Immunization, Vaccines and Biologicals

SAGE working group on polio (Established August 2008)

Terms of Reference

  • Prepare SAGE for the development of comprehensive policy guidance on the use of IPV in the post-eradication era in low and middle income settings, including by:
    • Reviewing long-term Polio Risks & Risk Management Strategies:
      reviewing the long-term risks associated with live polioviruses after wild polio transmission globally, and reviewing the range of strategies for mitigating those risks in low-income settings (e.g. coordinated OPV cessation, mOPV stockpiles and response mechanism).
    • Assessing Current & Future IPV Products:
      reviewing the existing range of IPV products, in terms of supply capacity, production cost, price, presentations, etc, and their appropriateness and suitability for low-income settings, particularly sub-Saharan Africa; and studying the IPV 'pipeline' and its implications for post-eradication IPV use in terms of potential new products (e.g. Sabin-IPV, adjuvanted-IPV, fractional dose IPV), production costs, and prices.
    • Establishing Potential IPV Policies & Implications:
      establishing the range of IPV vaccination schedule options that could be utilized in a post-eradication world, given the difference in polio immunization objectives and polio risks compared with a polio-endemic world; and identifying and characterizing the programmatic implications, economics and opportunity costs of those policy options, for both IPV stand-alone and combination formulations, in low-income settings and particularly sub-Saharan Africa;
    • Identifying and prioritizing knowledge gaps that should be addressed to facilitate SAGE decision-making on the role(s) and options for IPV use in the post-eradication era in low-income settings.
  • Propose key recommendations to SAGE for updating the 2003 position paper on IPV and consolidating it with other relevant documents (including the 2006 supplement to the IPV position paper) into one vaccine position paper on routine polio immunization covering both IPV and OPV and giving consideration to the ongoing polio eradication efforts.
  • Advise SAGE on technical guidance to WHO and the GPEI for the development and finalization of the overall polio eradication 'endgame strategy' to reduce long-term risks associated with OPV and to accelerate wild poliovirus eradication, including:
    • policy and programmatic options for the use of different OPV formulations and IPV delivery options, and
    • strategy and priorities in the related areas of outbreak response, surveillance, containment, risk assessment (esp. Vaccine Derived Polio Viruses - VDPVs), research and product development, and vaccine supply.

Composition

SAGE Members

  • Peter Figueroa (Chair of Working Group), University of the West Indies, Jamaica
  • Hyam Bashour, changed as of February 2013- retired from Damascus University, Syria (SAGE member until April 2011)
  • Zulfiqar Bhutta, The Aga Khan University, Pakistan (Joined the Working Group in March 2012)
  • Elizabeth Miller (SAGE member until January 2014), Health Protection Agency, United Kingdom

Experts

  • Walter Dowdle, Task Force for Child Health, USA
  • Nick Grassly, Imperial College, UK
  • Jacob John, Christian Medical College, India
  • Antoine Kabore, retired (formally of WHO/AFRO, Burkina Faso)
  • Francis Nkrumah, retired (formally of Noguchi Memorial Institute for Medical Research, University of Ghana Medical School, Ghana)
  • Walter Orenstein, Emory University, USA
  • Kimberley Thompson, Kids Risk Project, Harvard School of Public Health, USA

WHO Secretariat

  • Hiromasa Okayasu (replacement for Rudi Tangermann as of August 2013)
  • Bruce Aylward
  • Roland Sutter
  • Tracey Goodman
  • Philippe Duclos

DECLARATION OF INTERESTS FOR WHO EXPERTS

All members completed a declaration of interests. Only three members reported any relevant interests. It was concluded that all members could take part in full in all of the discussions. The reported relevant interests are summarized below:

Zulfiqar A Bhutta
  • Received in 2009 travel reimbursements from Sabin Institute for participation in meeting as a member of the Pneumococcal Awareness Council of Experts (PACE). This interest was assessed as personal, non-specific and financially insignificant*.
  • His department received in March 2011 a research grant from Novartis Global Health Institute on a Phase II trial of typhoid Vi conjugate vaccination. This interest was assessed as non-personal, non-specific and financially significant*.
Peter Figueroa
  • His unit receives a research grant from Merck to conduct a small clinical trial of an anti-retroviral drug on HIV for which he is the principal investigator. All the funds from this research grant go into expenses to cover the cost of the trial and he receives no payment for his contribution. This interest was assessed as non-personal, non-specific and financially significant*.
Walt Orenstein
  • His institution, Emory University, received between the years 2004 and 2009 a research support on Yellow Fever vaccine from sanofi pasteur. This interest was assessed as non-personal, non-specific and financially significant*.
  • His institution, Emory University, received in 2008 funds from GlaxoSmithKline for the Data and Safety Monitoring Board to evaluate safety and immunogenicity of pneumococcal vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
  • Received a small salary from the grant paid to Emory University by sanofi pasteur on Yellow Fever vaccine research in the year 2008. This interest was assessed as personal, non-specific and financially insignificant*.

* According to WHO's Guidelines for Declaration of Interests (WHO expert), an interest is considered "personal" if it generates financial or non-financial gain to the expert, such as consulting income or a patent. "Specificity" states whether the declared interest is a subject matter of the meeting or work to be undertaken. An interest has "financial significance" if the honoraria, consultancy fee or other received funding, including those received by expert's organization, from any single vaccine manufacturer or other vaccine-related company exceeds 10,000 USD in a calendar year. Likewise, a shareholding in any one vaccine manufacturer or other vaccine-related company in excess of 1,000 USD would also constitute a “significant shareholding”.

Last reviewed: 14 August 2013

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