Strategic Advisory Group of Experts on Immunization / Malaria Policy Advisory Group Working Group on Malaria Vaccines

The Strategic Advisory Group of Experts on Immunization (SAGE) / Malaria Policy Advisory Group (MPAG) Working Group on Malaria Vaccines is a WHO Advisory Group with up to 15 experts. The role of the working group is two-fold, supporting WHO in the:

(i) Preparation of SAGE and MPAG deliberations and background materials on malaria vaccines by reviewing the evidence, as it becomes available, and by providing evidence-based information and/or options for guidance or strategy recommendations. This SAGE/MPAG Working Group is tasked to work on specific issues related to malaria vaccines and address critical questions on behalf of SAGE and MPAG; and

(ii) Provision of technical advice and recommendations for the duration of the Malaria Vaccine Implementation Programme (MVIP) to WHO.

SAGE/MPAG members serve in their personal capacities, based on their scientific and technical knowledge and experience, as well as their commitment and willingness to volunteer the necessary time and effort.

(Terms of reference for this group, formerly the Programme Advisory Group, PAG, were expanded and updated as of 11 November 2022.)

    Terms of reference

    Full Terms of Reference in PDF format

    Background

    The Strategic Advisory Group of Experts (SAGE) on Immunization was established in 1999 to provide policy and strategy advice on vaccines and immunization to the Director-General of the World Health Organization (WHO). SAGE is the principal advisory group to WHO for vaccines and immunization. All vaccine-and immunization-related topics of public health relevance for which WHO requires strategic and policy advice need to be reviewed by SAGE.

    The Malaria Policy Advisory Group (MPAG) – formerly called Malaria Policy Advisory Committee – was established in 2011 to provide independent advice to WHO to enhance the control and elimination of malaria. An independent advisory group bringing together the world’s foremost experts on malaria, the MPAG provides strategic advice and technical input to WHO, and extends to all aspects of malaria control and elimination, as part of a transparent, responsive and credible process. The MPAG advises the WHO Director-General and the Global Malaria Programme (GMP) specifically on appropriate malaria policies and standards based on data from malaria programme implementation by Member States and malaria control partners as well as reviews of the best available evidence; engagement of WHO in malaria-related initiatives; major issues and challenges to achieving global malaria goals; and identification of priority activities to address identified challenges.

    This SAGE/MPAG Working Group on Malaria Vaccines (from now on referred as  SAGE/MPAG WG) is established by the Secretariat as a resource intended to support WHO in the preparation of SAGE and MPAG deliberations by reviewing and providing evidence-based information and options for policy or strategy recommendations to be decided by SAGE and MPAG. This SAGE/MPAG WG is tasked to work on specific issues and address critical questions on behalf of SAGE and MPAG, to prepare the background material for SAGE and MPAG.

    1. Functions

      2. The SAGE/MPAG WG will be expected to formulate critical questions, as outlined below, for which an in-depth review of evidence is needed to address its workplan. With the support of Secretariat, this Working Group will perform or coordinate, a systematic assessment of the evidence in accordance with the SAGE process for evidence–review and development of recommendations.

      In its capacity as an advisory body to WHO, the SAGE/MPAG WG shall have the following functions:


      1. (i) Preparation of SAGE and MPAG deliberations and background materials on malaria vaccines by reviewing the evidence, as it becomes available, and by providing evidence-based information and/or options for guidance or strategy recommendations. This SAGE/MPAG Working Group is tasked to work on specific issues related to malaria vaccines and address critical questions on behalf of SAGE and MPAG; and
      2. (ii) Provision of technical advice and recommendations for the duration of the Malaria Vaccine Implementation Programme (MVIP) to WHO. 

