SAGE Working Group on Varicella and Herpes Zoster Vaccines (established May 2012)
Terms of Reference
The Working Group will be asked to review the evidence, identify the information gaps, and guide the work required to address the information gaps and formulate proposed recommendations in preparation for a SAGE review of the use of varicella and herpes zoster vaccines. This will then lead to an updating the current (1998) varicella vaccine position paper.
The Working Group will specifically be asked to identify and review:
- data regarding the global prevalence and burden of disease caused by varicella and herpes zoster according to country development status
- issues related to varicella and herpes zoster surveillance
- the safety, effectiveness and immunogenicity profile of varicella and herpes zoster vaccines including that of vaccine combinations such as MMRV
- the duration of protection following immunization
- the impact of co-administration of varicella and herpes zoster vaccines with other vaccines
- the impact of varicella vaccination on immunocompromised individuals
- country experiences with introduction and use of varicella vaccines (in countries with information that allows a robust analysis)
- the potential for widespread childhood vaccination to reduce natural boosting through varicella virus circulation in the community and increase the risk of zoster in the adult and elderly population
- evidence on the cost-effectiveness of different approaches, in particular in low and low-middle income countries (as per WHO guidelines)
- additional critical issues that need to be considered in updating the current vaccine position paper.
The review of vaccine safety will consider of a review by the Global Advisory Committee on Vaccine Safety, and that on cost-effectiveness will link with the Immunization and Vaccines related Implementation Research (IVIR) Advisory Committee (formerly known as QUIVER).
The formulation of recommendations will be evidence-based and follow the principles set in the Guidance For The Development Of Evidence-Based Vaccine Related Recommendations
- Jon Abramson, Chair of Working Group, Department of Paediatrics, Wake Forest University School of Medicine, U.S.A.
- Paba Palihawadana, Central Epidemiological Unit, Ministry of Health, Sri Lanka
- Marc Brisson, Département de Médecine Sociale et Préventive, Laval University, Canada
- Philip LaRussa, Division of Pediatric Infectious Diseases, Department of Pediatrics, Columbia University, U.S.A.
- Raina MacIntyre, School of Public Health and Community Medicine, University of New South Wales, Australia (was nominated in February 2013 replacing Sin Yun Cheah)
- Hanne Nøkleby, Division of Infectious Disease Control, Norwegian Institute of Public Health, Norway
- Bolutife Ayokunnu Olusanya, Department of Ophthalmology, University College Hospital, Nigeria
- Jane Seward, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, U.S.A.
- Claudia Vujacich, Foundation for Infectious Diseases, FUNCEI, Argentina
- Dapeng Yin, National Immunization Programme, Chinese CDC, China
- Philippe Duclos
- Melanie Schuster
DECLARATION OF INTERESTS FOR WHO EXPERTS
All Working Group members completed a declaration of interests. Five members reported relevant interests. The reported relevant interests are summarized below:
• Received consultancy fees in 2010 from GlaxoSmithKline for work relating to the Rotavirus vaccine. This interest was assessed as personal, non-specific and financially insignificant.*
• His department receives an unrestricted research grant from Merck & Co. for implementation of studies on zoster and cervical cancer quality of life and HPV modeling for which he is the principal investigator. Dr. Brisson has no personal income from these projects. This funding is on-going and will cease at the end of 2012. This interest was assessed as non-personal, specific and financially significant.*
Sin Yun Cheah:
• Was employed by Merck Sharp and Dohme (I.A.) Corp., Singapore, from 2005-2010. This interest was assessed as personal, specific and financially significant.**
• A member within the same lab group receives funding from Merck & Co. for a project to perform varicella polymerase chain reaction on blinded samples to determine whether the sample contains the vaccine or wild-type virus. Dr. LaRussa was Principal Investigator on this project until Jan 31, 2012. Dr. LaRussa has received no personal funding for this project in the last 6 years. This interest was assessed as non-personal, specific, and financially significant.*
• Her research unit receives funding from Merck for a study on herpes zoster vaccine donor-vaccination of bone marrow transplant donors. This interest was assessed as non-personal, specific and financially significant.*
• Currently serves as a participant on the European Centre for Disease Prevention and Control (ECDC) expert panel to develop guidance for use of the varicella vaccine in Europe. This interest was assessed as non-personal, specific and financially insignificant.*
• Received speaker fees from Janssen Inc. for two talks given on hepatitis in 2011 and 2012. This interest was assessed as personal, non-specific and financially insignificant.*
• Her research department (Foundation Research Unit) received funding from Pharmasset Inc. to conduct a clinical trial on chronic hepatitis B treatment which finished in 2009. Dr. Vujacich was the principle investigator for this clinical trial. This interest was assessed as personal, non-specific and financially significant.*
• Her research department (Foundation Research Unit) currently receives funding from Merck & Co. for an observation epidemiologic trial on the burden of zoster disease. The trial began in 2007 and the recruitment for this trial is currently open, expected to close in 2012. Dr. Vujacich is the principle investigator of this trial. This interest was assessed 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 10,000 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 Sin Yun Cheah is now working for the Health Science Authority in Singapore and has not worked for Merck Sharp and Dohme (I.A.) Corp. for over a year, this interest was assessed not to constitute a conflict of interest. Therefore, it was concluded that Sin Yun Cheah could participate in full in all discussions.