Real-world impact and effectiveness assessment of the quadrivalent HPV vaccine: a systematic review of study designs and data sources

Introduction Vaccine effectiveness and impact studies are typically observational, generating evidence after vaccine launch in a real-world setting. For human papillomavirus (HPV) vaccination studies, the variety of data sources and methods used is pronounced. Careful selection of study design, data capture and analytical methods can mitigate potential bias in such studies. Areas covered We systematically reviewed the different study designs, methods, and data sources in published evidence (1/2007-3/2020), which assessed the quadrivalent HPV vaccine effectiveness and impact on cervical/cervicovaginal, anal, and oral HPV infections, anogenital warts, lesions in anus, cervix, oropharynx, penis, vagina or vulva, and recurrent respiratory papillomatosis. Expert opinion The rapid growth in access to real-world data allows global monitoring of effects of different public health interventions, including HPV vaccination programs. But the use of data which are not collected or organized to support research also underscore a need to develop robust methodology that provides insight of vaccine effects and consequences of different health policy decisions. To achieve the WHO elimination goal, we foresee a growing need to evaluate HPV vaccination programs globally. A critical appraisal summary of methodology used will provide timely guidance to researchers who want to initiate research activities in various settings.

Automated summary

Observational studies on vaccine effectiveness and impact are crucial for assessing the real-world effects of vaccines, with careful selection of study design, data sources, and analytical methods to mitigate bias. Global monitoring of public health interventions like HPV vaccination programs is becoming easier with access to real-world data, but robust methodology is needed to ensure accurate evaluation of vaccine effects and health policy decisions. A critical appraisal of methodology used in these studies can guide future research and evaluation of HPV vaccination programs globally.