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

ABSTRACT

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.

KEYWORDS:

• Human papillomavirus
• real-world evidence
• study design
• vaccine effectiveness
• vaccine impact

Funding

This work was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD). As MSD employees are among the co-authors, the sponsor had a role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Declaration of interests

W Wang, S Kothari, C Velicer, J Tota and A Sinha are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD), and may own stock in Merck & Co., Inc., Kenilworth, NJ, USA; M Baay, J Skufca and T Verstraeten are employees of P95 and have received consulting fees from vaccine-producing companies, including MSD; SM Garland has received grants through her institution from Merck and has delivered lectures, received speaking fees from MSD for work performed in her personal time and is a member of the Merck HPV Global Advisory Board. ARG has received financial support from Merck for her role as a member of several advisory boards and as a speaker at conference symposia and has received research grants through her institution. M Nygard has received research grants from MSD Norway through her affiliating institute. K Ssundstrom has received research grants from MSD to her institution. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

W Wang, S Kothari, and T Verstraeten designed the study. The data were acquired and analyzed by J Skufca, M Baay, T Verstraeten, and W Wang. All authors contributed to the interpretation of the results. W Wang, S Kothari, J Skufca, M Baay, and T Verstraeten drafted the manuscript. All authors critically reviewed and revised earlier versions and approved the final version of the manuscript.

Supplementary material

Supplemental data for this article can be accessed here