WHO/V&B/01.31 ORIGINAL: ENGLISH DISTR.: GENERAL
WHO/V&B/01.31
: www.who.int/vaccines-documents/ World Health Organization Department of Vaccines and Biologicals CH-1211 Geneva 27, Switzerland iFax: +41 22 791 4227iE-mail: vaccines@who.int i
©
ii
................................................................................................................. v ................................................................................................................... vi 1. 2. 2.1. 2.2. 2.3. 2.4. 3. 3.1 3.2 3.3 ..................................................................................................................... 8 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 ................................................................................................ 9 ........................................................................................................ 9 ........................................... 9 ............................................................................................. 10 .................................................................. 10 ............................................................................................................... 10 ............................................................................................... 10 .............................................................. 12 ................................................................................... 12 ................................................................................................. 12 ........................................................................................................... 13 ............................................................................................. 13 .............................................................. 15 ........................................................................................... 15 ............................................................................................................................... 1 ............................................................................................................ 2 ............................................................................. 2 ...................................................................................... 2 .......................................................................................................... 3 .......................................................................................... 5 ..................................................................... 6 .................................................................................... 6 ........................................ 7
iii
5. 5.1 5.2 5.3 5.4 5.5 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 7. 7.1 7.2 8. 8.1
..................................................................... 16 " .......................................................................................................... 16 " ............................................................................................. 17 " ................................................................................................................................. 17 " .................................................................................... 18 " .......................................................................................... 19 ...................................................................................................... 20 ................................................................................................. 20 ................................................................ 21 ............................................................................... 21 ....................................................... 23 ..................................................... 24 ................................................................................................................ 25 ........................................ 26 .................................................................. 26 .......................................................................... 27 ............................................................ 29 ........................................................................ 30 ..................................................................... 30 ................................................................................ 32 ....................................................................................................... 36 .......................................................... 36 ................................................... 39 ....................................................................................................... 40 ....................... 40 ................................................................................................................ 41 ........................................................................................................................ 52 ............... 46
iv
Hib
Haemophilus influenzae ± Calmette – Guérin
b ±
v
HbeAg – IgM HBc –
IgM FRUH
Hbc – HBs –
core
±
IgG HBs
± ± HbsAg) – ± ± ±
vi
WHO/V&B/01.31
1
2.1.
2.2.
2
100
80
60
40
20
%
0 1-6 7-12 1-4
2.3.
• • • •
±
[+%V$J@
WHO/V&B/01.31
3
+EH$J
.
± e [+EH$J@
±
HBs-Ag.
4
2.4. +%V$J +%V$J •
• •
( ( ( , , .. . . . -
HBsAg ≥8%) HBsAg 2%-7%) HBsAg <2%)
M.KANE/WHO
-
,
WHO/V&B/01.31
5
• • • 3.1
+%V$J
+%V$J
6
3.2
+%V$J
+%V$J
UnijectTM
•
•
WHO/V&B/01.31
7
•
3.3
8
• +%V$J HBs-Ag, +%V$J
•
4.1 Hib): +LE
Hib: +LE
• •
+LE
•
4.2 +%V
HBs-Ag (
WHO/V&B/01.31
9
4.3 4.4
+%V$J
4.5
81,-(&7TM).
+%V$J
+%V$J 4.6 Hib
10
± • 6.8). • • •
>:+29 %@
•
•
• •
±
+LE
+LE
WHO/V&B/01.31
11
4.7 0 0 +%V$J ± +LE ±0 +LE 0
0
±0
0
• • Galazka A, Milstien J, Zaffran M. Thermostability of vaccines (WHO/GPV/98.07). Proper handling and reconstitution of vaccines avoids programme errors. Vaccines and Biologicals Update, 2000, 34: 1-4.
4.8 4.9
12
• • • • • • • • • • • 4.10
4.11
WHO/V&B/01.31
13
I ** † ††
0 1 2 3 4
† † †
II
III †† †† ††
,
± III).
±
II
•
,,
,,,
•
14
•
•
4.12 4.13 ± 0 ±
±
•
Supplementary information on vaccine safety. Part 2: Background rates of adverse events following immunization (WHO/V&B/00.36).
WHO/V&B/01.31
15
5.1
"
• • • • •
•
16
•
•
"
5.2
5.3 "
WHO/V&B/01.31
17
• • • • • • • 5.4 "
81,-(&7TM);
•
Guidelines for estimating costs of introducing new vaccines into the national immunization system (WHO/V&B/ Estimating costs for budgeting and cost-effectiveness analysis related to new vaccines introduction).
