Understanding the public health value and defining preferred product characteristics for therapeutic human papillomavirus (HPV) vaccines: World Health Organization consultations, October 2021-March 2022.

The World Health Organization (WHO) global strategy to eliminate cervical cancer (CxCa) could result in >62 million lives saved by 2120 if strategy targets are reached and maintained: 90% of adolescent girls receiving prophylactic human papillomavirus (HPV) vaccine, 70% of women receiving twice-lifetime cervical cancer screening, and 90% of cervical pre-cancer lesions and invasive CxCa treated. However, the cost and complexity of CxCa screening and treatment approaches has hampered scale-up, particularly in low- and middle-income countries (LMICs), and new approaches are needed. Therapeutic HPV vaccines (TxV), which could clear persistent high-risk HPV infection and/or cause regression of pre-cancerous lesions, are in early clinical development and might offer one such approach. During October 2021 to March 2022, WHO, in collaboration with the Bill and Melinda Gates Foundation, convened a series of global expert consultations to lay the groundwork for understanding the potential value of TxV in the context of current CxCa prevention efforts and for defining WHO preferred product characteristics (PPCs) for TxV. WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper reports on the main discussion points and findings from the expert consultations. Experts identified several ways in which TxV might address challenges in current CxCa prevention programmes, but emphasized that the potential value of TxV will depend on their degree of efficacy and how quickly they can be developed and implemented relative to ongoing scale-up of existing interventions. Consultation participants also discussed potential use-cases for TxV, important PPC considerations (e.g., vaccine indications, target populations, and delivery strategies), and critical modelling needs for predicting TxV impact and cost-effectiveness.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: From the full list of authors, the following have declared potential conflicts of interest; Celina Schocken is currently conducting consultation work on HPV diagnostics for Roche Diagnostics; Margaret Stanley has provided consultancy services for Merck Pharmaceuticals. Karen Canfell, who is leading the modelling effort for this work is Co-principal investigator (Co-PI) on a cervical cancer trial, funded by VCS (a non-profit foundation) which is also supported by Roche Diagnostics. She also acts as Co-PI for a study on the elimination of CxCa, which is supported by Minderoo Foundation Frazer Family Foundation, which is supplied with equipment and donations from Cepheid Inc. Gina Ogilvie, as part of a regulatory, legislative or judicial process has provided expert opinion or testimony related to the subject of the meetings and work for a commercial entity (not specified), and in addition has held office or other position in which she has represented interests or defended a position relating to the subject matter (unspecified). Luisa Lina Villa provides consultancy services and has spoken on behalf of Merck Pharmaceuticals on the topic of prophylactic HPV vaccines. All participants in the Therapeutic HPV Vaccine PPC Expert Consultations completed WHO Declaration of Interests statements, and their participation in these meetings and commenting on aspects of the PPC development were in accordance with the Organization’s guidelines for Declaration of Interests for WHO experts. Where authors are identified as personnel of the International Agency for Research on Cancer/World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer/World Health Organization.
(Copyright © 2022. Published by Elsevier Ltd.)