Last updated:17 May 2023

Terms of Reference

In 2013, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization issued recommendations on the use of smallpox vaccines. Given new epidemiological and vaccine-related developments, a Working Group has been established to revise the relevant data on the use of vaccines against smallpox, monkeypox and other orthopoxviruses. Specifically, the Working Group is tasked to review the evidence with respect to use of smallpox and monkeypox vaccines in three specific areas of public health concern, namely global health security, occupational health and safety, and prevention and control of monkeypox and other orthopoxvirus infections. Based on this review of evidence, SAGE will be asked to propose updated recommendations. 

Composition

SAGE Members

• Kathy Neuzil, University of Maryland, USA (Chair of the Working Group)
• Anthony Scott, KEMRI-Wellcome Trust Research Programme in Kilifi, Kenya

Experts

• Joel Breman, Fogarty International Centre, USA.
• Clarissa Damaso, Federal University of Rio de Janeiro, Brazil.
• Poh Lian Lim, National Centre for Infectious Diseases, Singapore.
• Kristine Macartney,  National Centre for Immunisation Research and Surveillance (NCIRS), Australia.
• Raina MacIntyre, University of New South Wales, Australia.
• Heidi Meyer, Paul Ehrlich Institute, Germany.
• Afework Assefa Mitiku, Independent consultant, Ethiopia.
• Andreas Nitsche, Robert Koch Institute, Germany.
• Gregory Poland, Mayo Clinic College of Medicine, USA
• Agam Rao, US Centers for Disease Control and Prevention, USA.
• Anne Rimoin, University of California, USA.
• Tomoya Saito, National Institute of Infectious Diseases, Japan.
• Oyewale Tomori, Redeemer’s University, Nigeria.
  

WHO secretariat

• Rosamund Lewis
• Judith van Holten

Declarations of Interest

All members completed a declaration of interests form. 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.

All the reported relevant interests are summarized below:

    Clarissa Damaso:

• Her institution receives research grants from the Brazilian public funding agencies, the Bill and Melinda Gates Foundation and Tonix Pharmaceuticals to study the genotypic diversity and phylogenetic relationships of the historical Brazilian smallpox vaccine with other historical smallpox vaccines from the late XIX and early XX centuries. These interests were perceived as non-personal, specific and financially insignificant.

  Poh Lian Lim:

• Serves on the expert committee on COVID-19 vaccination and appointed by the Ministry of Health, Singapore. This interest was perceived as non-personal, non-specific and financially insignificant.
• Serves on the expert committee on immunizations and appointed by the Ministry of Health, Singapore. This interest was perceived as non-personal, non-specific and financially insignificant.
• Serves on the independent allocation of vaccines group (IAVG) as chair. This interest was perceived as non-personal, non-specific and financially insignificant.

  Raina Macintyre:

• Her institution receives research grants from Sanofi to study the burden of influenza in adults. This interest was perceived as non-personal, non-specific and financially significant
• Her institution receives funds from Moderna for her role as principal investigator in the CMV Victory trial. This interest was perceived as non-personal, non-specific and financially significant*.
• Her institution received research grants from Seqirus for a project on the burden of influenza in adults. This interest was perceived as non-personal, non-specific and financially significant*.
• Her institution received funds from Emergent Biosolutions, Bavarian Nordic, Siga Technologies and Meridien Medical Technologies for the Pacific Eclipse biothreat simulation. These interests were perceived as non-personal, specific and financially significant*.
• Her institution received funds from Orebro Hospital for her role as principal investigator in the influenza and myocardial infarction trial. This interest was perceived as non-personal, non-specific and financially significant*.
• Serves on the Flucelvax advisory board of Seqirus. This interests were perceived as non-personal, non-specific and financially insignificant.
• Served on the pneumococcal vaccine advisory board and FluAD of Seqirus. These interests were perceived as non-personal, non-specific and financially insignificant.
• Served on the pneumococcal vaccine advisory board of Pfizer. This interest was perceived as non-personal, non-specific and financially insignificant.
• Served on the Fluzone High dose advisory board of Sanofi. This interest was perceived as non-personal, non-specific and financially insignificant.
• Served on the smallpox and monkeypox roundtable of Bavarian Nordic. This interest was perceived as non-personal, specific and financially insignificant.
• Serves as a member of the NHMRC National COVID-19 Health and Research Advisory Committee meeting 2020 and as a member of COVID Antibody Working group (National COVID-19 Health and Research Advisory Committee meeting 2020) from the Australian government. This interest was perceived as personal, non-specific and financially insignificant.
• Serves as a member of the NSW Health COVID-19 vaccine advisory group 2020 from the NSW government. This interests was perceived as non-personal, non-specific and financially insignificant.

    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 t.
  - Safety and reactogenicity of HTNV, PUUV, and combination HTNV/PUUV DNA vaccine from Geneva Foundation
  - Double-Blind, Randomized, Pacebo-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 receives research support for a Phase 3A study of human rotavirus vaccine vaccine in healthy infants 6-12 weeks of age (ROTA-090) from GSK. This interest was perceived as non-personal, non-specific and financially significant*.
• 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).
  This interest was 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, non-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, non-specific and financially significant*.
• Serves as an investigator on for the phase I/II study of the Pfizer mRNA coronavirus vaccine grant, with a grant to her institution. This interest was perceived as nonpersonal, specific and financially significant*.
• Serves as an investigator on a grant from University of Washington for a COVID-19 post-exposure propylaxis study of hydroxychloroquine. This interest was perceived as non-personal, specific and financially significant*.
• Co-chair of the NIH COVID 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 Evalution Units. The plan is to test COVID vaccines and monoclonals from multiple manufacturers – Moderna, Sanofi, Janssen, Regeneron and others. This interest was perceived as non-personal, specific and financially significant*.

    Gregory Poland

• Receives funds as a member of the scientific advisory board from Atria, GSK, Merck, Moderna and Valneva. These interests were perceived as personal, non-specific and financially significant*.
• Receives funds for consulting and advisory work from 3D Communications, AstraZeneca, Eli Lily, Emergent Biosolutions, Exelixis, Inc, Genevant, Janssen Global Services, Ocugen, Regeneron, Syneos and Vyriad. These interests were perceived as personal, specific and financially significant*.
• Receives benefits from commercial entity from Terrapin, Elsevier and the National Foundation for Infectious Diseases. These interests was perceived as personal, non-specific and financially significant*.

  Agam Rao

• Served as lead for the USA Centers for Disease Control (CDC)’s Orthopoxvirus ACIP workgroup. 
  This interest was perceived as non-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 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”. 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 Working Group member’s research unit needs to be declared.