18
5.5
"
• • •
WHO/V&B/01.31
19
6.1
20
• • • Procurement of vaccines for public sector programmes – a reference manual (WHO/V&B/99.12). Guidelines for the international procurement of vaccines and sera (WHO/VSQ/98.05). Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies (WHO/VSQ/97.06).
6.2 • © • • © • 6.3 • • Guidelines on international packaging and shipping of vaccines for the EPI (WHO/EPI/CCIS/81.04 REV.5). ª © ª ±0 :
ª;
WHO/V&B/01.31
21
• • +LE • 9,7-14,9 Uniject ) † ‡ ¶ ‡ TM †
3
4,8 41,2 9,7 3,2 -
3 3
3
3,0 8,2 3,0 -
24,6 9,7
+LE
¶
-
+LE
Hib.
• •
22
:+29$0Vaccine Volume Calculator).
0
:+2(3,/+,6
• •
• • • • 6.4
Safe vaccine handling, cold chain and immunizations. A manual for the Newly Independent States (WHO/EPI/LHIS/98.02). Immunization in practice. Module 3: The cold chain (WHO/TRAM/98.01-11 REV.1). Temperature monitors for vaccines and the cold chain (WHO/V&B/99.15). Product Information Sheets, 2000 edition (WHO/V&B/00.13).
WHO/V&B/01.31
23
• • 6.5
(1000 – 750)/1000 = 0,25 = 25%
• • • • •
24
• •
• •
Quality of the cold chain: WHO-UNICEF policy statement on the use of vaccine vial monitors in immunization services (WHO/V&B/99.18). WHO policy statement: the use of opened multidose vials of vaccine in subsequent immunization sessions (WHO/V&B/00.09).
6.6
:+29 %
• • • ± 0
990
• •
• • +LE
990 +LE
WHO/V&B/01.31
25
6.7 •
+LE
•
• • • • • •
Immunization in practice. Module 4: Ensuring safe injections (WHO/EPI/TRAM/98.04). Immunization in practice. Module 5: Organizing immunization sessions (WHO/EPI/TRAM/98.05).
6.8
26
(WHO/V&B/99.25);
:+2+4
http://www.injectionsafety.org/html/resources.html. • • • • • •
Report of the first meeting of the Steering Committee on Immunization Safety (WHO/V&B/00.17). WHO-recommended policy: safety of injections in immunization programmes (WHO/EPI/LHIS/96.05 Rev.1). Immunization in practice. Module 4: Ensuring safe injections (WHO/TRAM/98.01-11). Unsafe injection practices and transmission of bloodborne pathogens (WHO/DCT/99.1). Aide-memoire for a national strategy for the safe and appropriate use of injections (available at the SIGN Internet site: http://www.injectionsafety.org). Toolbox to assess and evaluate injection practices (available at the SIGN Internet site: http://www.injectionsafety.org).
6.9
WHO/V&B/01.31
27
,
,,
,,,
:+2(3,75$0
% %@ ©
ª
> % ±
>
±
@
28
• • • • • • • • •
WHO-recommended standards for surveillance of selected vaccine-preventable diseases (WHO/EPI/GEN/98.01 Rev. 1). Information for action - developing a computer-based information system for the surveillance of EPI and other diseases (IFA manual) (WHO/EPI/GEN/98.15). WHO vaccine-preventable diseases monitoring system: 2000 global summary (WHO/V&B/00.32). Immunization in practice. Module (WHO/EPI/TRAM/98.01-11 REV.1). 11: Monitoring immunization coverage
EPI coverage survey (WHO/EPI/MLM/91.10). Facilitator guide for the EPI coverage survey (WHO/EPI/MLM/91.11). Imaginative ways of raising immunization coverage (EPI update 32, November 1997). Monitoring immunization (WHO/VRD/TRAM/96.01). services using the lot quality technique
Monitoring immunization services using the lot quality technique – answer sheets (WHO/VRD/TRAM/96.01, Suppl. 1).
6.10 • • • Supplementary information on vaccine safety. Part 1: Field issues (WHO/V&B/00.24). Supplementary information on vaccine safety. Part 2: Background rates of adverse events following immunization (WHO/V&B/00.36). Surveillance of adverse events following immunization: field guide for managers of immunization programmes (WHO/EPI/TRAM/93.02 REV.1).
WHO/V&B/01.31
29
6.11
• • • • • • • • • • • 6.12
30
• • • • • • • • • • • •
WHO/V&B/01.31
31
• • • •
• • • • •
• •
Guidelines for planning training activities for immunization and disease control activities (WHO/EPI/TRAM/95.02). Training evaluation: a guide to the evaluation of training courses on immunization and other disease control activities (WHO/EPI/TRAM/95.03).
