Terms of Reference

The Working Group will be requested to review the scientific evidence and relevant programmatic considerations to assess whether there is sufficient evidence to inform a revision of the global policy on the use of influenza vaccines, and for subsequent updating of the WHO position paper on influenza vaccines.

Specifically the Working Group will be asked to review the following elements:

• the evidence on the effect of prior immunization on the efficacy and effectiveness of seasonal influenza vaccines, and whether a change in policy would result in improved public health outcomes;
• the evidence on the effectiveness of adjuvanted seasonal influenza vaccines in pediatric populations;
• the evidence on the effectiveness of improved formulations for influenza vaccines for older adults and other risk groups;
• the evidence on the effectiveness of live attenuated influenza vaccines.

Composition

SAGE members

• Rakesh Aggarwal: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
• Andrew J. Pollard: University of Oxford, United Kingdom (Chair of the Working Group);

Experts

• Jon Abramson: Wake Forest Baptist Health, USA;
• Joseph Bresee: Centers for Disease Control and Prevention, USA;
• Cheryl Cohen: National Institute of Communicable Diseases, South Africa;
• Rebecca J. Cox: University of Bergen, Norway;
• Luzhao Feng: Chinese Center for Disease Control and Prevention, China;
• Kawsar Talaat: Johns Hopkins Bloomberg School of Public Health, USA;
• Hanna Nohynek: National Institute for Health and Welfare, Finland;
• Richard Pebody: Public Health England, United Kingdom;
• Sheena Sullivan: WHO Collaborating Centre for Reference and Research on Influenza, Australia;
• Bryna Warshawsky: Public Health Ontario; Ontario Agency for Health Protection and Promotion, Canada;
• Maria Zambon: Public Health England, United Kingdom.

WHO secretariat

• Martin Friede

Declaration of interests

All members completed a declaration of interests form. One SAGE member and seven 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. The reported relevant interests are summarized below:

Cheryl Cohen

• Her research institution1 received an educational grant from Sanofi Pasteur to hold an influenza symposium (2016). This interest was assessed as non-personal, specific, and financially significant*.
• Her research institution1 currently receives and received the following grants from the US Centres for Disease Control and prevention:
• research on the Epidemiology, Prevention, Vaccine Effectiveness and Treatment of Influenza and Other Respiratory Viruses in South Africa (2016- current);
• maintenance of Influenza Surveillance Capacity by National Health Authorities Outside the United States (2016- current);
• effectiveness of trivalent inactivated influenza maternal vaccination and evaluation of the vaccination program among pregnant women and their newborns in South Africa (2014-2015);
• surveillance for invasive pneumococcal disease in infants (2014-2015);
• sustaining surveillance networks and response to seasonal and pandemic influenza (2013-2015);
• investigation of influenza burden, interaction with other pathogens and nosocomial transmission at sentinel surveillance sites (2012-2015);
• healthcare Utilization Survey - Pietermaritzburg, South Africa (2012-2014);
• household transmission of influenza amongst HIV-infected and -uninfected individuals in South Africa (2012-2014);
• the contribution of emerging viruses, tuberculosis and atypical bacterial pneumonias to severe acute respiratory illness (2011-2014);
• This interest was assessed as non-personal, specific, and financially significant*.
• Her research institution1 received a grant from Bloomberg School of Public Health, Johns Hopkins University (Subagreement under the Accelerated Vaccine Introduction Initiative (AVI) funded by the Program for Appropriate Technology in Health (PATH)) for a case-control study to estimate effectiveness of a pneumococcal conjugate vaccine (PCV-13) against invasive pneumococcal disease in South Africa (2010-2015). This interest was assessed as non-personal, non-specific, and financially significant*.
• She travelled in 2016 and 2017 to an influenza advisory group meeting and travel costs were covered by Parexel. This interest was assessed as personal, specific, and financially significant*.

