPV-16/18 infection and cervical disease in women 15-25 years of age.

Cervical cancer of both squamous and adenocarcinoma types is considered virtually 100% attributable to human papillomavirus (HPV) infection. HPV-16 and -18 are the predominant types worldwide accounting for over 70% of all cervical cancer. Persistent oncogenic HPV infection has been confirmed as one key determinant in the development of cervical precancer (cervical intraepithelial neoplasia [CIN] 2+) and cervical cancer. The impact of prophylactic HPV vaccination on the reduction of virological and cytohistological outcomes related to HPV-16 and -18 has been evaluated in clinical trials with the HPV-16/18 AS04-adjuvanted cervical cancer vaccine (Cervarixtrade mark) through a Phase IIb study with a long-term follow-up of efficacy up to 5.5 years, and a large Phase III trial in women 15-25 years of age. These individual studies include populations with different underlying risk factors, each of which shows high efficacy against both HPV-16/18 persistent infections and CIN2+. When the two studies are combined and the respective populations are evaluated, vaccine efficacy against HPV-16 and -18-related CIN2+ remains at 100%. As this vaccine is used over time in universal prophylactic HPV-16/18 vaccination of girls and women, reductions in cervical cancers at both the individual and public health levels will be appreciated.