    2. Composition

      1. The SAGE/MPAG WG shall have up to 15 members, who shall serve in their personal capacities to represent the following disciplines: malaria vaccines, including public health and epidemiology, malaria in Africa, vaccine safety, implementation research, clinical trials, statistics, immunization programmes, vaccine policy and implementation. In the selection of SAGE/MPAG WG members, consideration shall be given to attaining an adequate distribution of technical expertise, geographical representation and gender balance. 
      2. Members of the SAGE/MPAG WG shall be selected and appointed by WHO following an open call for experts. Suitable individuals who expressed interest to past open calls for other advisory groups (such as SAGE and MPAG) may also be considered. The Chairperson, and Co-Chariperson’s functions include the following:

          3. -       to chair the meeting of the SAGE/MPAG WG;

          -       to liaise with the WHO Secretariat between meetings;

          -       to present SAGE/MPAG WG outcomes and recommendations to SAGE and MPAG, and represent the views of the SAGE/MPAG WG at relevant meetings.

          In appointing the Chairperson and Co-Chairperson, consideration shall be given to gender and geographical representation.

      3. Members of SAGE/MPAG WG shall be appointed to serve for a period of up to 3 years and shall be eligible for reappointment. Their appointment and/or designation as Chairperson and Co-Chairperson is terminated when the SAGE/MPAG WG is closed after completion of its mandate (see section I. Functions) and may be terminated at any time by WHO if WHO's interest so requires or, as otherwise specified in these terms of reference or letters of appointment. Where a member’s appointment is terminated, WHO may decide to appoint a replacement member.
      4. SAGE/MPAG  WG members must respect the impartiality and independence required of WHO. In performing their work, members may not seek or accept instructions from any Government or from any authority external to the Organization. They must be free of any real, potential or apparent conflicts of interest. To this end, proposed members/members shall be required to complete a declaration of interests form and their appointment, or continuation of their appointment, shall be subject to the evaluation of completed forms by the WHO Secretariat, determining that their participation would not give rise to a real, potential or apparent conflict of interest.
      5. Following a determination that a proposed member’s participation in the SAGE/MPAG  WG would not give rise to a real, potential or apparent conflict of interest, the proposed member will be sent a letter inviting them to be a member of the SAGE/MPAG WG. Their appointment to SAGE/MPAG WG is subject to WHO receiving the countersigned invitation letter and letter of agreement. Notwithstanding the requirement to complete the WHO declaration of interest form, SAGE/MPAG WG members have an ongoing obligation to inform the WHO of any interests real or perceived that may give raise to a real, potential or apparent conflict of interest.
      6. As contemplated in paragraph II.4 above, WHO may, from time to time, request SAGE/MPAG WG members to complete a new declaration of interest form. This may be before a SAGE/MPAG WG meeting or any other SAGE/MPAG WG-related activity or engagement, as decided by WHO. Where WHO has made such a request, the SAGE/MPAG  WG member’s participation in the SAGE/MPAG WG activity or engagement is subject to a determination that their participation would not give rise to a real, potential or apparent conflict of interest.
      7. Where a SAGE/MPAG  WG member is invited by WHO to travel to an in-person SAGE/MPAG  WG meeting, WHO shall, subject to any conflict of interest determination as set out in paragraph II.6 above, issue a letter of appointment as a temporary adviser and accompanying memorandum of agreement (together ‘Temporary Adviser Letter’). WHO shall not authorize travel by a SAGE/MPAG  WG member, until it receives a countersigned Temporary Adviser Letter.
      8. SAGE/MPAG WG members do not receive any remuneration from the Organization for any work related to the SAGE/MPAG WG. However, when attending in-person meetings at the invitation of WHO, their travel cost and per diem shall be covered by WHO in accordance with the applicable WHO rules and policies.

    3. Operation

      1. The SAGE/MPAG WG accomplishes most of its work virtually via video or teleconferences. One or more SAGE/MPAG WG meetings may be held in person (at WHO headquarters in Geneva or another location, as determined by WHO).

        2. SAGE/MPAG WG meetings may be held in open and/or closed session, as decided by the Chairperson and Co-Chairperson in consultation with WHO.

        • (a)   Open sessions: Open sessions shall be convened for the sole purpose of the exchange of non-confidential information and views, and may be attended by Observers (as defined in paragraph III.3 below).

