Background. Hundreds of millions of HPV vaccine doses have been administered globally. Post-marketing surveillance studies have confirmed initial observations in clinical trials of a strong safety record. Yet, concerns regarding the safety of the HPV vaccines continue to impede their use. Learning Objectives. The main objective of this session is to understand the status of the safety data for HPV vaccines, and the different sources used to generate these data. Participants will learn to interpret results from safety analyses, and to discern true signals of concern from anecdotes and scare tactics. The specific objectives are to review and understand: 1)Different sources of vaccine adverse event data, and the methodologic approaches used for analyzing the data; 2)Rigorously-collected and interpreted safety data from the USA, Australia and globally; 3)Safety concerns regarding HPV vaccination in Japan; and, 4)Distinguishing true safety concerns from anti-vaccine misinformation and appropriate messaging of vaccine safety data. Presentations and potential speakers. 90 min total Introduction to HPV vaccine monitoring- Suzanne Garland Vaccine safety monitoring in the USA: approaches and resultsLauri Markowitz Vaccine safety monitoring in Australia: approaches and results. Kristine Macartney Vaccine safety monitoring by the WHO: approaches and results. Paul Bloem or WHO representative Scientific evaluation of alleged findings in HPV vaccines in Japan. Ikuo Tsunoda Messaging HPV vaccine safetyAlex Vorsters Discussion. Toshiyuki Sasagawa

Session won’t be live-streamed to the IPVC virtual platform, but will be recorded onsite for viewing on-demand later via the platform.Objectives; To consider additional actions needed to improve efficacy of therapeutic HPV vaccine. Session time; 90 mins. The prophylactic HPV vaccine is unable to eliminate HPV-related CIN/2/3 or cervical cancer, although it is effective to reduce the incidence of these lesions in many countries. The therapeutic HPV vaccine aims to induce HPV-specific cytotoxic T-lymphocytes killing HPV-positive cells. Various therapeutic vaccines had been developed, and some could clear CIN2/3 in more than a half of the cases, while it is less effective to cancer. It is noted that immune-suppression is induced in the microenvironment of cancer tissue. Prof. Hibma examines expression of many immune markers in human tissues using histochemical analysis, and shows which markers are useful to predict immune responses important for regression or progression of CIN2 lesions in young women. Prof. Taniguchi studies damage-associated molecular pattern (DAMPs) molecules and toll-like receptors (TLRs), and teaches us about how DAMP and TLR interactions sculpt the tumor immune microenvironment to favor tumor growth would identify new strategies and approaches for cancer immunotherapy. Prof. Sugiyama developed a cancer immune therapy targeting WT-1. He shows how the WT1 cancer vaccine is effective in various patients with advance-staged cancer. BCG-CWS was used as an adjuvant in some cases. Recently it is reported that gamma delta (γδ) T cells undergo rapid expansion after BCG vaccination due to MHC-independent mechanisms. This may be one important mechanism of BCG-CWS to clear cancer.