6.13
32
• • • • • • • • • • • • • • • • • •
WHO/V&B/01.31
33
•
Advocacy: a practical guide with polio eradication as a case study (WHO/V&B/99.20).
• • • • • • •
• •
•
Immunization in practice. Module 10: Communicating with parents and involving communities (WHO/EPI/TRAM/98.01-11 REV.1).
34
•
Supplementary information on vaccine safety. Part 1: Field issues (WHO/V&B/00.36).
WHO/V&B/01.31
35
7.1
+EV$J ,J0 +%V$J + FRUH IgM +%F +%F
•
• •
•
+%V$J +%V • IgM
FRUH V$J
36
• • Protocol for assessing prevalence of hepatitis B infection in antenatal patients (WHO/EPI/GEN/90.6). The United States National Library of (http://www.nlm.nih.gov/databases/freemedl.html). • Medicine MEDLINE database
+ FRUH ,J0
IgM
HBsAg, IgM +$9
WHO/V&B/01.31
37
IgM • •
IgM + FRUH IgM + FRUH +$9
V$J
•
http://www.ingectionsafety.org.
• •
38
7.2
268 364 544 675 2519 200 435 4791 424 1-10 3-4 2 9 4 3-4 7-8 1-8 7-10
96% 82% 37% 100% >90% 94% 87% 85% 73% 16 12 10 6,2 9 7 6,7 10 0.0 1,1 2,9 0,6 1,9 0,5 0,5 0,3 1,1
WHO/V&B/01.31
39
8.1
Uniject TM
40
1. Kane MA. Global status of hepatitis B immunization. Lancet, 1996, 348: 696. 2. Expanded Programme on Immunization. Global Advisory Group – Part I. Weekly Epidemiological Record, 1992, 67: 11í 3. Margolis HS et al. Prevention of hepatitis B virus transmission by immunization: an economic analysis of current recommendations. Journal of the American Medical Association, 1995, 274: 1201í 4. McMahon BJ et al. Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state. Journal of Infectious Diseases, 1985, 151: 599í 5. Margolis HS, Alter MJ, Hadler SC. Viral hepatitis. In: eds. Viral infections of humans. Epidemiology and control (Fourth Edition). New York, Plenum Publishing Corporation, 1997: 363í 6. Okada K et al. e antigen and anti-e in the serum of asymptomatic carrier mothers as indicators of positive and negative transmission of hepatitis B virus to their infants. New England Journal of Medicine, 1976, 294: 746í 7. Beasley RP et al. Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: final report of a randomized doubleblind, placebo-controlled trial. Hepatology, 1983, 3: 135í 8. Wong VC et al. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin. Double-blind randomised placebo-controlled study. Lancet, 1984, 1: 921í 9. Xu ZY et al. Prevention of perinatal acquisition of hepatitis B virus carriage using vaccine: preliminary report of a randomized, double-blind placebo-controlled and comparative trial. Pediatrics, 1985, 76: 713í. 10. Stevens CE et al. Yeast-recombinant hepatitis B vaccine. Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission. Journal of the American Medical Association, 1987, 257: 2612í6. 11. Poovorawan Y et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. Journal of the American Medical Association, 1989, 261: 3278í 12. Lee CY et al. The protective efficacy of recombinant hepatitis B vaccine in newborn infants of hepatitis B e antigen-positive-hepatitis B surface antigen carrier mothers. Pediatric Infectious Diseases Journal, 1991, 10: 299í 13. Beasley RP et al. Evidence against breast-feeding as a mechanism for vertical transmission of hepatitis B. Lancet, 1975, 2: 740í 14. Beasley RP et al. The e antigen and vertical transmission of hepatitis B surface antigen. American Journal of Epidemiology, 1977, 105: 94í WHO/V&B/01.31 41
15. Stevens CE et al. Vertical transmission of hepatitis B antigen in Taiwan. New England Journal of Medicine, 1975, 292: 771í 16. Barrett DH et al. Epidemiology of hepatitis B in two Alaska communities. American Journal of Epidemiology, 1977, 105: 118í 17. Leichtner AM et al. Horizontal non-parenteral spread of hepatitis B among children. Annals of Internal Medicine, 1981, 94: 346í 18. Whittle H et al. The pattern of childhood hepatitis B infection in two Gambian villages. Journal of Infectious Diseases, 1990, 161: 1112í 19. Beasley RP, Hwang LY. Postnatal infectivity of hepatitis B surface antigen-carrier mothers. Journal of Infectious Diseases, 1983, 147: 185í 20. Kashiwagi S et al. Transmission of hepatitis B virus among siblings. American Journal of Epidemiology, 1984, 120: 617í 21. Marinier E et al. Lack of perinatal transmission of hepatitis B virus infection in Senegal, West Africa. Journal of Pediatrics, 1985, 106: 843í 22. Franks AL et al. Hepatitis B infection among children born in the United States to southeast Asian refugees. New England Journal of Medicine, 1989, 321: 1301í 23. Davis LG, Weber DJ, Lemon SM. Horizontal transmission of hepatitis B virus. Lancet, 1989, 1: 889í 24. Botha JF et al. Hepatitis B virus carrier state in black children in Ovamboland: role of perinatal and horizontal infection. Lancet, 1984, 1: 1210í2. 