1 1.1 ワクチンの定義 Variolae vaccinae 1798 1 1. A B b Hib 2 1 4 2012

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1 3 23 1.2 4 3 A B DTaP Tdap bhib 2 HPV H1N1 3. 2 AS04 A MF59 2 2. 1... http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228#t2 2... http://www.cdc.gov/vaccinesafety/concerns/adjuvants.html. 2011 6 7 2012 7

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1 3 7 11 1798 Variolae vaccinae Vaccination vaccinae 19 1885 1886 20 20 L http://en.wikipedia.org/wiki/file:jenner-statue-by-lachlan-mvc-006f.jpghttp://en.wikipedia.org/wiki/file:tableau_louis_pasteur.jpg 3 S L, S A.. 5, S, W, P,,, 2008. 2012 11

1.2 ワクチンで予防可能な疾患の調査 2 100 20 20 21 20 10 AIDS RS Respiratory syncytial virus RSV 25 4 120 4 45 40 35 30 25 20 15 10 5 0 1800 5 1910 1930 1950 1970 1990 2010 7. 1798 4... No 117. 2009 3. http://www.who.int/mediacentre/factsheets/fs117/en/ 12 2012

1 35 12 5 8 640 b 0 5 10 15 20 25 30 8. 2012 13

1798 1885 1976 1886 1983 1994 2008 1896 1991 1997 1897 4 1923 1926 1914 * 1981 1921 1932 1936 2003 1955 1962 23 1983 7 2000 4. ***Am9*** 14 2012

1 1963 1948 ** 1967 *** 1969 * 1974 2005 2006 * 1935 1988 1937 A 1995 1971 1981 4 1999 C 2005 4 b 1985 1987 B 1981 1986 1954 2006 3. 2012 15

AB B b A 5. 1971 1976 1977 1981 1982 B 1985 B 1986 B 1987 b 1988 B 1991 1992 1993 b 1994 1995 A A 1996 b BHib-HepB 2000 7 2001 AB 2002 B 2003 2005 MMRV MR 2006 2007 b 2010 7 2011 23 12 6. 1971 2011 16 2012

1 2012 17

1.3 ワクチンの有効性と安全性 5 20 89 100% 9 2 1011 1,200,000 1,000,000 800,000 600,000 400,000 200,000 0 2009 b 110 300 250 200 150 100 50 0 b Ja 1990 Ju 1990 Ja 1991 Ju 1991 Ja 1992 Ju 1992 Ja 1993 Ju 1993 Ja 1994 Ju 1994 Ja 1995 Ju 1995 Ja 1996 Ju 1996 Ja 1997 Ju 1997 Ja 1998 Ju 1998 Ja 1999 Ju 1999 Ja 2000 Ju 2000 Ja 2001 Ju 2001 Ja 2002 Ju 2002 9. 6, 7 10. Hib 8 300,000 250,000 1994 200,000 150,000 100,000 50,000 0 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 9, 10 11. S L, S A.. 5, S, W, P,,, 2008. 6. 1900 1999, 1990 1998. MMWR 48:243-248, 1999. http:// www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm 7., 2009. MMWR 58 (53): 85-87, 2011 5 13. http://www.cdc.gov/mmwr/pdf/wk/mm5853.pdf 18 2012

1 Efficacy 95% 12 12. 8 R A, O, G. bhib Hib. Lancet. 2005;366:144-50. 9 J K, C-... DC, 2010 7 27. 10. 1996 2008. http://www.paho.org/english/ad/fch/im/measles_numbercases.pdf 2012 19

Effectiveness 7 85% 83 94% 75 86% 92 94% 80 86% 80 85% 83 85% 7. 11 *11 Efficacy 12 13 Efficacy x 100 11.. http://www.bt.cdc.gov/agent/smallpox/training/overview/pdf/eradicationhistory.pdf 12 http://en.wikipedia.org/wiki/vaccine_efficacy 20 2012