        • (b)  Closed sessions: The sessions dealing with the formulation of recommendations and/or advice to WHO shall be restricted to the members of the SAGE/MPAG WG and essential WHO Secretariat staff.

      2. The quorum for SAGE/MPAG WG meetings shall be two thirds of the members.
      3. WHO may, at its sole discretion, invite external individuals from time to time to attend the open sessions of an advisory group, or parts thereof, as “observers”[1]. Observers may be invited either in their personal capacity, or as representatives from a governmental institution / intergovernmental organization, or from a non-State actor. WHO will request observers invited in their personal capacity to complete a confidentiality undertaking and a declaration of interests form prior to attending a session of the advisory group. Invitations to observers attending as representatives from non-State actors will be subject to WHO internal due diligence and risk assessment including conflict of interest considerations in accordance with the Framework for engagement with non-State actors (FENSA). Observers invited as representatives may also be requested to complete a confidentiality undertaking. Observers shall normally attend meetings of the SAGE/MPAG WG at their own expense and be responsible for making all arrangements in that regard.

        4. At the invitation of the Chairperson and Co-Chairperson, observers may be asked to present their personal views and/or the policies of their organization. Observers will not participate in the process of deliberation and drafting of recommendations of the SAGE/MPAG  WG.

      4. The SAGE/MPAG WG may decide to establish smaller working groups (sub-groups of SAGE/MPAG WG) to work on specific issues. Their deliberations shall take place via teleconference or video-conference. For these sub-groups, no quorum requirement will apply; the outcome of their deliberations will be submitted to the SAGE/MPAG  WG for review at one of its meetings.
      5. SAGE/MPAG WG members are expected to attend meetings. If a member misses two consecutive meetings, WHO may end his/her appointment as a member of the SAGE/MPAG  WG.
      6. All conclusions and recommendations from the SAGE/MPAG WG are submitted to WHO for consideration and are advisory to WHO, who retains full control over any subsequent decisions or actions regarding any proposals, policy issues or other matters considered and recommended by the SAGE/MPAG  WG. WHO uses the analysis and recommendations to inform policy development by SAGE and MPAG.
      7. SAGE/MPAG WG shall normally make recommendations by consensus. If, in exceptional circumstances, a consensus on a particular issue cannot be reached, minority opinions will be reflected in the meeting report.
      8. Active participation is expected from all SAGE/MPAG WG members, including in subgroups, teleconferences, and interaction over email. Members may, in advance of SAGE/MPAG WG meetings, be requested to review meeting documentation and to provide their views for consideration by the SAGE/MPAG  WG.
      9. WHO shall determine the modes of communication by SAGE/MPAG WG, including between WHO and SAGE/MPAG WG members, and the SAGE/MPAG WG members among themselves.
      10. SAGE/MPAG WG members shall not speak on behalf of, or represent, the SAGE/MPAG  WG or WHO to any third party.

    4. Secretariat

      WHO shall provide the secretariat for SAGE/MPAG WG, including necessary scientific, technical, administrative and other support. In this regard, the WHO Secretariat shall provide the members in advance of each meeting with the agenda, working documents and discussion papers. Distribution of the aforesaid documents to Observers will be determined by the WHO Secretariat.

    5. Information and documentation

      1. Information and documentation to which members may gain access in performing SAGE/MPAG WG-related activities shall be considered as confidential and proprietary to WHO and/or parties collaborating with WHO. In addition, by counter signing the letter of appointment and the accompanying terms and conditions referred to in section II(5) above, SAGE/MPAG  WG members undertake to abide by the confidentiality obligations contained therein and also confirm that any and all rights in the work performed by them in connection with, or as a result of their SAGE/MPAG WG-related activities shall be exclusively vested in WHO.
      2. SAGE/MPAG WG members and Observers shall not quote from, circulate or use SAGE/MPAG WG documents for any purpose other than in a manner consistent with their responsibilities under these Terms of Reference.
      3. WHO retains full control over the publication of the reports of SAGE/MPAG WG, including deciding whether or not to publish them.