25. Ko YC et al. Horizontal transmission of hepatitis B virus from siblings and intramuscular injection among preschool children in a familial cohort. American Journal of Epidemiology, 1991, 133: 1015í 26. Craxi A et al. Transmission of hepatitis B and hepatitis delta viruses in the households of chronic hepatitis B surface antigen carriers: a regression analysis of indicators of risk. American Journal of Epidemiology, 1991, 134: 641í 27. Hurie MB, Mast EE, Davis JP. Horizontal transmission of hepatitis B virus infection to United States-born children of Hmong refugees. Pediatrics, 1992, 89: 269í 28. Pon EW et al. Hepatitis B virus infection in Honolulu students. Pediatrics, 1993, 92: 574í 29. Mahoney FJ et al. Continuing risk for hepatitis B virus transmission among children born in the United States to southeast Asian children in Louisiana. Pediatrics, 1995, 95: 1113í 30. Van Damme P et al. Horizontal transmission of hepatitis B virus. Lancet, 1995, 345: 27í 31. Martinson FE et al. Risk factors for horizontal transmission of hepatitis B virus in a rural district in Ghana. American Journal of Epidemiology, 1998, 147: 478í 32. Hayashi Jet al. Hepatitis B transmission in nursery schools. American Journal of Epidemiology, 1987, 125: 492í 33. Nigro G, Taliane G. Nursery-acquired asymptomatic B hepatitis. Lancet, 1989, 1: 1451í 34. Shapiro CN et al. Hepatitis B virus transmission between children in day care. Pediatric Infectious Diseases Journal, 1989, 8: 870í
42
35. Breuer B et al. Transmission of hepatitis B virus to classroom contacts of mentally retarded carriers. Journal of the American Medical Association, 1985, 254: 3190í 36. David E et al. Molecular evidence of transmission of hepatitis B in a day-care centre. Lancet, 1996, 347: 118í 37. Oleske J et al. Transmission of hepatitis B in a classroom setting. Journal of Pediatrics, 1980, 97: 770í 38. Cancio-Bello TP et al. An institutional outbreak of hepatitis B related to a human biting carrier. Journal of Infectious Diseases, 1982, 146: 652í 39. Scott RM et al. Experimental transmission of hepatitis B virus by semen and saliva. Journal of Infectious Diseases, 1980, 142: 67í 40. Macquatrie MB, Forghani B, Wolochow DA. Hepatitis B transmitted by a human bite. Journal of the American Medical Association, 1974, 230: 723í 41. Williams I et al. Hepatitis B virus transmission in an elementary school setting. Journal of the American Medical Association, 1997, 278: 2167í 42. Bond WW et al. Survival of hepatitis B virus after drying and storage for one week. Lancet, 1981, 1: 550í 43. Petersen NJ et al. HBsAg in saliva, impetigenous lesions and the environment in two remote Alaskan villages. Applied Environmental Microbiology, 1976, volume 32: 572í 44. Simonsen L et al. Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bulletin of the World Health Organization, 1999, 77: 789í 45. Kane A et al. Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bulletin of the World Health Organization, 1999, 77: 801í 46. Hutin YJF, Chen RT. Injection safety: a global challenge. Bulletin of the World Health Organization, 1999, 77: 787í 47. Alter MJ, Margolis HS. The emergence of hepatitis B as a sexually transmitted disease. Med Clin North America, 1990, 74: 1529í 48. Hsu HM et al. Seroepidemiologic survey for hepatitis B virus infection in Taiwan: the effect of hepatitis B mass immunization. Journal of Infectious Diseases, 1999, 179: 367í 49. Sutanto A et al. Home delivery of hepatitis B vaccine to newborns in Indonesia: outreach immunization with a pre-filled, single-use injection device. Bulletin of the World Health Organization, 1999, 77: 119í 50. Otto BF et al. At-birth immunization against hepatitis B using a novel pre-filled immunization device stored outside the cold chain. Vaccine, 2000, 18: 498í 51. Courseget P, Kane M. Overview of clinical studies in developing countries. In: Ellis RW, ed. Hepatitis B vaccines in clinical practice. New York, Marcel Dekker, 1993: 209í. 52. Greenberg DP et al. Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age. Pediatric Infectious Diseases Journal, 1996, 15: 590í.
