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1 Core Ethics Vol. HPV WHO, FDA, PMDA,, Harald zur Hausen human papilloma virus HPV zur Hausen H Ian Frazer HPV Zhou J, Sun HPV HPV HPV, HPV, FDA Food and Drug Administration: EU FDA Hanly, Sharon Pharmaceuticals and Medical Devices Agency PMDA HPV a HPV a HPV b HPV WHO

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8 Core Ethics Vol. Adverse Event a Vaccine Adverse Event Reporting System: VAERS VAERS.p- VAERS VAERS FDA WHO GACVS HPV WHO FIGO HPV FIGO CRPS CRPS HPV CRPS WHO FIGO HPV CRPS CRPS HPV HPV HPV HPV

9 HPV FDA.. FDA Licensure of Bivalent Human Papillomavirus Vaccine HPV, Cervarix for Use in Females and Updated HPV Vaccination Recommendations from the Advisory Committee on Immunization Practices ACIP... FIGO.. FIGO statement on HPV vaccination Safety,Augast nd, PHARM STAG.Vol..No... %B %BB%E %A %.... HPV HPV HPV Translational research e_.pdf....a. HP HPV HP r wdd-att/ r rqg.pdf....c. rt zv.html....a r g f.html....d. Q&A.. r g f-att/ r hu _.pdf... PMDA... Sharon Hanley.. HPV. WHO HPV _Basic_Concept_of_Vaccination_jp.pdf... WHO.. Human papillomavirus vaccines WHO position paper, Weekly epidemiological record, No. : - WHO..GACVS Safety update on HPV Vaccines Geneva, June Zhou J,Sun XY,Stenzel DJ.. Expression of vaccinia recombinant HPV L and L ORF proteins in epithelial cells is sufficient for

10 Core Ethics Vol. assembly of HPV virion-like particles.virology... - Zur Hausen H.. Human papillomaviruses in the pathogenesis of anogenital cancer.virol ; : -

11 HPV Factors of Recurring Side Reactions of HPV Vaccine in Japan: Examining Perspectives of WHO, FDA, PMDA & MHLW at Times of Introducing HPV Vaccine IWATANI Sumika Abstract: Recurring side reactions of HPV vaccine have become a problem in Japan. As the first step to explore factors behind such reactions, this article examines how Japan and international organizations have evaluated effects of HPV vaccine at times of its introduction. Based on archival research and reports on the current situation of the side reactions, this paper analyzes multiple causes behind this problem. The research finds the following three major causes. First, Japan and international organizations guaranteed the safeness of HPV vaccine at the times of its introduction. Second, there has been no internationally standardized system to conceptualize and report on the side reactions of HPV vaccine. The lack of a standardized system makes it difficult to make a comparison across different countries, and thus to determine whether Japan has an unusually high number of recurring side reactions or other countries have less cases. Third, Japan heavily relied on clinical trial data obtained abroad even though the frequency of side reactions may vary from country to country. It is possible that the high frequency of the side reactions was induced primarily because Japan decided to use HPV vaccine without producing its own data. Keywords: HPV vaccine, side reaction, WHO, public health HPV HPV WHO, FDA, PMDA, HPV HPV HPV

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