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Viral Hepatitis Prevention BoardViral Hepatitis Prevention BoardGeneve, March 14, 2003Geneve, March 14, 2003
Hepatitis B Vaccination:Hepatitis B Vaccination:
Impact of Safety IssuesImpact of Safety IssuesIsraelIsrael
Daniel ShouvalDaniel ShouvalLiver UnitLiver Unit
Hadassah – Hebrew University HospitalHadassah – Hebrew University HospitalJerusalemJerusalem
Israel: Population ProfileIsrael: Population Profile**
• Population: 6,609,000Population: 6,609,000
• Jews and others 5,281,000, Arabs 1,227,000Jews and others 5,281,000, Arabs 1,227,000
• Annual live births (2001) 136,700Annual live births (2001) 136,700
• 68% Jews, 26% Muslims, 2% Christian, 68% Jews, 26% Muslims, 2% Christian, 2% Druzes, 2% others.2% Druzes, 2% others.
• GNP: $ 16,310GNP: $ 16,310
• Health Expenditure per capita - $1,500Health Expenditure per capita - $1,500
*Ref: 53rd annual statistical report.*Ref: 53rd annual statistical report.
Infant Immunization Schedule – IsraelInfant Immunization Schedule – Israel**HBVHBVDTPDTPPolioPolioHibHibMMRMMRHAVHAV
Day 1, Day 1, m1m1
++
Month 2Month 2+++ inj.+ inj.++Month 4Month 4+++ 0,+ 0, inj.inj.++Month 6Month 6+++++0+0++Month Month 1212
+++0, inj.+0, inj.++++
M 18 + M 18 + 2424
++
6 y6 y+0, inj.+0, inj.++7 y7 y++14 y14 y+++0+0
*Compliance 95%
Post Immunization AE Report FormPost Immunization AE Report FormLocalLocal
Redness swelling >5cm, pain.Redness swelling >5cm, pain.Nodule (cc)Nodule (cc)CellulitisCellulitisAbcessAbcessLimpingLimping
GeneralGeneralTemperature >38Temperature >38°c°cAllergic reaction (Erythema, Allergic reaction (Erythema, rash, urticariarash, urticaria
ShockShockAnaphylaxisAnaphylaxisPallor, cyanosisPallor, cyanosisSweling of lips, faceSweling of lips, face
MiscellaneousMiscellaneousDyspnea, Loss of Dyspnea, Loss of consciousnessconsciousnessRestlessness, Screaming >3hRestlessness, Screaming >3hapathy, collapse.apathy, collapse.Convulsions, encephalitis, Convulsions, encephalitis, vomitting, diarrea, catarrhvomitting, diarrea, catarrhconjunctivitis, conjunctivitis, lymphadentitis, Orchitis, lymphadentitis, Orchitis, arthralgia, arthritisarthralgia, arthritis
Vaccine Coverage (%) in Israel forVaccine Coverage (%) in Israel for 2 years old babies (2000) 2 years old babies (2000)
JewsJewsArabs/Arabs/DruzesDruzes
TotalTotal
DTPDTP919195959393HibHib939395959393IPVIPV929296969393OPVOPV929296969393MMRMMR949497979595HBVHBV989898989898HAVHAV898990908989Source: Source: MOH, 2001MOH, 2001
Adverse Events Surveillance Following Adverse Events Surveillance Following Hepatitis B Immunization in Israel (I)Hepatitis B Immunization in Israel (I)
CryingCryingLocal R.Local R.TempTempB.HoldB.HoldFlacciditFlaccidityy
ConvulsiConvulsionon
TotalTotal
19921992----331111--55
19931993--
22----------22
1994199411221111----55
19951995--112222----55
19961996------33111155
19971997--551155----1111
199819982266--1111--1010
CryingCryingLocal R.Local R.TempTempB.Hold**B.Hold**FlacciditFlaccidityy
ConvulsioConvulsionn
TotalTotal
19991999------------
2000200044661111----1212
20012001--6633------99
200220021155111111111010
TotalTotal35351212151544227373
*In 11 year > 4.000.000 doses; ** 14/15 > 2nd dose
Source: Dr. E Anis, MOH, Israel
Adverse Events Surveillance Following Hepatitis B Adverse Events Surveillance Following Hepatitis B
Immunization in Israel (IIImmunization in Israel (II))**
Hepatitis B Vaccines: No of dosesHepatitis B Vaccines: No of doses**
YearYear
19991999
20002000
20012001
20022002
NoNo
436,300436,300
432,422432,422
436,674436,674
453,500453,500
* > 4,000,000 doses in 10 years.
Litigations Regarding Vaccine AEsLitigations Regarding Vaccine AEs
YearYearNoNoYearYearNoNo
19951995111999199911
19961996112000200033
19971997112001200111
19981998222002200233
In past 30 years, 35 litigations concerning polio, 35 In past 30 years, 35 litigations concerning polio, 35 litigations concerning DTP, 1 concerning HBV.litigations concerning DTP, 1 concerning HBV.
Safety Issues and ImmunizationSafety Issues and Immunization
• Patient bill of rightsPatient bill of rights
• How much information should be given to How much information should be given to parents prior to immunization of a child parents prior to immunization of a child (informed consent).(informed consent).
• The law does not enable forced vaccinationThe law does not enable forced vaccination
• National compensation law for vaccinees with National compensation law for vaccinees with serious AES (1989).serious AES (1989).
Arguments of Alternative Medicine and Arguments of Alternative Medicine and Antivaccine Advocates Against Universal Antivaccine Advocates Against Universal
Immunization on Day 1 of LifeImmunization on Day 1 of Life• Unawareness of parentsUnawareness of parents
• Informed consent is given at admission to maternity Informed consent is given at admission to maternity ward (stress)ward (stress)
• MOH takes advantage of parents fear of “neonatal MOH takes advantage of parents fear of “neonatal jaundice”jaundice”
• Vaccine contains Thimerosal and formaldehyde which Vaccine contains Thimerosal and formaldehyde which maybe toxic to CNSmaybe toxic to CNS
• Immature immune system of the neonateImmature immune system of the neonate
• HBV is a sexual transmitted infection and therefore HBV is a sexual transmitted infection and therefore irrelevant to neonates. Vaccination start at birth for irrelevant to neonates. Vaccination start at birth for technical convenience reasonstechnical convenience reasons
Causes of delaying or refusal of Causes of delaying or refusal of vaccinationvaccination
• Negligence of parentsNegligence of parents
• Advocate of alternative medicine Advocate of alternative medicine (“Natural immunization”, AEs)(“Natural immunization”, AEs)
• Special groups (religious reasons)Special groups (religious reasons)
• Fear of AEsFear of AEs
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