Rebecca J. Cox

• Her research institution2 currently receives a research grant from the European Union Innovative Medicines Initiative on Standardization and Development of Assays for Assessment of Influenza Vaccine Correlates of Protection (FLUCOP) from the European Union (EU) (2015-2020).This interest was assessed as non-personal, specific, and financially significant*.
• Her research institution2 currently receives a research grant termed European Union Framework Programme 7 "Univax" on a Universal Influenza Vaccine through Synthetic, Dendritic Cell-Targeted, Self-Replicating ribonucleic acid (RNA) Vaccines from the European Union (EU) (2013-2018). This interest was assessed as non-personal, specific, and financially significant*.
• She is a member of the secretary of Society of Influenza and other Respiratory Virus Diseases (ISIRV) (2015 -current) and is a member of the board since (2011 - current). This interest was assessed as non-personal, specific, and financially insignificant*.
• She serves as an advisor on the Pandemic and Epidemic committee which provides advice to the Department of Health and Care Services, in Norway. (2010 - current). This interest was assessed as non-personal, specific, and financially insignificant*.

Hanna Nohynek

• She is a member of the Finnish National Immunization Technical Advisory Group (NITAG) secretariat (2012- current). This interest was assessed as personal, specific, and financially insignificant.
• Her research institution3 is the recipient of a grant to measure effectiveness of pneumococcal vaccination by GlaxoSmithKline (GSK) (2009-2018). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her research institution3 is a member of the Innovative Medicines Initiative (IMI) DRIVE (2017 - 2022 conditionally) and the European Union (EU) Director General (DG) Research (Influenza - Monitoring Vaccine Effectiveness (I-MOVE+)) (2015-2018) and the European Centre for Disease Prevention and Control (ECDC) (I-MOVE) (2016-2017) network measuring effectiveness of influenza vaccination in the EU context. She is a member of this research group validating the methodology used. This interest was assessed as non-personal, specific, and financially insignificant*.

Richard Pebody

• He is member of the ad hoc Joint Committee on Vaccination and Immunisation (JCVI) Influenza Working group, UK (2008 - to date). This interest was assessed as non-personal, specific, and financially insignificant*.
• He is the chair of the ECDC European Influenza Surveillance Network (EISN) working group (2012 - current) This interest was assessed as non-personal, specific, and financially insignificant*.
• His research institute4 is a member of the European Union (EU) Horizon 2020 funded (Influenza - Monitoring Vaccine Effectiveness (I-MOVE+)) (2015-2018) and the European Centre for Disease Prevention and Control (ECDC) (I-MOVE) network measuring effectiveness of influenza vaccination in the EU context. This interest was assessed as non-personal, specific, and financially insignificant*.

Andrew Pollard

• His institution5 received research support until 2014 from GSK on Pneumococcal vaccine. This interest was assessed as non-personal, specific and financially significant*.
• His institution5 received research support until 2016 from Okairos on Respiratory Syncytial Virus (RSV) vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support until 2015 from Pfizer on Meningococcal B vaccine, meningitis epidemiology and pneumococcal epidemiology. This interest was assessed as non-personal, specific and financially significant*.
• His institution5 received research support until 2014 from Novartis on Meningococcal B vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study an Ebola vaccine developed by Janssen (2015-current) funded by a European Commission Innovative Medicines Initiative (IMI) grant (EBOVAC). This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study on the cause of fever with Bexsero funded by a European Commission grant (EU- Childhood Life-threatening Infectious Disease Study (EUCLIDS)) (2011-2017). The vaccine for the study is provided by Novartis/GSK. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study on the efficacy of a typhoid vaccine (Tybar-CV) produced by Bharat Biotech, India (2013-2016) funded by the Bill and Melinda Gates Foundation. No funding was received from Bharat Biotech, the grant was funded by the Bill and Melinda Gates Foundation. This interest was assessed as non-personal, specific and financially significant*.
• His institution5 received research support on a grant for a study on the genes expressed in children when they receive an adjuvanted influenza vaccine (FluAd, Novartis) funded by a European Commission grant (Advanced Immunization Technologies (ADITEC)) (2011-2016). This interest was assessed as non-personal, specific and financially significant*.
• His institution5 received research support on a grant for a study on the treatment of encephalitis in children with intravenous immunoglobulin (supply and distribution funding agreement with CSL Behring) funded by the National Institute for Health Research (2015-2020). This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study on the infant pneumococcal vaccine schedule in Nepal (2013-2017), funded by Gavi, the Vaccine Alliance. This interest was assessed as non-personal, specific and financially significant*.
• His institution5 received unrestricted educational grants from Novartis/GSK/Astra Zeneca/Sanofi Pasteur MSD in 2014; Novartis/GSK/Astra Zeneca in 2015 and Pfizer/GSK/Astra Zeneca in 2016 and from Gilead/MSD/GSK/Astra Zeneca in June 2017 for a course on infection and immunity in children. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support until 2014 from Sanofi Pasteur MSD (SPMSD) on a hexavalent infant vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study on pertussis vaccines funded by a European Commission grant (Pertussis Correlates of Protection (PERISCOPE)) (2016-current). This interest was assessed as non-personal, non-specific and financially significant*.
• His institution5 received research support on a grant for a study pneumococcal pneumonia and carriage by a European Commission Horizon 2020 grant (2016-2020). This interest was assessed as non-personal, specific and financially significant*.

