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Viral Hepatitis Prevention Board Geneve, March 14, 2003

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. Israel: Population Profile*. Population: 6,609,000 Jews and others 5,281,000, Arabs 1,227,000

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Viral Hepatitis Prevention Board Geneve, March 14, 2003

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

  3. Infant Immunization Schedule – Israel* *Compliance 95%

  4. Post Immunization AE Report Form Local Redness swelling >5cm, pain. Nodule (cc) Cellulitis Abcess Limping General Temperature >38°c Allergic reaction (Erythema, rash, urticaria Shock Anaphylaxis 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)

  6. Adverse Events Surveillance Following Hepatitis B Immunization in Israel (I)

  7. Adverse Events Surveillance Following Hepatitis B Immunization in Israel (II)* *In 11 year > 4.000.000 doses; ** 14/15 > 2nd dose Source: Dr. E Anis, MOH, Israel

  8. Hepatitis B Vaccines: No of doses* Year 1999 2000 2001 2002 No 436,300 432,422 436,674 453,500 * > 4,000,000 doses in 10 years.

  9. Litigations Regarding Vaccine AEs In past 30 years, 35 litigations concerning polio, 35 litigations concerning DTP, 1 concerning HBV.

  10. Safety Issues and Immunization • Patient bill of rights • How much information should be given to parents prior to immunization of a child (informed consent). • The law does not enable forced vaccination • 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 • Informed consent is given at admission to maternity ward (stress) • MOH takes advantage of parents fear of “neonatal jaundice” • Vaccine contains Thimerosal and formaldehyde which maybe toxic to CNS • 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

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

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