WHO/V&B/01.31
43
53. DaVilla G et al. Anti-HBs responses in children vaccinated with different schedules of either plasma-derived or HBV DNA recombinant vaccine. Research in Virology, 1997, 148: 109í 54. Apinall S, Kocks DJ. Immunogenicity of a low-cost hepatitis B vaccine in the South African Expanded Programme on Immunization. South African Medical Journal, 1998, 88: 36í 55. Hadler SC, Margolis HS. Hepatitis B immunization: vaccine types, efficacy, and indications for immunization. In: Remington JS, Swartz MN, eds. Current topics in infectious diseases (Volume 12). Boston, Blackwell Scientific Publications, 1992: 282í 56. Andre FE, Zuckerman AJ. Review: protective efficacy of hepatitis B vaccine in neonates. Journal of Medical Virology, 1994, 44: 144í 57. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 1994, 43(No. RR-1): 14í 58. Melnick JL. Thermostability of poliovirus, measles, and hepatitis B vaccines. Vaccine Research, 1995, 4: 1í 59. Van Damme P et al. Heat stability of a recombinant DNA hepatitis B vaccine. Vaccine, 1992, 10: 366í 60. Harpaz R et al. Elimination of chronic hepatitis B virus infections: results of the Alaska immunization program. Journal of Infectious Diseases, 2000, 181: 413í 61. West DJ, Calandra GB. Vaccine induced immunologic memory for hepatitis B surface antigen: implications for policy on booster vaccination. Vaccine, 1996, 14: 1019í 62. European Consensus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis B immunity? Lancet, 2000, 355: 561í 63. Centers for Disease Control and Prevention. Hepatitis B virus. A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee. Morbidity and Mortality Weekly Report, 1991, 40(No. RR-13): 1í 64. Vaccine Safety Committee, Institute of Medicine. Hepatitis B Vaccines. In: Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington DC, National Academy Press, 1994: 211í 65. Ascherio A et al. Hepatitis B vaccination and the risk of multiple sclerosis. New England Journal of Medicine, 2001, 344: 327í 66. Confavreax C et al. Vaccinations and the risk of relapse in multiple sclerosis. New England Journal of Medicine, 2001, 344: 319í 67. Chang MH et al. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. New England Journal of Medicine, 1997, 336: 1855í 68. Mahoney F et al. Evaluation of a hepatitis B vaccination program on the prevalence of chronic HBV infection. Journal of Infectious Diseases, 1993, 167: 203í 69. Viviani S et al. Hepatitis B vaccination in infancy in the Gambia: protection against carriage at 9 years of age. Vaccine, 1999, 17: 2946í
44
70. Ruff TA et al. Lombock hepatitis B model immunization project: toward universal infant hepatitis B immunization in Indonesia. Journal of Infectious Diseases, 1995, 171: 290í 71. Moulia-Pelat JP et al. A 5-year immunization field trial against hepatitis B using a Chinese hamster ovary cell recombinant vaccine in French Polynesian newborns: results at 3 years. Vaccine, 1994, 12: 499í 72. Al-Faleh FZ et al. Seroepidemiology of hepatitis B virus infection in Saudi children 8 years after a mass hepatitis B vaccination programme. Journal of Infection, 1999, 38: 167í 73. Chen HL et al. Seroepidemiology of hepatitis B virus infection in children: Ten years of mass vaccination in Taiwan. Journal of the American Medical Association, 1996, 276: 906í
WHO/V&B/01.31
45
" ± • • • hepatitis B virus (HBV ± b (hemophilus influenza b (Hib
• • • • • • •
46
" ± " "
" • • • • " "
WHO/V&B/01.31
47
" ± " " " " • • • • Hib. " 48
" ± Hib,
"
±
"
WHO/V&B/01.31
49
" ± 0 "
• • • ± 0
990
• •
• •
VVM)
"
50
• 6.8). • • >WHO/V&B/99.25]).
•
"
WHO/V&B/01.31
51
" ± • • • " "
• • • • • • •
52
" • • • • " " " • • • " Hib "
WHO/V&B/01.31
53
" ±
"
54