Immunization, Vaccines and Biologicals

SAGE Working Group on Ebola Vaccines and Vaccination (established November 2014)

Terms of Reference

The Strategic Advisory Group of Experts (SAGE) on Immunization Working Group is exceptionally established with an urgent program of work to facilitate a SAGE review of available evidence and advice to WHO on the potential post-licensure use of the Ebola vaccines in order to mitigate the public health impact of the disease and possibly curtail the ongoing epidemic, as well as to prevent or reduce the risk of spread of disease in the future. The Working Group will consult with the Task Force for Immunization for the African region to get their inputs into the operationalization of immunization delivery and consolidate the feedback into a report to SAGE with recommendations on potential strategies for the deployment of vaccines.

In order to facilitate the review, the Working Group will provide technical advice and support to the WHO secretariat by:

  • Reviewing the essential evidence required for making policy recommendations and on strategies for deployment of vaccines.
  • Reviewing the available epidemiological data to define the risk of disease and mortality in different population groups in order to allow prioritization of vaccination.
  • Reviewing the evidence, as it becomes available, on the safety, and efficacy of candidate vaccines, including the optimal vaccination schedules to be used for each vaccine.
  • Reviewing the data on the projected impact of different vaccination strategies generated by mathematical models.
  • Reviewing the synthesis of the above data for presentation to SAGE and in drafting recommendations for consideration by SAGE.
  • Reviewing the projections of vaccine supply to inform recommendations on the deployment of vaccines.

Composition

SAGE members

  • Rees, Helen (Co-Chair, Chair of the African Task Force on Immunization (TFI) Executive Director -Reproductive Health Research Unit, University of Witwatersrand, South Africa (SAGE member until August 2013);
  • Were, Fred (Co-Chair of the Working Group from March 2016); Executive Director - Professor, Department of Paediatrics and Child Health, University of Nairobi, Kenya
  • Tomori, Oyewale (Co-Chair of the Working Group until March 2016), Professor of Virology, Redeemer's University, Nigeria; (SAGE member until August 2015)
  • O’Brien, Kate; Professor, Department of International Health & Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, USA
  • Wiysonge, Charles; (Director, South African Cochrane Centre, South African Medical Research Council; and Professor of Epidemiology and Biostatistics, Stellenbosch University, South Africa. (SAGE member since August 2015)

Experts

  • Andrews, Nick; Deputy Head of Statistics Unit, Public Health England, UK.
  • Bonsu, George; Immunization program manager Ghana, Ghana.
  • Durrheim, David; Hunter New England Area Health Service and Professor of Public Health, Australia
  • Goodman, Jesse; Professor of Medicine, Georgetown University, USA (resigned from Working Group in January 2017)
  • Jemmy, Jean-Paul; Medical Coordinator of Operations, Médecins San Frontières, Belgium
  • Kelly, Ann; Department of Global Health & Social Medicine at King's College London, UK
  • Moodley, Keymanthri; Director, Centre for Medical Ethics and Law, Department of Medicine, Stellenbosch University, South Africa.
  • Ndack, Diop: Lecturer in Socio-Anthropology & Methodology of research in social science. University Cheikh Anta Diop, Dakar, Senegal
  • Ockenhouse, Chris; Director, Medical and Clinical Operations, Malaria Vaccine initiative, PATH, USA.
  • Velasco Muñoz, Cesar; Preventive Medicine and Epidemiology Unit, Hospital Clínic-Universitat de Barcelona-Barcelona Centre for International Health Research, Barcelona, Catalonia, Spain. / Public Health Capacity and Communication Unit, European Center for Disease Control, Sweden.

Ex-Officio members

  • Breiman, Robert; (Chair of WHO Immunization and vaccines related implementation research advisory committee (IVIR-AC))
  • K. Cichutek; (Chair of WHO Expert Committee on Biological Standardization (ECBS))
  • Morgan, Chris; (Chair of WHO Immunization Practices Advisory Committee (IPAC))
  • Pless, Robert; (Chair of WHO Global Advisory Committee on Vaccine Safety (GACVS))

WHO Secretariat

  • Focal point: Ana-Maria Henao-Restrepo (replaced Thomas Cherian as of March 2016).