1 100 13. 2012 21

Effectiveness Efficacy retrospecitive cohort study prospective cohort study 70% 100% 14 70 100% 4 8 5 6 A b 65 B 65 0 20 40 60 80 100 % 14. 3 22 2012

1 38 BCG 90 95% b 5 15% 2 10% B 15% 5% 1 6% 10% 5 15% 5% < 1% < 1% 10% 50 85% 10% 25% 50% 50% 8. 7 AEFI Adverse Event Following Immunization 9 > 1 / 10 > 1 / 100 < 1 / 10 > 1 / 1 000 < 1 / 100 > 1 / 10 000 < 1 / 1 000 < 1 / 10 000 9. AEFI 8 13. http://www.cdc.gov/vaccines/vpd-vac/diphtheria/default.htm#clinical, Immunization Action Coalition.. http://www.vaccineinformation.org/. 2011 6 7 14 S L, S A.. 5, S, W, P,,, 2008. 15. 9. 1.5.. http://www.health.gov.au/internet/immunise/publishing.nsf/content/handbook-adverse 16.. 2. http://www.phac-aspc.gc.ca/publicat/cig-gci/p02-01-eng.php 17..,,, 1999. http://www.who.int/immunization_safety/publications/aefi/en/aefi_wpro.pdf 18. 22. http://www.phac-aspc.gc.ca/publicat/cig-gci/p02-01-eng.php 2012 23

VAERS 24 2012

1 1.4 ワクチンの安全性監視と評価 I AEFI 50 ~ II 3 I ~ III II50 III Brighton collaboration 19 15. 3 IV 19 P A, R L, D.. pp 1630. 5, S, W, P,,, 2008. 2012 25

National Childhood Vaccine Injury Act NCVIA VAERS 10 VAERS Vaccine Adverse Event Reporting System VAERS1990CDC Centers for Disease Control and Prevention FDA Food and Drug Administration VAERS 2002 VAERS http://vaers. hhs.gov/index 24 VAERS 60 1 16VAERS AEFI 10. 20 National Immunization Survey 95 FDA CDC VAERS 16. 20 P A, R L, D.. pp 1631. 5, S, W, P,,, 2008. 26 2012

1 VAERS AEFI Adverse Events Following Immunization Vaccine Safety DataLink Project VSDHMO VI AEFI Commonwealth countriesaefi Immunization Monitoring Program Active IMPACT 90%12 21 AEFIAEFI Center for Immunization and Respiratory Infectious Diseases 17 12 AEFI ADFI 17. IMPACT 21.. http://www.phac-aspc.gc.ca/im/vs-sv/caefiss-eng.php 2012 27

AEFI 22 AEFI AEFI 23 AEFI EMA WHO 40AEFI WHO Global Advisory Committee on Vaccine Safety GACVS IV 18. CDC ) VIS WHO ) AEFI 22 E A, K R, S A M, F R M. 2011.. Rev Saude Publica. http://www.scielo.br/pdf/rsp/v45n1/en_1884.pdf 23 E A, K R, S A M, F R M. 2011.. Rev Saude Publica. http://www.scielo.br/pdf/rsp/v45n1/en_1884.pdf 28 2012

1 1.5 ワクチンによる健康被害の補償制度 AEFI AEFI AEFI 1970 1980 300 1 24 19761918 H1N1 1 Swine Flu Act 10 1986 National Childhood Vaccine Injury Act NCVIA VICP VICP 11 25 24 G, E M, E H.. pp 1654. 5, S, W, P,,, 2008. 25 Health Resources and Services Administration. http://www.hrsa.gov/vaccinecompensation/table.htm 2012 29

B 0 4 2 28 0 4 0 72 0 4 5 15 7 42 7 30 0 6 0 30 0 6 0 30 0 6 0 4 0 4 bhib CDC A 11. http://www.hrsa.gov/vaccinecompensation/table.htm 30 2012

