Last updated: 23 February 2025

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

• Shabir Mahdi, Professor of Vaccinology at the University of the Witwatersrand, Johannesburg, South Africa (Co-chair of the Working Group).

Experts

• Helen Rees, Executive Director, Wits Reproductive Health and HIV Institute (Wits RHI), 22 Esselen St & Klein St, Hillbrow, Johannesburg, 2001, South Africa (Chair of the Working Group)
• Ezzeddine Mohsni, Global Health Development, Eastern Mediterranean Public Health Network, Tunisia
• Nick Andrews, Deputy Head of Statistics Unit, Public Health England, London United Kingdom of Great Britain & Northern Ireland
• George Bonsu, National Programme Manager, Expanded Programme on Immunization (EPI), Ghana Health Service, P. O. Box KB 493, Accra, Ghana
• Ndack Diop, Lecturer in Socio-Anthropology & Methodology of research in Social Science, University Cheikh Anta Diop, Dakar, Senegal
• David Durrheim, Professor of Public Health Medicine, University of Newcastle, Locked Bag 10, Wallsend NSW, Australia
• Jean-Paul Jemmy, Medical Coordinator of Operations, Médecins San Frontières, Brussels, Belgium
• Ann Kelly, Senior Lecturer in Global Health, Department of Global Health & Social Medicine at King's College London, The Strand, London WC2R 2LS, United Kingdom of Great Britain & Northern Ireland
• Keymanthri Moodley, Director, Centre for Medical Ethics and Law, Department of Medicine, Stellenbosch University, Cape Town 8000, South Africa
• Cesar Velasco Muñoz, Preventive Medicine and Epidemiology Unit, Hospital Clínic-Universitat de Barcelona-Barcelona Centre for International Health Research, Barcelona, Catalonia, Spain
• Chris Ockenhouse, Director, Medical and Clinical Operations, Malaria Vaccine initiative, PATH, 455 Massachusetts Avenue NW, Washington, DC 20001, United States of America
• Robert Pless, Medical Advisor, Vaccine Safety, Public Health Agency of Canada, 130 Colonnade Rd, PL6501A, Ottawa, Ontario K1A 0K9, Canada
• Oyewale Tomori, Professor of Virology, Redeemer's University, Redeemer's University, Gbongan - Oshogbo Rd, Ede, Nigeria
• Fred Were, Executive Director - Professor, Department of Paediatrics and Child Health, University of Nairobi, Nairobi, Kenya
  

Ex-Officio members (including but not always invited)

• Walt Orenstein (Chair - IVIR AC), Emory Global Health Institute, Emory University, 1599 Clifton Road, Suite 6.101, Atlanta, GA 30322, United States of America
• Klaus Cichutek, President, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany

Ex-WG members

• Goodman, Jesse; Professor of Medicine, Georgetown University, USA (resigned from Working Group in January 2017)
• O’Brien, Kate; Professor, Department of International Health & Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, USA (SAGE member until January 2019, resigned from the Working Group in January 2019)

WHO Secretariat

• Ana-Maria Henao-Restrepo (Focal point)

DECLARATION OF INTERESTS

Five core members of the Working Group reported relevant interests. 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.

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*.

Shabir Madhi

• Serves as a member of the International Vaccine Initiative Scientific Advisory Committee. This interest was assessed as personal, non-specific and financially insignificant*.
• Serves as a member of the BMGF Global Health Scientific Advisory Committee. This interest was assessed as personal, non-specific and financially significant*.
• Served as advisor to the Pfizer Group B streptococcal (GBS) vaccine program until 2017. This interest was assessed as personal, non-specific and financially insignificant*.
• Serves as a member of the DSMB of GSK on porcine-free rotavirus vaccine. This interest was assessed as personal, non-specific and financially insignificant*.
• Serves as a member of the DSMB of Janssen on inactivated polio vaccine. This interest was assessed as personal, non-specific and financially insignificant*.
• Serves as a member of the DSMB of CAPRISA on a HIV monoclonal antibody. This interest was assessed as personal, non-specific and financially insignificant*.
• His institution receives grants from Pfizer on a GBS vaccine clinical trial and GBS epidemiology study on correlate of protection. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received grants from Novartis and GSK support on GBS epidemiology until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives grants from BMGF on epidemiology studies of GBS and pneumococcus, and clinical trials on PCV. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received a grant from VPM /Serum Institute regarding a clinical trial on tuberculosis until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution received a grant from MedImmune regarding clinical trials on RSV monoclonal antibody until 2017. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives a grant from Novovax regarding a clinical trial on maternal RSV vaccine program. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution receives a grant from Mitsubishi regarding a clinical trial on rotavirus vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution will receive a grant from MSD in February 2019 regarding a clinical trial on monoclonal RSV antibody. 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*.

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*.

* 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”.