Last updated: 29 November 2024

Terms of Reference

Full Terms of Reference in PDF format

This Working Group will be requested to advise WHO and its Member States on the use of initially pre-licensed vaccines, followed by updates as additional information on product use becomes available. The timeliness of setting up this group will ensure a coordinated approach with the vaccine Research and Development (R&D) community, in order to accelerate timelines and maximize global efforts to make evidence-informed policy decisions for the best use of a vaccine against COVID-19. The ultimate goal of a vaccine against COVID-19 is to rapidly contain the pandemic, save lives, protect health care systems, and restore global economies.

Specifically the Working Group will be asked to:

• Provide continuous review of the available evidence on the progress of candidate vaccines against COVID-19, and provide regular updates to SAGE;
• Provide guidance for the development of prediction models to determine the optimal age groups and target populations for vaccine introduction and guide vaccine introduction for optimal impact, and contribute to updates of target product profiles of vaccines for outbreak and for endemic use;
• Prepare policy advice to SAGE on the accelerated use of vaccines (pre-licensure and post-licensure) to mitigate the public health impact of COVID-19, to possibly curtail the ongoing pandemic, as well as to prevent or reduce the risk of spread of disease in the future. This will include recommendations for early allocation of vaccines when vaccine supply is still limited.
• Provide guidance to ensure equitable access to vaccination, and guidance on the safety of vaccines when safety data from wider population use become available, in close collaboration with Global Advisory Committee on Vaccine Safety (GACVS).

Composition

SAGE Members

• Sonali Kochhar: University of Washington, USA (Chair of the Working Group)
• Saad Omer: Yale Institute for Global Health, USA
• Cristiana Toscano: Federal University of Goiás, Brazil

Experts

• Muhammed Afolabi: London School of Hygiene & Tropical Medicine, UK
• Celia Alpuche: Instituto Nacional de Salud Publica, Mexico
• David Durrheim: University of Newcastle, Australia
• Ruth Faden: Johns Hopkins Berman Institute of Bioethics, USA
• Stefan Flasche: London School of Hygiene & Tropical Medicine, UK
• Eusebio Macete: the Manhiça Health Research Centre, Mozambique
• Mary Ramsay: Public Health England, UK
• Peter Smith: London School of Hygiene & Tropical Medicine, UK
  
• Ruth Link-Gelles: U.S. Centers for Disease Control and Prevention, USA
• Yin Zundong: Chinese Center for Disease Control and Prevention, China

Ex Officio Members

• Klaus Cichutek: Paul-Ehrlich-Institut, Germany (Chair WHO Expert Committee on Biological Standardization (ECBS))
• Peter Figueroa: University of the West Indies, Jamaica (Chair PAHO Regional Immunization Technical Advisory Group)
• Christopher Morgan: Jhpiego, Australia (Chair Western Pacific Regional Immunization Technical Advisory Group)
• Helen Rees: University of the Witwatersrand, South Africa (Chair African Regional Immunization Technical Advisory Group)
• Ole Wichmann: Robert Koch Institute, Germany (Chair, European Technical Advisory Group of Experts (ETAGE))

WHO secretariat

• Annelies Wilder-Smith
• Joachim Hombach
• Melanie Marti

Rules of engagement

• Rules of Engagement
  pdf, 114kb

Declarations of Interest

All members completed a declaration of interests form. One SAGE member, four Ex Officio members and 6 Working Group members reported relevant interests. All interests were assessed not to constitute a conflict of interest. It was concluded that all members could take part in full in all of the proceedings of the Working Group. The reported relevant interests are summarized below:

Muhammed Afolabi

• He served as core member to the National Immunisation Technical Advisory Group, Sierra Leone Ministry of Health & Sanitation. This interest was perceived as non-personal, non-specific and financially insignificant*.
• He served on the Project Steering Committee, Malaria Vectored Vaccine Consortium (MVVC2). This interest was perceived as non-personal, non-specific and financially insignificant*.
• He serves as sub-investigator of several Ebola vaccine trials, funded by the Innovations for Medicines Initiative. This interest was perceived as personal, non-specific and financially insignificant*.
• He serves as Principal Investigator for a Malaria vaccine study co-administered with routine childhood vaccine in Gambia infants and neonates, and funded by EDCTP. This interest was perceived as personal, non-specific and financially insignificant*.
  

Ruth Faden

• Served as principal investigator on two related grants that focus on ethical issues in the inclusion of pregnant women in the development and deployment of epidemic vaccines (2016 through February 2020 funded by the Wellcome Trust. This interest was assessed as personal, non- specific, and financially significant*.
  

Christopher Morgan

• Serves as member of WHO, South East Asian Region Expert Advisory Panel on progress in Hepatitis B control. This interest was assessed as personal, non-specific, and financially insignificant*.
• Serves as member of Gavi Alliance, Vaccine Innovations Prioritization Strategy Steering Committee. This interest was assessed as personal, non-specific, and financially insignificant*.
• Serves as member of the Australian Regional Immunisation Alliance, Steering Committee. This interest was assessed as personal, non-specific, and financially insignificant*.
• Served as Chair of WHO, Immunization Practices Advisory Committee. This interest was assessed as personal, non-specific, and financially insignificant*.
• Serves as Senior Technical Advisor in immunization to Jhpiego. This interest was assessed as personal, non-specific, and financially significant*.
• Served as a principal research fellow at Burnet Institute with responsibility on development and research including immunization. This interest was assessed as personal, non-specific, and financially significant*.
• Served as Principal Investigator to study of frontline immunization services in PNG funded by Burnet Institute. This interest was assessed as non-personal, non-specific, and financially significant*.
• Served as Principal Investigator to Community engagement for immunization in Myanmar funded by BMGF. This interest was assessed as non-personal, non-specific, and financially significant*.