1 VICP NCVIA VAERS VICP 16 VICPHHSDOJ Office of Special Masters Advisory Committee on Childhood Vaccines ACCV VICP ACCV VICP National Vaccine Advisory Committee NVACVICP 20 VICP 1 1 75 MMR$0.75 3 $2.25 21 26 1988VICP DTP 19 27 3000 2500 2000 1500 1000 500 0 1988 1990 1992 1994 1996 1998 2000 2002 2004 2008 2010 19. VICP 26... http://www.hrsa.gov/vaccinecompensation/ 27.... http://www.hrsa.gov/vaccinecompensation/statistics_report.htm 2012 31

NVAC HHS DOJ ACCV VICP VICP 20. HHS HHS 3 2 4 6 8 5 7 1 8 9 10 21. 32 2012

1 1. 2. 8 3. HHS VIT VIT 6 4. 5. 100% 6. 7. 8. 9. 10. 25120 910 VICP VICP http://www.hrsa.gov/ vaccinecompensation/ 28 19905,000 1 8,000 22 VICP VICP 29 200 180 160 200 180 160 140 120 100 80 60 140 120 100 80 60 100 40 40 20 20 0 0 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 22. VICPVICP 28.... http://www.hrsa.gov/vaccinecompensation/statistics_report.htm 29.... http://www.hrsa.gov/vaccinecompensation/statistics_report.htm 2012 33

1990 DTP DTP DTaP DTaP DTP 1988 2010VICP 23 DTaP DTP DTP MMR B OPV DTaP Td TT DT Tdap DTaP BIPV HPV Hib A MMRV IPV MR AB DTaP Hib BHib DTP Hib DTaP IPV Hib 0 500 1,000 1,500 2,000 2,500 3,000 23. VICP1988 2010 34 2012

1 19 24 30 1961 2005 1 1 50% 12 6 Bradford Hill 1963 1972 1974 1979 1985 1992 1995 2004 1961 1970 1973 1978 1984 1988 1994 2001 2005 24. 30 C, H.. Bull World Health Organ 2011; 89:371 378. http://www.who.int/bulletin/volumes/89/5/10-081901.pdf 2012 35

1.6 費用効果分析と評価 A 25 26 B C 25. 12 31 A B 26. 31 National Network for Immunization Information.. http://www.immunizationinfo.org/issues/immunization-policy/ vaccine-economics 36 2012

1 B 13 10% 713 1,660 32 DTP Hib DTP Hib B 9,000 1 5,000 35 1.0 7 5.3 16.5 27 33 WHO 34 12. A b B 0 5 10 15 20 25 30 27. 32 L D, R, B J.. Pharmacoeconomics 2005; 23(11): 1083-1106. 33 Committee on the Evaluation of Vaccine Purchase Financing in the United States, Board on Health Care Services.. 21., DC, 2004. 34.. http://www.who.int/topics/immunization/en/ 35 M A, A R.. pp 1597. 5, S, W, P,,, 2008. 2012 37

28 36 1 GNI 3 GNI 37 26 /QALY $1,000,000 $10,000 DALY QALY DALY QALY DALY QALY $100 $1 * *28 29 38, 39, 40 b A 4 $ / QALY $0 $50,000 $100,000 $150,000 29 QALY 0 12 36 F, J, M L. 7, 2001. Arch Pediatr Adolesc Med 159: 1136-1144, 2005. 37. WHO-CHOICE.. http://www.who.int/choice/costs/cer_thresholds/en/index.html 38 H. HPV. Advisory Committee on Immunization Practices. 2011 2 4 39 E, A P.. Vaccine 2009; 27:4025-4030. 40., 2011 7 1. http://siteresources.worldbank.org/datastatistics/resources/gnipc.pdf 38 2012

1 1.7 ワクチン実施のオプション Institute of Medicine 5 30 41 VFC 317 VFC VFC 30. 41 Committee on Immunization Financing Policies and Practices,.., DC, 2000. 2012 39

CDC Vaccine for Children VFC 55% VFC VFC 45% VFC VFC HMO Health Plan Employer Data Information Set HEDIS IIS CDC National Notifiable Disease Surveilance System 50 1 ECDC EURO 31. 40 2012

