PMID- 32572770
OWN - NLM
STAT- MEDLINE
DCOM- 20210603
LR  - 20210603
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 55
IP  - 1
DP  - 2021 Jan
TI  - Alternative New Mono-scaled Quantitative Benefit-Risk Assessment of Human 
      Papillomavirus Vaccine in Japan.
PG  - 48-55
LID - 10.1007/s43441-020-00189-1 [doi]
AB  - BACKGROUND: The human papillomavirus (HPV) vaccine coverage is very low in Japan 
      since the government suspended the active encouragement of the vaccination. We 
      aimed to conduct a benefit-risk assessment of HPV vaccination and explore 
      different consequent scenarios to identify potential improvements to the current 
      Japanese immunization program. METHODS: To calculate social benefit-risk of HPV 
      vaccine, we used the Markov model to represent the natural history of HPV and 
      adverse events (AEs) using disability-adjusted life year (DALY) as the outcome. 
      Benefits and risks were calculated as the sum of negative and positive outcomes 
      corresponding to all preventable diseases and AEs associated with HPV 
      vaccination, respectively. The benefit-risk balance in 2050 was estimated using 
      published data. RESULTS: Our model was confirmed by published cervical cancer 
      incidence and mortality rates. The benefit-risk balance in 2050 showed that the 
      most effective scenario was the introduction of 9-valent HPV vaccine targeting 
      female individuals aged 10-29 years for routine vaccination starting in 2020, 
      although there is possibility of increased risks of AEs for the vaccinated age 
      group post resumption of recommendations. CONCLUSION: Our benefit-risk assessment 
      of HPV vaccine helped estimate various scenarios pertaining to HPV vaccination 
      and identify the best strategy regarding HPV vaccination. This benefit-risk 
      assessment approach may be used for other vaccines and vaccination programs.
FAU - Matsumoto, Tomoko
AU  - Matsumoto T
AD  - Global Regulatory Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, 
      Gifu, 501-1196, Japan.
AD  - Syneos Health Clinical K.K., 2-1-3 Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan.
FAU - Matsumaru, Naoki
AU  - Matsumaru N
AD  - Global Regulatory Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, 
      Gifu, 501-1196, Japan.
FAU - Scuffham, Paul
AU  - Scuffham P
AD  - Centre for Applied Health Economics, Menzies Health Institute Queensland, 
      Griffith University, Brisbane, QLD, 4111, Australia.
FAU - Neels, Pieter
AU  - Neels P
AD  - Vaccine-Advice BVBA, Sint-Antoniusbaan 281, 2980, Zoersel, Belgium.
AD  - Universite de Namur, Namur, Belgium.
FAU - Tsukamoto, Katsura
AU  - Tsukamoto K
AUID- ORCID: 0000-0002-5827-3090
AD  - Global Regulatory Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, 
      Gifu, 501-1196, Japan. tsukamoto@gifu-pu.ac.jp.
LA  - eng
PT  - Journal Article
DEP - 20200622
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Cost-Benefit Analysis
MH  - Female
MH  - Humans
MH  - Japan
MH  - Papillomavirus Infections/prevention & control
MH  - Papillomavirus Vaccines
MH  - *Risk Assessment
MH  - Young Adult
OTO - NOTNLM
OT  - Benefit-risk assessment
OT  - Disability-adjusted life years (DALY)
OT  - Disease burden
OT  - HPV
OT  - Vaccine decision-making
EDAT- 2020/06/24 06:00
MHDA- 2021/06/04 06:00
CRDT- 2020/06/24 06:00
PHST- 2019/12/19 00:00 [received]
PHST- 2020/06/11 00:00 [accepted]
PHST- 2020/06/24 06:00 [pubmed]
PHST- 2021/06/04 06:00 [medline]
PHST- 2020/06/24 06:00 [entrez]
AID - 10.1007/s43441-020-00189-1 [pii]
AID - 10.1007/s43441-020-00189-1 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2021 Jan;55(1):48-55. doi: 10.1007/s43441-020-00189-1. Epub 
      2020 Jun 22.