Last updated: 25 May 2023

Terms of Reference

Full Terms of Reference in PDF format

The SAGE WG will be expected to formulate critical questions, perform or coordinate, assessments of the evidence in accordance with the SAGE process for evidence–review, GRADE`ing and development of recommendations.  

The areas to be covered include 

• the global prevalence and burden of disease caused by dengue virus infection, including outbreaks 
• safety, efficacy, duration of protection, schedules, and co-administration of TAK-003 dengue vaccine; 
• data and label changes for CYD-TDV since 2018 
• data on cost-effectiveness and cost-utility of dengue vaccination 
• programmatic and feasibility of dengue vaccine introduction into routine immunization schedule 
• acceptability and equity impacts of dengue vaccination 
• Safety, efficacy, duration of protection of TV003/005

The working group will provide options for policy and strategy development and describe the broader implications of those options; present  the results of the evidence review as requested by WHO; highlight knowledge gaps and research questions from the review of evidence, including an assessment of vaccine products in the pipeline and needs for future products. 

Composition

SAGE Members

• Professor Punnee Pitisuttithum, Mahidol University, Thailand (Chair of the Working Group)
• Professor Kim Mulholland, Melbourne, Murdoch Children’s Research Institute, Australia 
  

Experts

• Kathryn Anderson, SUNY Upstate Medical University, USA
• Gabriela Paz-Bailey, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Puerto Rico
• Hannah E. Clapham, National University of Singapore, Singapore
• Neil M. Ferguson, Imperial College London, London 
• P.S. Indu, Govt. Medical College,, India
• Rakesh Aggarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences, India
• Yee Sin Leo, National Centre For Infectious Diseases,  Singapore
• Jacqueline Deen, University of the Philippines, Philippines 
• Gonzalo Martin Vazquez-prokopec, Emory University, USA 
• Nilhan Rajiva de Silva, Medical Research Institute, Srilanka
• Selidji Todagbe Agnandji, Lambaréné Medical Research Center, Gabon

WHO Secretariat

• Annelies Wilder-Smith
• Joachim Hombach
  
  

Declaration of Interest

All members completed a declaration of interest form. 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 discussions. The reported relevant interests are summarized below:

Neil Ferguson

• Served until 2021 as Co-Investigator on dengue antiviral candidates research funded by Janssen. This interest was perceived as non-personal, non-specific and financially significant*.

Nilhan Rajiva de Silva

• Serves as a member of clinical trials committee of the local regulatory body to review the Takeda phase III. This interest was perceived as non-personal, non-specific and financially insignificant*.
  

Kathryn Anderson

• Her institution received a grant/research support from Merck to conduct an study on epidemiological and clinical aspects of Dengue in Thailand and Ecuador. This interest was assessed as non-personal, specific and financially significant*
• Serves on the emergent Biosolutions Chikungunya vaccine steering committee. This interest was assessed as personal, specific and financially insignificant*.
• Serves on the DSMB for the Astrazeneca COVID-19 Vaccines Clover Pharmaceuticals. This interest was assessed as personal, specific and financially insignificant*.
• Served until November 2022 on a data adjudication committee for Clover Pharmaceuticals. This interest was assessed as personal, 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”.