1. Viral Hepatitis Prevention Board Geneve, March 14, 2003 Hepatitis B Vaccination: Impact of Safety Issues Israel Daniel Shouval Liver Unit Hadassah – Hebrew University Hospital Jerusalem

2. Israel: Population Profile* Population: 6,609,000 Population: 6,609,000 Jews and others 5,281,000, Arabs 1,227,000 Jews and others 5,281,000, Arabs 1,227,000 Annual live births (2001) 136,700 Annual live births (2001) 136,700 68% Jews, 26% Muslims, 2% Christian, 2% Druzes, 2% others. 68% Jews, 26% Muslims, 2% Christian, 2% Druzes, 2% others. GNP: $ 16,310 GNP: $ 16,310 Health Expenditure per capita - $1,500 Health Expenditure per capita - $1,500 *Ref: 53rd annual statistical report.

3. Infant Immunization Schedule – Israel* HAVMMRHibPolioDTPHBV + Day 1, m1 + + inj. + Month 2 + + 0, inj. + Month 4 ++0++ Month 6 ++ +0, inj. + Month 12 + M 18 + 24 + +0, inj. 6 y + 7 y +0+ 14 y *Compliance 95%

4. Post Immunization AE Report Form Local Redness swelling >5cm, pain. Nodule (cc) CellulitisAbcessLimpingGeneral Temperature >38°c Allergic reaction (Erythema, rash, urticaria ShockAnaphylaxis Pallor, cyanosis Sweling of lips, face Miscellaneous Dyspnea, Loss of consciousness Restlessness, Screaming >3h apathy, collapse. Convulsions, encephalitis, vomitting, diarrea, catarrh conjunctivitis, lymphadentitis, Orchitis, arthralgia, arthritis

5. Vaccine Coverage (%) in Israel for 2 years old babies (2000) Total Total Arabs/Dru zes Jews 939591DTP 939593Hib 939692IPV 939692OPV 959794MMR 989898HBV 899089HAV MOH, 2001 Source:

6. Adverse Events Surveillance Following Hepatitis B Immunization in Israel (I) Total Convulsi on Flaccidit y B.HoldTemp Local R. Crying5-113--1992 2-----2-1993 5--11211994 5--221-1995 5113---1996 11--515-1997 10-11-621998

7. Total Convulsio n Flaccidit y B.Hold**Temp Local R. Crying------1999 12--11642000 9---36-2001 101111512002 7324151235Total *In 11 year > 4.000.000 doses; ** 14/15 > 2nd dose Source: Dr. E Anis, MOH, Israel Adverse Events Surveillance Following Hepatitis B Immunization in Israel (II )*

8. Hepatitis B Vaccines: No of doses* Year1999200020012002No436,300432,422436,674453,500 * > 4,000,000 doses in 10 years.

9. Litigations Regarding Vaccine AEs NoYearNoYear 1199911995 3200011996 1200111997 3200221998 In past 30 years, 35 litigations concerning polio, 35 litigations concerning DTP, 1 concerning HBV.

10. Safety Issues and Immunization Patient bill of rightsPatient bill of rights How much information should be given to parents prior to immunization of a child (informed consent).How much information should be given to parents prior to immunization of a child (informed consent). The law does not enable forced vaccinationThe law does not enable forced vaccination National compensation law for vaccinees with serious AES (1989).National compensation law for vaccinees with serious AES (1989).

11. Arguments of Alternative Medicine and Antivaccine Advocates Against Universal Immunization on Day 1 of Life Unawareness of parents Unawareness of parents Informed consent is given at admission to maternity ward (stress) Informed consent is given at admission to maternity ward (stress) MOH takes advantage of parents fear of “neonatal jaundice” MOH takes advantage of parents fear of “neonatal jaundice” Vaccine contains Thimerosal and formaldehyde which maybe toxic to CNS Vaccine contains Thimerosal and formaldehyde which maybe toxic to CNS Immature immune system of the neonate Immature immune system of the neonate HBV is a sexual transmitted infection and therefore irrelevant to neonates. Vaccination start at birth for technical convenience reasons HBV is a sexual transmitted infection and therefore irrelevant to neonates. Vaccination start at birth for technical convenience reasons

12. Causes of delaying or refusal of vaccination Negligence of parents Negligence of parents Advocate of alternative medicine (“Natural immunization”, AEs) Advocate of alternative medicine (“Natural immunization”, AEs) Special groups (religious reasons) Special groups (religious reasons) Fear of AEs Fear of AEs