Last updated: 29 November 2024

Terms of Reference

Full Terms of Reference in PDF format

The Working Group is established to prepare a SAGE review of new evidence and advice to WHO on the use of meningococcal vaccines in order to mitigate the public health impact of the disease, including to reduce the risk of epidemics and to prevent health emergencies. Specifically, this will include updating recommendations for the optimal use of meningococcal conjugate vaccines in the meningitis belt and globally; as well developing recommendations for the use of meningococcal B vaccines.

The Working Group will also prepare a SAGE review of the plan and advice to WHO on the global roadmap to defeat meningitis by 2030, focusing on bacterial meningitis and equitable and sustainable access to vaccines, diagnosis and treatment. In order to prepare for the review, the Working Group will provide technical advice and support to the WHO secretariat through reviews of:

• The essential evidence required for updating or developing policy recommendations for meningococcal vaccines, including on strategies for use of vaccines to respond to epidemics;
• The updated epidemiological data on meningococcal carriage, disease, mortality and epidemics, globally and in different regions and population groups;
• The evidence on the use of meningococcal vaccines, globally and in different regions and population groups, including in outbreak response settings, with a particular focus on protein based vaccines against group B meningococcus and conjugate vaccines against all other meningococci;
• The evidence on the safety, immunogenicity and efficacy of candidate vaccines, in various target age groups and using different schedules.
• The results from modelling studies on the impact of different vaccination strategies.
• The summary of the above data for presentation to SAGE and the draft recommendations for consideration by SAGE. These recommendations will be used to update the WHO position paper on meningococcal vaccines.
• The draft Defeating meningitis by 2030 global roadmap and the draft advice for consideration by SAGE.

Composition

SAGE Members

• Ziad Memish: Saudi Ministry of Health, Saudi Arabia (Chair of the WG)
  
• Kathleen Neuzil: Center for Vaccine Development and Global Health (CVD), University of Maryland School of Medicine, USA
  

Experts

• Ray Borrow: Public Health England, UK
• Dominique Caugant: Norwegian Institute of Public Health, Norway
• Matthew Coldiron: Epicentre, France
• Abdulrazaq Garba Habib: Bayero University Kano, Nigeria
  
• Judith Mueller: Ecole des Hautes Etudes en Santé Publique, France
• Rasmata Ouedraogo: Centre Hospitalier Pédiatrique Charles de Gaulle, Burkina Faso
• Marco Sáfadi: Santa Casa de São Paulo School of Medical Sciences, Brazil
• Manish Sadarangani: University of British Columbia and British Columbia Children’s Hospital, Canada
• David Stephens: Emory University School of Medicine, USA
• Caroline Trotter: University of Cambridge, UK
• Ann von Gottberg: National Health Laboratory Service, South Africa
• Shao Zhujun: Chinese Center for Disease Control and Prevention, China

WHO secretariat

• Marie-Pierre Preziosi

Declarations of Interest

All members completed a declaration of interests form. Two SAGE member and seven 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:

SAGE members

Kathy Neuzil

• Serves as a member of the Board of Directors for the US National Foundation of Infectious Diseases. This interest was perceived as non-personal, non-specific and financially insignificant*.
• Serves as co-investigator on an NIH contract for a Vaccine and Treatment Evaluation Unit. As part of this contract, she is principal investigator for 3 studies: A trial of Tdap among pregnant women in Mali, clinical studies of H7N9 influenza vaccines among U.S. adults, and clinical study of H5N8 vaccine among U.S. adults. This interest was perceived as non-personal, non-specific and financially significant*.
• Serves as principal investigator for the Bill and Melinda Gates Foundation-funded Typhoid Vaccine Acceleration Consortium (2016-2021), which includes clinical studies of Bharat Biotech, India Typbar-TCV. This interest was perceived as non-personal, non-specific and financially significant*.
• Served as the IDSA liaison representation to the U.S. CDC Advisory Committee on Immunization Practices from 2010-December 31, 2018. This interest was perceived as non-personal, non-specific and financially insignificant*.
• Served as a co-investigator on a study of polyvalent meningococcal vaccine manufactured by Serum Institute of India, Ltd. (SIIL) in 2017 and 2018. This interest was perceived as non-personal, non-specific and financially significant*.
• Her institution receives research support for the following studies. These interests were perceived as non-personal, non-specific and financially significant*.
• A grant award from Nosocomial Vaccine Company for development of novel vaccines for multidrug-resistant gram-negative bacteria and for production and purification of Staphylococcus aureus type 5 and 8 capsule polysaccharides.
• Safety and reactogenicity of HTNV, PUUV, and combination HTNV/PUUV DNA vaccine from Geneva Foundation
• Phase 3A study of human rotavirus vaccine vaccine in healthy infants 6-12 weeks of age (ROTA-090) from GSK.
• Double-Blind, Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety, Tolerability, Efficacy, and Immunogenicity of a 2-Dose and 3-Dose Regimen of V160, Human Cytomegalovirus (HCMC) Vaccine in Healthy Seronegative Adolescent and Adult Women 16-35 Years of Age funded by Merck.
• A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children > 6 to < 72 Months of Age funded by ICON clinical Research, and ended in 11/16.
• Her institution received research support for the following studies:
• A grant from Bill and Melinda Gates Foundation to study influenza vaccine in pregnant women in Mali. (grant ended 2017).

These interests were perceived as non-personal, non-specific and financially significant*.

• Her institution received research support for a phase 2 safety and immunogenicity study of GSK recombinant chimpanzee adenovirus Ebola vaccine (grant ended 2/2017). This interest was perceived as non-personal, specific and financially significant*.
• Her institution receives research support for a study on safety and immunogenicity of GSKs' Rabies SAM (CNE) vaccine (GSK3903133A) in healthy adults (funded by GSK). This interest was perceived as non-personal, specific and financially significant*.

