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.
Since April 2022, a SAGE Working Group on smallpox and mpox (from now on referred as SAGE WG) has been established by the Secretariat as a resource to support WHO in the preparation of SAGE deliberations by reviewing the available scientific evidence on smallpox and mpox vaccines and providing evidence-based information and options for policy or strategic recommendations to be decided by SAGE. This led WHO to issue recommendations on the use of smallpox and mpox vaccines during a smallpox outbreak as well as guidance on mpox outbreak response. The smallpox recommendations were published in the 2023 SAGE meeting report[1] and a position paper on mpox vaccines was published in August 2024[2]
A global outbreak of mpox started in May 2022, followed by a decline of cases throughout 2023. However, the number of mpox cases has continued to rise in parts of Central Africa, where the disease is endemic, and a growing number of countries in the African region, outside of endemic areas, have also started reporting cases. Additionally, a new mpox virus Clade 1b has emerged in the region. As a result, the terms of reference for the smallpox and mpox vaccines SAGE working group, have been updated to focus specifically on mpox vaccines considering the evolving epidemiological situation, and additional members are requested to join the SAGE WG.
Updated terms of reference
In alignment with WHO’s 4-year Strategic Framework for enhancing prevention and control of mpox (2024-2027), published in May 2024[3] and the WHO’s emergency SPRP on mpox[4], the WG will review evidence, provide advice and draft recommendations for SAGE consideration in accordance with the SAGE process for evidence-review and development of recommendations.
The Working Group will:
- Review new data to inform potential updates to the current mpox vaccination recommendations on outbreak response. This data may include information on mpox epidemiology, seroprevalence, vaccine safety and effectiveness (including post-exposure vaccine effectiveness), modes of transmission, fractional dosing, and one dose vaccination, particularly in endemic settings.
- Review new data to inform a potential recommendation on the preventive use of mpox vaccines. This data may include information on mpox epidemiology, disease severity, immunogenicity, vaccine safety and effectiveness, and the duration of vaccine protection, particularly in children, infants and special populations.
- Identify potential gaps in evidence and additional research needs for a potential recommendation on preventive use of mpox vaccines.
- Review data and timelines for licensure and potential WHO prequalification of mpox vaccines currently in the pipeline.
Collective expertise needed in the Working Group
- Mpox epidemiology and surveillance, particularly in endemic areas in the African setting
- Mpox virology
- Immunogenicity, effectiveness, and safety of mpox vaccines
- Immunology
In the selection of the additional WG members, consideration shall be given to attaining an adequate distribution of technical expertise, geographical representation and gender balance, with a specific emphasis on the African region.
Proposals for nominations should be sent by email to sageexecsec@who.int with a Curriculum Vitae, indication of relevant expertise, and a completed declaration of interest form. Only complete applications/nominations received by 6 November 2024, will be considered.
Information on the purpose, structure and functioning of SAGE Working Groups is available at http://www.who.int/immunization/sage/SAGE_Working_Groups_general_information.pdf?ua=1
[2] Smallpox and mpox orthopoxviruses vaccine position paper
[3] Strategic framework for enhancing prevention and control of mpox- 2024-2027