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    Composition

    • Nick Andrews
    • Kwando Odei Antwi-Agyei
    • Graham Brown**
    • S. Patrick Kachur
    • Corine Karema
    • Kim Mulholland*
    • Eusebio Macete (Co-Chair)
    • Kathleen Neuzil*
    • Faith Osier
    • Regina Rabinovich
    • Esperança Sevene
    • Laurence Slutsker
    • Peter Smith (Chair)
    *SAGE members
    **MPAG Members

     

    Declaration of Interests

    All 13 working group members updated their declaration of interests in preparation of the 2025 malaria vaccines evidence review. A total of 12 members reported relevant interests. These interests are included below. All interests were assessed not to constitute a conflict of interest for the purposes of this review. It was concluded that all working group members could participate fully in the meeting and all advisory group discussions. This section will be updated as appropriate. 

    Nick Andrews

    • His agency receives income from Pfizer, GSK and Merck and Sanofi to produce surveillance reports for manufacturers on a cost-recovery basis related to pneumococcal and meningococcal disease surveillance reports. This interest was assessed as non-personal, non-specific and financially significant*
    • Research and publications funded by United Kingdom National Institute for Health Research. This interest is assessed as non-personal, non-specific and financially insignificant*.  
    • Has advised on statistical aspects of manuscripts and reports. This interest is assessed as personal, non-specific and financially insignificant*. 

    Kwando Odei Antwi-Agyei

    • No declarations of interest were shared.

    Graham Brown

    • Consulting – WHO/Global Malaria Programme contract to write the interim draft of the Executive Summary of Strategic Advisory Group on malaria eradication (SAGme) report (2019). This interest was assessed as personal, non-specific and financially significant*.
    • Knowledge declaration – The outcome of the meeting could benefit or adversely affect interests of declared close professional colleagues working in malaria research with interests in vaccines, diagnostic tests and anti-malaria drugs. This interest is assessed as personal, non-specific and financially insignificant. All knowledge obtained through MPAG functions is bound by the conditions outlined in the Confidentiality of Understanding signed by all MPAG members*.

    S. Patrick Kachur

    • Ongoing advisory roles since 2018 on the Zanzibar Malaria Elimination Advisory Committee and the Board of Directors of Medical Care Development, Inc. This interest is assessed as non-personal, non-specific and financially insignificant*.
    • Consultant with the Clinton Health Access Initiative until 2023 providing technical assistance for developing and completing malaria surveillance assessments in multiple countries. This interest is assessed as personal, non-specific and financially significant*.
    • Consultant with the Clinton Health Access Initiative until 2023 providing technical assistance for developing and completing malaria surveillance assessments in multiple countries. This interest is assessed as personal, non-specific and financially significant*.
    • Consultant with the Clinton Health Access Initiative until 2023 providing technical assistance for developing and completing malaria surveillance assessments in multiple countries. This interest is assessed as personal, non-specific and financially significant*.

    Corine Karema

    • Serves as a member on International Society of Pneumonia and Pneumococcal Diseases (ISPPD) board. This interest was perceived as personal, non-specific and financially insignificant*.
    • Served as a member until 2023 on the INLLEN board. This interest was perceived as personal, non-specific and financially insignificant*.

