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Status of UNEP Negotiations affecting vaccine preservative Thiomersal

Status of UNEP Negotiations affecting vaccine preservative Thiomersal. Julia Hill CSO SC Meeting Dhaka, Bangladesh 11/11/11 Julia.hill@geneva.msf.org. Overview. Background on Thiomersal Ongoing UNEP negotiations & possible effect on thiomersal Update from UNEP INC3 in Nairobi Next steps

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Status of UNEP Negotiations affecting vaccine preservative Thiomersal

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  1. Status of UNEP Negotiations affecting vaccine preservative Thiomersal Julia Hill CSO SC Meeting Dhaka, Bangladesh 11/11/11 Julia.hill@geneva.msf.org

  2. Overview • Background on Thiomersal • Ongoing UNEP negotiations & possible effect on thiomersal • Update from UNEP INC3 in Nairobi • Next steps • Further resources

  3. Thiomersal • WHO-approved vaccine preservative, prevents contamination of multi-dose vials • Used in multi-dose presentations of: DTP, DT, TT, HepB, Hib, influenza, Men A conjugate, (theoretically PCV) • NOT used in live vaccines: MMR, polio, yellow fever, BCG • Thiomersal-containing vaccines used in over 120 countries, averted >1,400,000 child deaths in 2010 • Contains ethyl mercury. The WHO, U.S. and European regulatory authorities have found no evidence that thiomersal’s use in vaccines poses a health threat

  4. UNEP Negotiations: legally binding instrument on the use of mercury • Goal: limit exposure to and effects of anthropogenic mercury releases in the interests of health and the environment • Negotiators typically sit in Ministries of Environment or Finance • Last week in Nairobi: 3rd Session of Intergovernmental Negotiating Committee (INC3) convened • Current draft lists thiomersal on list of potential products that could be banned • An outright ban would mean multi-dose vials of affected vaccines could no longer be produced by or sold to country signatories

  5. What would a ban on thiomersal likely mean in practical terms? • LIMITED ACCESS TO VACCINES! • Worst case scenario: Suppliers switch to single-dose vials of affected vaccines prices rise cold chain requirements increase suppliers may be unable to maintain current production volumes (prices rise more) some developing countries can’t afford cost or cold chain expansion, or vaccines are not available • Testing or developing other vaccine preservatives would require WHO to re-prequalify new multi-dose formulations (years-long process)

  6. INC3 Nairobi: Oct. 31-Nov. 4, 2011 • WHO does MoH outreach in INC3 run-up, provides technical advice at INC3 • Where do various actors stand? • Anti-ban: • WHO, GAVI, CSO SC (released statements) • USA, EU, Norway, Canada (flu vaccine) • China (traditional medicines containing mercury) • Brazil, Korea, Cuba, Mali, Togo, Madagascar, CAR, Kenya, Tanzania, Cote d’Ivoire, many others • Wavering/Uncertain/Need more information: • Nigeria (want to switch to non-mercury preservative) • AFRO (want phase-out of thiomersal over time) • Mexico, Honduras, Pakistan (need more information) • Pro-ban • Chile (autism activist), South Africa (anti-vaccine Env. Minister)—causing uncertainty amongst some African and Latin American reps • CoMed, SafeMinds (anti-thiomersal activists)

  7. INC3 Nairobi: Oct. 31-Nov. 4, 2011, cont. • Contact group set up to discuss “products and processes”; met twice at INC3 • Potential options for solutions: • Positive list (exemptions) • Negative list (prohibited) • Hybrid +/- : list prohibited products but allow for temporary exemption period • Voluntary by country—no regulation • Many countries want to move to mercury-free products, provided these alternatives are: • Economic • Technically feasible • Available without interruption in supply during transition • (Note: this is closest to the hybrid solution)

  8. Next Steps • Negotiation rounds will continue: INC4, 25-29 June 2012 • WHO actions: this week SAGE endorsed proposal for scientific meeting on thiomersal alternatives, and review of policy implications prior to INC4; need to develop country-level action plan with Regional Advisors • Before INC4, need to provide authoritative evidence to countries on: • Alternative preservatives (2 phenoxy-ethanol) • Economic, programmatic, manufacturing implications of moving to single-dose preservative-free vaccines • Call next week between WHO, PATH, CSOSC rep, others involved, to discuss next steps • CSO SC thoughts or suggestions for possible solutions, next steps? Lobbying capacity in key countries?

  9. Further Resources • UNEP INC3 texts: • http://www.unep.org/hazardoussubstances/Mercury/Negotiations/INC3/INC3MeetingDocuments/tabid/3487/Default.aspx • CSO Submissions to UNEP (including PATH submission CSO SC supported): • http://www.unep.org/hazardoussubstances/Mercury/Negotiations/INC2/Informationforcivilsociety/NGOSubmissionpage/tabid/29782/Default.aspx • Technical info from WHO: • http://www.who.int/immunization/newsroom/thiomersal_information_sheet/en/index.html • http://www.who.int/immunization/newsroom/thiomersal_questions_and_answers/en/index.html

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