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