    Kim Mulholland

    • Served until 2022 as Novavax DSMB for COVID-19 vaccine trials in Australia and South Africa. This interest was perceived as non-personal, non-specific and financially insignificant*
    • Served until 2024 as principal investigator of a trial of reduced dose number schedules of Pneumosil in Viet Nam, funded by the Gates Foundation. This interest was assessed as non-personal, non-specific and financially significant*
    • Serves as co-principal investigator on a Human papillomavirus (HPV) vaccine trial in Viet Nam, funded by UKRI. This interest was assessed as non-personal, non-specific and financially significant*
    • Served until 2023 as principal investigator for a PCV introduction study in Mongolia funded by the Gavi. This interest was assessed as non-personal, non-specific, and financially significant*.
    • Serves as co-investigator on a study of the effectiveness of typhoid conjugate vaccine in Fiji, funded by Korea philanthropy. This interest was assessed as non-personal, non-specific and financially significant*.
    • Serves as principal investigator on a COVID-19 trial in Mongolia, Indonesia, Australia, funded by CEPI. This interest was assessed as non- personal, specific and financially significant*.
    • Served until 2025 as principal investigator on a study of HPV introduction evaluation in Ethiopia, funded by UK Research and Innovation (UKRI) and BMGF. This interest was assessed as non- personal, non-specific and financially significant*.

    Eusebio Macete

    • Serves as the Director General of the Farmacias de Moçambique (Empresa Farmácias de Moçambique, Sociedade Anónima). This interest was assessed as personal, non-specific, and financially significant*.
    • Serves a member of the of the Mozambican NAITAG (National Immunization Technical Advisory Group). This interest was perceived as non-personal, specific and financially insignificant*

    Kathleen Neuzil

    • Serves as a member of the Board of Directors and government liaison, National Foundation for Infectious Diseases. This interest was perceived as non-personal, non-specific and financially insignificant*.
    • Serves as a chair at Pfizer DSMB for influenza vaccine. This interest was perceived as non-personal, specific and financially significant*.
    • Served until 2021 as an investigator on a grant from University of Washington for a COVID-19 post-exposure prophylaxis study of hydroxychloroquine. This interest was perceived as non-personal, non-specific and financially significant*.
    • Served until 2022 as co-chair of the National Institutes of Health (NIH) COVID-19 Vaccine Prevention Network, which serves as the focal point for USG sponsored trials in COVID-19 vaccines and monoclonal antibodies. This Network is supported through an NIH grant for the leadership of the Vaccine Treatment and Evaluation Units. This interest was perceived as non-personal, specific and financially significant*.
    • Served until 2023 as principal investigator for the NIH funded NIH T32 Fellowship Training Program in Vaccinology. This interest was perceived as non-personal, non-specific and financially significant*.
    • Served until 2024 as principal investigator for NIH-funded Collaborative Influenza Vaccine Innovation Center (CIVICs) program. This interest was perceived as non-personal, specific and financially significant*.
    • Served until 2024 as principal investigator for the National Institute of Allergy and Infectious Diseases (NIAID) /NIH funded Advanced Development of a Multivalent Vaccine Candidate for Filovirus and Lassa Fever. This interest was perceived as non-personal, non-specific and financially significant*.
    • Served until 2024 as principal investigator for the BMGF-funded Typhoid Vaccine Acceleration Consortium (2016-2021 and extension 2021-2025), which includes clinical studies of Bharat Biotech, India Typbar-TCV. This interest was perceived as non-personal, non specific and financially significant*.
    • Served until 2024 as a principal investigator for the Vaccine Company, Inc. funded “A Phase 1, Open-label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of DCFHP-Alum, A Spike-Functionalized Ferritin Nanoparticle Vaccine Targeting COVID-19, Col-formulated with Aluminum Hydroxide Adjuvant, in Healthy Adults in the United States”. This interest was perceived as non-personal, specific and financially insignificant*.

    Faith Osier

    • Serves as the principal investigator for the Chanjo Hub at Imperial College London, related to blood stage malaria vaccines. This interest was perceived as personal, non-specific and financially significant*.
    • Receives research funding from multiple sources including the Wellcome Trust, the United Kingdom Research and Innovation (UKRI) and the Academy of Medical Sciences, UK. This interest was perceived as personal, non-specific and financially significant*.
    • Received funding from EDCTP and Alexander von Humboldt Foundation until 2024. This interest was perceived as personal, non-specific and financially significant*.