Kawsar Talaat

• Her research institution6 had a research contract from LimmaTech Biologics for a Phase2b Shigella vaccine study (2015-2017). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her research institution6 currently has a research contract from Valneva Austria for a study of Dukoral (oral cholera vaccine) (2017-2019). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her research institution6 currently receives research funding from the Bill and Melinda Gates foundation for a pandemic influenza vaccine study (2017-2019). This interest was assessed as non-personal, specific, and financially significant*.
• Her research institution6 currently has a research contract from the US-National Institutes of Health for an Ebola vaccine study (2017-2019). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her research institution6 currently receives a research grant from the US Department of Defense for a study regarding protective efficacy of orally delivered bovine serum immunoglobulin (BSIgG) specific for the colonization factor CS6 following challenge with the CS6-expressing Enterotoxigenic E. coli (ETEC) strain B7A (2016-2018). This interest was assessed as non-personal, non-specific, and financially insignificant*.
• She will be serving as member on the Safety Monitoring Committee (SMC) for Takeda's Phase 1 Purified Inactivated Zika virus vaccine trial in Flavivirus Naïve and Primed Healthy Adults. This study is funded by the U.S. Biomedical Advanced Research and Development Authority (starting in 2018). This interest was assessed as personal, non-specific, and financially significant*.

Bryna Warshawsky

• She is a member of the National Advisory Committee on Immunization (NACI) Influenza Working Group in Canada, where she contributes to recommendation formulation with regard to influenza vaccines. As part of employment at Public Health Ontario, she provides advice regarding influenza vaccine-related issues to stake holders (2014- current). This interest was assessed as non-personal, specific, and financially insignificant*.

Maria Zambon

• She is a member of the ad hoc Joint Committee on Vaccination and Immunisation (JCVI) Influenza Working group, UK (1998- current). This interest was assessed as non-personal, specific, and financially insignificant*.
• She is a Board Member of International Society of Influenza and other Respiratory Virus Diseases (ISIRV) (2012- current). This interest was assessed as non-personal, specific, and financially insignificant*.
• Her institution7 received a grant from the Medical Research Council regarding Zika serological test development rapid response (2016-2017). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution8 received a grant from the Italian Government Instituto Superiore di Sanita regarding serological investigation of coronaviruses (2015-2017). This interest was assessed as non-personal, non-specific, and financially significant*.
• Her institution7 currently receives a grant from the Medical Research Council regarding the development of interventions for MERS (DPFS) (2017-2020). This interest was assessed as non-personal, non-specific, and financially significant*.

1National Institute for Communicable Disease, Centre for Respiratory Disease and Meningitis, South Africa
2Influenza Centre, Department of Clinical Science, University of Bergen, Norway
3Infectious Disease Control and Vaccinations Unit, Department of Health Security, National Institute for Health and Welfare, Finland
4 Respiratory Diseases Department, Public Health England, United Kingdom
5 Department of Paediatrics, University of Oxford, United Kingdom
6 International Health Division, Global Disease Epidemiology and Control, Johns Hopkins Bloomberg School of Public Health, USA
7 Reference Microbiology at Public Health England (PHE), United Kingdom

* 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".