Terms of Reference

Full Terms of Reference in PDF format

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

The areas to be covered include:

• the global prevalence and burden of disease, particularly in young children, caused by RSV infection. RSV disease and burden in older adults might also be addressed
• safety, efficacy, duration of protection, schedules, and co-administration of RSV immunization products particularly those to protect young children. Vaccines for older adults may also be assessed.
• data on cost-effectiveness and cost-utility of RSV immunization products.
• programmatic and feasibility of RSV immunization product introduction into routine immunization schedules and/or antenatal care visits.
• acceptability and equity impact of RSV immunization.

The working group will review evidence and draft recommendations for SAGE on 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

• Kathleen Neuzil, University of Maryland School of Medicine, USA (Chair of the Working Group)
• Kim Mulholland, Murdoch Children’s Research Institute, Australia

Experts

• Fatima Aziz, Aga Khan University, Pakistan
• Azucena Bardají, University of Barcelona, Spain
• Nelly Bosire, Kenya Paediatric Research Consortium, Kenya
• Ghassan Ddaibo, American University of Beirut, Lebanon           
• Katherine Gibney, University of Melbourne, Australia
• Jacob John, Christian Medical College Vellore, India
• Ruth Karron, Johns Hopkins Bloomberg School of Public Health, USA
• Meredith McMorrow, US Centers for Disease Control and Prevention, USA        
• Emmanuel Mugisha, PATH Uganda, Uganda
• Patrick Munywoki, US Centers for Disease Control and Prevention Kenya, Kenya
• Harish Nair, University of Edinburgh, UK
• Clint Pecenka, PATH, USA

WHO secretariat

• Daniel Feikin
• Erin Sparrow

Declarations of Interest

All members completed a declaration of interest form. All interests were assessed not to constitute a conflict of interest in relation to the Working Group’s terms of reference. It was concluded that all members could take part in full in all of the discussions and formulation of the recommendations. The reported relevant interests are summarized below:

Ghassan Ddaibo

• Receives funding for serving as an advisor for COVID and PCV vaccines from Pfizer and MSD. This was assessed as personal, non-specific, and financially insignificant.* 
• His institute received a research grand from Sanofi for influenza surveillance. This was assessed as non-personal, non-specific, and financially significant.* This was completed in 2018.
• His institute receives research grants from Pfizer for pneumococcus and meningococcus surveillance. This was assessed as non-personal, non-specific, and financially significant.* 
• His institute received a research grant on RSV therapeutics from ARK Biosciences. This was assessed as non-personal, specific, and financially significant.*  This was completed in 2019 and is therefore expired.
• His research institute received a grant from Sanofi for a meningococcal vaccine trial. This was assessed as non-personal, non-specific, and financially significant.* This was completed in 2022.
• Receives honoraria from the vaccine industry to deliver lectures. None of the personal payments were specific to RSV. This was assessed as non-personal, non-specific, and financially significant.* 

Katherine Gibney

• Receives funding from the Australian Government for research on group A strep. This interest is significant and non-specific. *   
• Is a member of Australia’s NITAG and working group on RSV, this is specific and financially insignificant.* 

Ruth Karron

• Consulted for Sanofi Pasteur in 2021 on RSV. This interest was perceived as personal, specific and financially insignificant*.
• Her institute received a research grant from Sanofi Pasteur in 2022 for research on a candidate vaccine that will not be reviewed by the working group, this was assessed as non-personal, specific, and financially significant.* 

Kim Mulholland

• Serves as a member on ISPPD board. This interest was perceived as personal, non-specific and financially insignificant *.
• Serves as principal investigator on COVID-19 trial in Mongolia, Indonesia, Australia, funded by CEPI. This interest was assessed as non-personal, non-specific and financially significant.*
• Serves as collaborative member of an observational study of adult pneumonia in Mongolia, funded by Pfizer. This project is led by a member of his group. This interest was perceived as non-personal, non-specific and financially insignificant.*
• Serves as principal investigator on Vietnam pneumococcal vaccine trials 1 and 2 in Ho Chi Minh City, funded by the Gavi Alliance and the Bill and Melinda Gates Foundation. This interest was assessed as non-personal, non-specific and financially significant.*
• Serves as investigator on an evaluation of PCV schedules in Nha Trang in Vietnam funded by the Bill and Melinda Gates Foundation. This interest was assessed as non-personal, non-specific and financially significant.*
• Served until 2022 as principal investigator on the evaluation of the impact of PCV in Mongolia funded by GAVI. This interest was assessed as non-personal, non-specific and financially significant.*
• 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.*
• Serves as a principal investigator on HPV detection in young women 5 years following the 4-valent HPV vaccine in Mongolia funded by the Bill and Melinda Gates Foundation. This interest was assessed as non-personal, non-specific and financially significant.*
• Serves as Principal Investigator on a study of HPV vaccination and disease in Ethiopia, funded by UKRI and BMGF. This interest was assessed as non-personal, non-specific and financially significant.*
• Serves as Principal Investigator on a study of HPV vaccination of female sex workers in Vietnam, funded by UKRI. 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 IVI. This interest was assessed as non-personal, non-specific and financially significant.*

Harish Nair

• Serves on RSV advisory boards of Sanofi, GSK, Merck, ReViral, Pfizer for which his institute receives funding to advise the on RSV epidemiology/burden of disease and . to organize a symposium for Sanofi on RSV in 2020, 2021 and 2022. This interest was perceived as non-personal, specific, most of these were financially insignificant with the exception of Sanofi where the funds also included the organization of symposium.*
• His research institute received research funds for grants related to RSV, influenza, COVID and hMPV from IMI, Foundation for influenza epidemiology, NIHR, WHO, Pfizer and Icosavax. This interest was perceived as non-personal, specific and financially significant*.
• Received honoraria in 2022 to his institute for speakership on RSV from Sanofi. This interest was perceived as non-personal, 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 PI for NIH-funded Collaborative Influenza Vaccine Innovation Center (CIVICs) program. This interest was perceived as non-personal, non-specific and financially significant*.
• 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, and an influenza challenge study. 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 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*.
• Her institution receives research support for the following studies. These interests were perceived as non-personal, non-specific and financially significant*.
  • 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.
• Serves 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*.
• 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 Evaluation Units. This interest was perceived as non-personal, non-specific and financially significant*.
• Serves as principal investigator for the 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*.
• Serves 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*.

Clint Pecenka

• His institute received RSV funding, not related to research on a particular RSV vaccine candidate, from Bill and Melinda Gates Foundation. This interest was perceived as non-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”.