    Regina Rabinovich

    • Serves as an International Scholar and Director, Malaria Elimination Initiative at ISGlobal, U. Barcelona. This interest was perceived as personal, non-specific and financially significant*.
    • Receives funding through a multiyear grant from the Bill & Melinda Gates Foundation (BMGF) through ISGlobal to support malaria-related evidence evaluation, research gaps, project tracking, and resources. This interest was perceived as personal, non-specific and financially significant*.
    • Scholar with the Harvard TH Chan School of Public Health. It was just reapproved for this year. This interest was perceived as personal, non-specific and financially insignificant.

    Dr Esperança Sevene

    • Formerly a member of the MVIP Data Safety Monitoring Board until June 2025. This interest was perceived as non-personal, specific and financially insignificant*.

    Laurence Slutsker

    • Served as an independent consultant until March 2025 for WHO’s Department of Immunization, Vaccines, and Biologicals (IVB) prior to joining the Working Group. This interest was perceived as personal, specific and financially significant*.

    Peter Smith

    • Serves as Co-chair of DSMB for SARS-CoV-2 human challenge trials sponsored by Imperial College. This interest was assessed as personal, non-specific, and financially insignificant*.
    • Serves as member of SAC for Phase 3b trial of Pfizer maternal RSV vaccine in four African countries sponsored by Wits Health Consortium, University of the Witwatersrand. This interest was assessed as personal, non-specific, and financially insignificant*.
    • Serves as member of DSMB for Phase 1 and 2 trials of whole cell pneumococcal vaccine funded by Rochester General Hospital Research Institute. This interest was assessed as personal, non-specific, and financially insignificant*.
    • Serves as member of WHO SAGE Working Group on COVID-19 vaccines. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Serves as member of SAC for a European Union-funded project on the development of a Generalized Modules for Membrane Antigens (GMMA)-based vaccine against invasive non-typhoidal salmonellosis. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Serves as member of EDCTP/CEPI Oversight Committee for IAVI Phase IIb trial of Lassa Vaccine in West Africa (LEAP4WA). This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Serves as Chair of DSMB for a placebo-controlled Phase 2 trial to assess the safety and immunogenicity of a parenteral Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV) developed at the University of Maryland in collaboration with Bharat Biotech International, Hyderabad, India. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Served as member of the Independent Data Monitoring Committee (IDMC) for Sanofi Pasteur’s dengue vaccine clinical trials until 2024. This interest was assessed as personal, non-specific, and financially significant*.
    • Served as member of WHO working group to develop a roadmap for the global introduction of new TB vaccines intended for adults and adolescents until 2024. This interest was assessed as non-personal, non-specific, and non-financially insignificant*.
    • Provided advice to Takeda on a dengue vaccine trial until 2024. This interest was assessed as non-personal, non-specific, and financially significant*.
    • Provided advice to Valneva on chikungunya vaccine development until 2024. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Served as member of the CEPI SAC until 2023. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Served as Vice Chair of EDCTP Scientific Advisory Committee (SAC) until 2022. This interest was assessed as non-personal, specific, and financially insignificant*.
    • Served as member of DSMB for trials of Curevac mRNA SARS-CoV-2 vaccine (CVnCoV) until 2022. This interest was assessed as personal, non-specific, and financially significant*.
    • Served as member of WHO Committee to develop a framework for the allocation of limited supplies of malaria vaccines until 2022. This interest was assessed as non-personal, specific, and non-financially insignificant*.
    • Served as Chair of IDMC for phase IIb trial of SARS-Cov-2 self-amplifying RNA vaccine (COVAC) developed by Imperial College, London until 2021. This interest was assessed as personal, specific, and financially insignificant*. This interest was assessed as non-personal, non-specific, and financially insignificant*.
    • Served as member of WHO Product Development for Vaccines Advisory Committee until 2021. This interest was assessed as non-personal, specific, and non-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 US $5 000 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”. As per WHO assessment of conflicts of interests, “Institution” relates only to the expert’s research/or work unit, as subdivision of the department. Funding going to the SAGE member’s research unit needs to be declared.