DECLARATION OF INTERESTS

Five core members of the Working Group reported relevant interests. One of the four ex-officio members reported conflicts of interest. The reported relevant interests are summarized below. All interests were assessed not to constitute a conflict of interest in regard to serving on the Working Group.

Working Group members

Andrews, Nicolas
  • His institution charges Pfizer, on a cost recovery basis, for post marketing surveillance reports for invasive pneumococcal disease in order for them to comply with their license requirements. This interest was assessed as non-personal, non-specific and financially significant*.
  • His institution charges Baxter and GSK, on a cost recovery basis, for post marketing surveillance reports for meningococcal disease in order for them to comply with their license requirements. This interest was assessed as non-personal, non-specific and financially significant*.
Moodley, Keymanthri
  • Her institution currently receives a training grant from the National Institute of Health to support capacity development in Health Research Ethics in Southern Africa. This interest was assessed as non-personal, non-specific and financially significant*.
  • Her institution currently receives non-monetary Research Project Grant from the National Institute of Health on HIV cure. This interest was assessed as non-personal, non-specific and financially significant*.
Munoz Velasco, Cesar
  • Received travel grants from GSK and sanofi to attend scientific conferences. This interest was assessed as personal, non-specific and financially significant*.
  • Received travel grants from GSK to attend a clinical trial principal investigators coordination meeting. This interest was assessed as personal, non-specific and financially non-significant*.
O’Brien, Kate
  • Serves as technical expert consultant for Merck on pneumococcal vaccination. This interest was assessed as non-personal, non-specific and financially insignificant*.
  • Served as member of DSMB on malaria RTS,S vaccine funded by PATH-Malaria Vaccine Initiative. This ceased in 2014. This interest was assessed as non-personal, specific and financially significant*.
  • Received funding for travel costs for a GSK Grand Convergence Meeting in 2015. This interest was assessed as non-personal, non-specific and financially insignificant*.
  • Her institution1 currently receives research grants from GSK, BMGF, National Institutes on Health (NIH), and GAVI regarding pneumococcal, rotavirus vaccines, technical country support and decision making on pneumococcal/rotavirus vaccine, vaccine demand support, and/or pneumonia etiology. This interest was assessed as non-personal, non-specific and financially significant*.
Were, Fred
  • Serves on the safety monitoring committee for an evaluation of i.v. injection of vialled P falciparum sporozoites. The sporozoite product is developed by Sanaria. This interest was assessed as non-personal, non-specific and financially insignificant*.
  • Serves on the PATH advisory board for the whole cell pneumococcal vaccine from 2013. This interest was assessed as non-personal, non-specific and financially insignificant*.

Ex-officio members

Griffiths, Elwyn
  • Serves as a member of the Korea Ministry of Food and Drug Safety Special Advisory Board. This interest was assessed as personal, non-specific and financially insignificant*.
  • Serves as a member of the UK Commission on Human Medicines Expert Advisory Group on Clinical Trials, Biologicals and Vaccines. This interest was assessed as personal, non-specific and financially insignificant*.
  • Serves on the member of International Alliance for Biologicals (IABS). This interest was assessed as personal, non-specific and financially insignificant*.
  • Received an honorarium in 2013 for the preparation and chairing the Second Alternative Potency Assay Workshop for Inactivated Influenza Vaccine, organized by the US Department of Health and Human Services/BARDA, the NIBSC UK and the IFPMA. This interest was assessed as personal, non-specific and financially insignificant*.
  • Served in 2013 and 2014, as a member of a small drafting group contracted by BMGF to prepare a Target Product Profile for a bivalent Typhoid/ Paratyphoid conjugate vaccine. 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 updated: 17 March 2016