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

  • Yagob Al-Mazrou: Health Services Council, Saudi Arabia. (Chair of the Working Group from September 2015)
  • Ilesh Jani: National Institute for Health, Mozambique. (Member of the Working Group from October 2016)
  • Youngmee Jee: Korean Centre for Disease Control and Prevention, Republic of Korea. (Member of the Working Group from October 2016)

Experts

  • Elizabeth Miller: Public Health England, United Kingdom. (Chair of the Working Group until February 2014 and SAGE member until November 2013)
  • Jacob John: Christian Medical College, India
  • Jeffery Mphahlele: South African Medical Research Council, South Africa. (Member of the Working Group from October 2016)
  • Khalequzzaman Zaman: International Centre for Diarrhoeal Disease Research, Bangladesh. (Member of the Working Group from October 2016)
  • Kimberley Thompson: Harvard University, United States of America.
  • Nick Grassly: Imperial College, United Kingdom.
  • Peter Figueroa: University of the West Indies, Jamaica. (Chair of the Working Group until August 2015 and SAGE member until April 2015)
  • Walter Dowdle: Task Force for Child Health, United States of America.
  • Walter Orenstein: Emory University, United States of America.
  • Zulfiqar Bhutta: The Aga Khan University, Pakistan. (Member of the Working Group from Nov 2012 and SAGE member until April 2015)

WHO Secretariat

  • Philippe Duclos
  • Tracey Goodman
  • Hiromasa Okayasu (replacement for Rudi Tangermann as of August 2013)
  • Roland Sutter
  • Ann Ottosen (UNICEF Supply Division)

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*.
Ilesh Jani
  • Serves as a site principal investigator for a clinical trial evaluating the safety, tolerability and immunogenicity of two prime-boost regimens of the candidate prophylactic vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo funded by Janssen Vaccines & Prevention B.V., and the Joint Vaccine Acquisition Program (JVAP). This interest was assessed as non-personal, specific and financially significant*.
  • Serves as principal investigator for phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa funded by the US National Institutes of Health (NIH), the HIV Vaccine Trial Network (HVTN) and the U.S. Military HIV Research Program (MHRP). 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 5,000 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: 31 March 2017