1 ECDC EU EU WHO EURO ECDC 31 EU EU EU PMDA EU ICHICH 3 PAHO 32 42 $50,000 16 $45,000 14 1 GNI 1 GNI $40,000 $35,000 $30,000 $25,000 $20,000 $15,000 $10,000 12 10 8 6 4 $5,000 2 $0 0 32. 42 T F, Z Y.. pp 1525 1539. 5, S, W, P,,, 2008. 2012 41

1.8 国の予防接種推奨システム National Immunization Technical Advisory Group NITAG 43 Advisory Committee on Immunization Practices ACIP 44 ACIP COID National Vaccine Advisory Committee NVAC 33 NVAC HHS CDC VFC AAP ACIP 15 ex.officio 9 33 AAFP 33. ACIP 43... http://www.who.int/immunization/sage/national_advisory_committees/en/index.html 44.. ACIP. ACIP. http://www.cdc.gov/vaccines/recs/acip/#about 42 2012

1 15ACIP HHS 2HHS CDC ACIP ACIP15 ex. officio 3435 HHSCDCACIP VFC 18 VFC Affordable Healthcare Act ACIP ACIP 34. ACIP 2012 43

ex. officio CDC 35. ACIP2011ACIP 44 2012

1 Australian Technical Advisory Group on Immunization ATAGI ATAGI Pharmaceutical Benefits Advisory Committee PBAC National Health and Medical Resarch Council 46 36 ATAGI PBAC ATAGI PBAC PBAC ATAGI 1,000 36. ATAGI ATAGI National Immunization Committee NIC Communicable Diseases Network Australia CDNAAustralian Drug Evaluation Committee ADEC Adverse Drug Reactions Advisory Committee ADRAC 45... ATAGI. http://www.health.gov.au/internet/immunise/publishing.nsf/content/advisory-bodies 46.. 20089. http://www.health.gov.au/internet/immunise/publishing.nsf/content/handbook-home 2012 45

ACIPATAGI 47 37 STIKO Joint Committee on Vaccines and Immunization JCVI 13 ACIP ex. officio 37. ATAGI 47... http://www.health.gov.au/internet/ministers/publishing.nsf/content/health-mediarel-yr2005-ta-abb128.htm?opendocument&yr=2005&mth=10 46 2012

1 ECI IVB Strategic Advisory Group of Experts SAGE SAGE IVB 49 NITAG SAGE WHOEPI NITAG 13 48 WHO WHO 1999 SAGE ACIP 15 ACIP SAGE GAVI WHO 38 SAGE2 WHO WER www.who.int/wer NITAG Australian Technical Advisory Group on Immunization ATAGI OSRImpfausschuss des OSR National Advisory Committee on Immunization NACI Comite technique de vaccin CTV Ständige Impfkommission STIKO Scientific Committee on Vaccine Preventable Diseases Immunization Committee of the Indonesian Pediatric Society National Immunization Advisory Committee RVPGezondheidsraad-Commissie RVP Expert Committee on Immunization ECI Eidgenössischen Kommission für Impffragen EKIF Advisory Committee on Immunization Practices ACIP Joint Committee on Vaccination and Immunisation JCVI Advisory Committee on Immunization Practices ACIP 13. NITAG 48... http://www.who.int/immunization/sage/national_advisory_committees/en/index1.html 49.. 2011 3 29. http://www.who.int/immunization/sage/sage_tor_part_1_annex_3_29_mar_2011.pdf 2012 47

GAVI WHO WHO NGOs 38. SAGE 50 48 2012

1 WHO SAGE 51 ACIP SAGE SAGE WHO http://www.who.int/immunization/position_papers/en/ 2532 52 50.. SAGE. http://www.who.int/immunization/sage/members/en/index.html 51.. WHO. http://www.who.int/immunization/position_papers/en/ 52 R G, J, V.. pp 37. 5, S, W, P,,, 2008. Knol. 2012 49