1. Vaccination and auto-immunity : reassessing evidence Marc GIRARD, MSc, MD 1 bd de la République 78000-Versailles (France) Vaccination, Infection & Automminunity: Myth & Reality (Lausanne, 26-28 October 2005)

2. Auto-immune hazards Individual toxicity (1 vaccine) Additive effect (  2 vaccines) Interactive effect (  2 vaccines) + +

3. “ADVERSE REACTIONS ENGERIX-B is generally well tolerated (…) In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children (…) All subjects were monitored for 4 days post-administration (…)”. Physician Desk Reference

4. “(…) Researchers analysed the US Vaccine Adverse Event Reporting System (VAERS) database for serious neurological symptoms (…) MHRA dismisses study findings (…) The MHRA notes that the authors failed to consider the limitations and biases inherent in VAERS data (…)”. MHRA: Study on safety of MMR vaccine by Geier and Geier - conclusions are not justified. Internet-Document, 22 May 2003.

5. “ (…) The Vaccine Adverse Event Reporting System (VAERS) in the US is a useful surveillance system for ensuring the safety of vaccines, according to researchers from the US FDA and Centres for Disease Control and Prevention (CDC) (…)” Morbidity-and-Mortality-Weekly-Report, vol. 52, page 1-26, 24 January 2003

6. “(…) Since tolcapone was marketed, there had been 10 reports of serious hepatic adverse reactions (…) The CPMP considered that the overall balance of risks and benefits of tolcapone was no longer favourable (…) Consequently, tolcapone was voluntarily withdrawn (…)” Current Problem in Pharmacovigilance (25 Feb 1999)

7. VaccineNumber of case reports prior to 19951983-2004 HBV42102 Measle or MMR2040 Tetanus or DTP1327 Haemophilus influenzae type b 47 Polio or DTP33 Published case reports on various vaccine hazards in REACTIONS database

8. Data of health insurance system (France)

12. “Dear Dr Girard On the basis of the advice I have received I have decided not to go ahead with your publication. X… Emeritus Professor of Science and Engineering Ethics”

13. Conclusions Vaccine R&D: the zero-level of EBM HBV: unusually toxic (esp. for a vaccine) A moral responsibility for each of us