Post-licensure monitoring of HPV vaccine in the United States

ECDC comment

Markowitz LE et al. Vaccine 2010; 28: 4731-4737In this paper, the authors review plans for post-licensure monitoring of HPV vaccine in the United States, including those for monitoring vaccine coverage, vaccine safety and vaccine impact.

Markowitz LE et al. Vaccine 2010; 28: 4731-4737

This paper is a review of systems in place or being established for post-licensure monitoring of HPV vaccine in the United States. Two human papillomovirus (HPV) vaccines have been licensed and recommended for use in females in the United States, a quadrivalent human HPV vaccine, licensed in 2006 and a bivalent vaccine HPV vaccine licensed in 2009. HPV vaccination has been recommended for females 11 or 12 years of age with catch-up vaccination through age 26 years. Post-licensure monitoring of the HPV vaccine program has included some of the same systems established for other vaccines, such as those for vaccine safety and coverage monitoring. However, monitoring HPV vaccine impact on infection and disease outcomes requires new efforts. While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical precancers and genital warts.

No statements were made with regard to funding and potential conflict of interest.

ECDC comment:

Through this review, we have a detailed description and view of all plans and tools in use in the United States to evaluate the effect of HPV immunization program. For all here presented monitoring systems there are benefits and challenges. Methods and strategies for monitoring the impact of the HPV vaccine have been discussed by several experts during a meeting that took place at WHO Headquarters, last November (report available at It appears clear that to provide complete and accurate data to support policy and recommendations, new efforts and synergies among different professionals are required, moreover considering the several HPV-associated biologic outcomes (cancer, precancer, warts).