Peter McIntyre

• Serves on the Data and Safety Monitoring Board (DSMB) for Novovax Covid-19 Phase 1 trial. This interest was perceived as personal, non-specific and financially insignificant*.
  

Experts

Abdulrazaq Garba Habib

• Served until 2017 as consultant on meningococcal and pneumococcal vaccination at mass gatherings especially Hajj pilgrimage for Pfizer (Nigeria). This interest was assessed as personal, specific and financially insignificant*.

Judith Mueller

• Received until 2017 research support from the Meningitis Research Foundation. This interest was assessed as non-personal, specific and financially significant*.
• Serves as a member of the French Commission Technique des Vaccinations. This interest was assessed as personal, non-specific and financially insignificant*.

Marco Sáfadi

• Received support from Sanofi-Pasteur to present on “International Recommendations for MenACWY Vaccination” and “Mass Gatherings and Outbreak Preparedness” in an expert meeting in Seoul, Korea in 2017, an served on the Advisory Board for Meningococcal conjugate vaccines in Sao Paulo supported by Sanofi-Pasteur in 2018. These interests were assessed as personal, specific and financially insignificant*
• Served on the Advisory Board for Advisory Board for a pentavalent ABCWY Meningococcal Vaccine in 2017 (Amsterdam) and 2018 (London) and on the Advisory Board for Meningococcal Serogroup B Vaccine vaccines meeting in London in 2017 (London), and presented on Meningococcal Disease epidemiology at a company session at the ESPID congress in Malmoe, Sweden supported by Pfizer. These interests were assessed as personal, specific and financially insignificant in 2017 and financially significant in 2018*
• His institution has received research support from Pfizer from 2014- 2018 to study the epidemiology of serogroup B meningococcal disease in Brazil. This interest was assessed as non-personal, specific and financially significant*.

Manish Sadarangani

• Serves as principal investigator on long term memory responses to HPV vaccination following 2 vs. 3 doses of HPV-9 vaccine supported by Merck. This interest was assessed as non-personal, non- specific and financially significant*.
• Serves as co-investigator on a Phase 3 Double-Blind Randomized Controlled Study to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-BVac™ to a Three-dose Regimen of Engerix-B® in Adults supported by VBI Vaccines. This interest was assessed as non-personal, non-specific and financially significant*.
• Received grants from the Bill and Melinda Gates Foundation, Seqirus and Sanofi Pasteur on 5th International Neonatal and Maternal Immunization Symposium. This interest was assessed as non-personal, non-specific and financially significant*.
• Served as co-investigator on a phase 1, randomized, observer-blind, placebo-controlled, study to evaluate cytomegalovirus vaccine (VBI-1501) in healthy adults supported by VBI Vaccines (until April 2019). This interest was assessed as non-personal, non- specific and financially significant*.
• Served as co-investigator on a phase 1/2 randomized, observer-blind, controlled, multi-center, dose-escalation study to evaluate ChAd155-RSV (GSK3389245A) in RSV-seropositive infants aged 12 to 17 months supported by GSK (until March 2019). This interest was assessed as non-personal, non- specific and financially significant*.
• Serves or served as principal investigator or co-investigator on research project related to meningococcal disease and vaccinations supported by the Alberta Children’s Hospital Research Institute, Canadian Institutes of Health Research, Meningitis Research Foundation (until 2017) and the Academy of Medical Sciences (UK, until 2017). These interests were assessed as non-personal, specific and financially significant*.
• Serves as Principal Investigator or co-investigator in various research projects, including some related to Streptococcus pneumoniae and Haemophilus influenzae type a vaccination, supported by the National Institute for Health Research, the Canadian Paediatric Society, the BC Children's Hospital Research Institute, the Michel Smith Foundation, Cystic Fibrosis Canada, the BC immunization committee, The Ministère de la Santé et des Services sociaux Québec, the BC lung association, the Canadian Institutes of Health Research, the University of Northern British Columbia, Vancouver Coastal Health Authority, the University of British Columbia, and served until 2018 as Principal Investigator in projects supported by the European Society for Paediatric Infectious Disease and the Human Vaccines Project.
• These interests were assessed as non-personal, non-specific and financially significant*.

David Stephens

• Serves as a member of the US Advisory Committee on Immunization Practices (ACIP) until June 2019 and is Chair of the ACIP Meningococcal Vaccines working group. He also serves as an ad hoc member of the Vaccine and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration, and he’s member of the board of MenAfriNet. These interests were assessed to be personal, specific and financially insignificant. *

Caroline Trotter

• Served as a consultant for GSK to give input on their models for meningococcal disease and vaccination in 2018. Developed and delivered a workshop on meningococcal modelling for the Global Meningococcal Initiative supported by Sanofi Pasteur (2015). This interests was assessed to be personal, specific and financially insignificant.*

Ann von Gottberg

• Served as Principal Investigator on a study on “monitoring genotypes causing invasive pneumococcal disease in the era of conjugate vaccines, South Africa, 2015-2016” funded by Pfizer (2015-2017). She supervises a PhD student on a study “Meningococcal carriage among university students in South Africa” funded by Sanofi-Pasteur (until mid-2019). These interests were assessed to be non-personal, specific and financially significant.*
• She supervises a PhD student on a study “Incidence and transmission dynamics of Bordetella pertussis infection in the community in South Africa” funded by Sanofi-Pasteur (until end 2019). These interests were assessed to be non-personal, non-specific and financially significant.*
• Serves on the National Advisory Group on Immunization of South Africa and served as a member of the Global Meningococcal Initiative (until resignation in 2017). These interests were assessed to be personal, 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”.