Saad Omer

• Serves on the National Academies of Sciences, Engineering and Medicine Committee on Equitable Allocation of Vaccines for the Novel Coronavirus*. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on the Board of Trustees of the Sabin Vaccine Institute. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on the National Vaccine Advisory Committee (NVAC) Working Group for Vaccine Hesitancy. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on the Lancet Commission on Vaccines in the USA. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on WHO Global Advisory Committee on Vaccine Safety. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on WHO Group B Strep Value Proposition Technical Working Group. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves as principal investigator for Tdap study in Guatemala. The study is funded by Thrasher Research Fund. This interest was perceived as non-personal, non-specific and financially insignificant*.
• Serves as principal investigator for Hepatitis B Vaccine Induced Immunity in Neonates pilot study. The study is funded by NIH. This interest was perceived as non-personal, non-specific and financially insignificant*.
• Serves as supervisor-lead for P3-MumBubVax clinical trials. This interest was perceived as non-personal, non-specific and financially insignificant*.
• Serves as a consultant for the Bill & Melinda Gates Foundation. This interest was perceived as personal, non-specific and financially significant*.
• Served as a member of the National Vaccine Advisory Committee from 2014 to 2018. This interest was perceived as personal, non-specific and financially insignificant*.
• Served as a senior consultant for GAVI from 2016 to 2017. This interest was perceived as personal, non-specific and financially significant*.
• Serves as a consultant for FDA Best Program Through IBM. This interest was perceived as personal, non-specific and financially significant*.

Mary Ramsay

• Serves as medical advisor for the Meningitis Research Foundation and Meningitis Now. This interest was assessed as personal, non-specific, and financially insignificant*.
• Serves as expert advisor to the National Institute of Health and Care Excellence quality guidelines on immunisation. This interest was assessed as personal, non-specific, and financially insignificant*.
• Her institution is involved in a cohort study of MVA-BN Smallpox Vaccine. This interest was assessed as non-personal, non-specific, and financially insignificant*.
• Served on the a Steering Group for GSK for cluster randomized controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage. This interest was assessed as personal, non-specific, and financially insignificant*.
• Serves as co-investigator for a National Immunisation Schedule Evaluation Consortium. This interest was assessed as personal, non-specific, and financially significant*.
• Her institution is involved in a trial on iMAP2 – persistence of antibody in infants born to women receiving a pertussis-containing vaccine during pregnancy. This interest was assessed as personal, non-specific, and financially insignificant*.
• Her institution is involved in an Immunogenicity and reactogenicity of a reduced schedule of a four-component capsular group B meningococcal vaccine (4CMenB): a randomised controlled trial in infants. This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution is involved in a trial on Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose (1 + 1) compared with two primary doses and a booster (2 + 1) in UK infants: a multicentre. This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution is involved in National immunisation Schedule Evaluation Consortium (NISEC). N (PR-R17-0916-22001) Departmental collaboration with a consortium of paediatric centres on studies to support the UK immunisation schedule. This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution is involved in NIHR Policy Research Programme. Evidence to Policy pathway to Immunisation in China (EPIC). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution is involved in the NIHR Global Research Group. Departmental collaboration with the London School of Hygiene and Tropical Medicine (LSHTM), CDC China and Fudan University. 2017-2020. This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution is involved in a departmental collaboration with LSHTM undertaking applied research to support the UK vaccination programme, 2015-2020. This was renewed 2020-2025. This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution provides vaccine manufacturers with post-marketing surveillance reports (Pfizer- Meningococcal disease, Pneumococcal- Impact of PCV in England and Wales. GSK- Pneumococcal disease, Bexsero. MSD- Invasive Pneumococcal disease) which the companies are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. This interest was assessed as non-personal, non-specific, and financially significant*.

Peter Smith

• Serves as member of the Independent Data Monitoring Committee for Sanofi Pasteur’s dengue vaccine clinical trials. This interest was assessed as personal, specific, and financially significant*.
• Serves as member of the DSMB for Serum Institute of India clinical trials of polyvalent conjugate vaccine (NmCV-5). This interest was assessed as personal, specific, and financially insignificant*.
• Serves as member of IDMC for the Vaccitech, Oxford influenza vaccine trial. This interest was assessed as personal, specific, and financially insignificant*.
• Provides advice to Valneva on chikungunya vaccine development. This interest was assessed as personal, specific, and financially insignificant*.
• Provides advice to Takeda on a dengue vaccine trial. This interest was assessed as personal, specific, and financially significant*.
• Serves as member of the Beijing Institute of Biotechnology DSMB on a Ebola vaccine trial. This interest was assessed as personal, specific, and financially insignificant*.
• Serves as member of the CEPI Scientific Advisory Committee. This interest was assessed as personal, specific, and financially insignificant*.
• Serves as Chair of IDMC for phase IIb trial of SARS-Cov-2 self-amplifying RNA vaccine (COVAC) developed by Imperial College. This interest was assessed as personal, specific, and financially insignificant*.

Christiana Toscano

• Serves on the WHO WG on Pneumococcal Vaccines. This interest was perceived as personal, non-specific and financially insignificant*.
• Serves on the PAHO TAG. This interest was perceived as personal, non-specific and financially insignificant*.
• Her institution receives funding from PAHO to provide technical support to research Project on PCV Impact in Latin America. This interest was perceived as non-personal, non-specific and financially significant*.
• Her institution receives funding from WHO to provide technical support to develop manual to assess PCV impact using secondary data. This interest was perceived as non-personal, non-specific and financially significant*.
• Her institution receives funding from RD4 to support to Lusophone speaking countries transitioning from GAVI support participating in the LNCT, on capacity building activities supported by GAVI. This interest was perceived as non-personal, non-specific and financially significant*.

* 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”.