Immunization, Vaccines and Biologicals

SAGE Working Group on Pertussis Vaccines (established March 2013)

Terms of Reference

In the light of the recent resurgence of pertussis in some industrialized countries with their toll in terms of infant deaths it was agreed between SAGE and WHO that a new working group (on pertussis would be established to prepare for a SAGE review of the data and to consider updating current pertussis vaccine recommendations as published in the 2010 pertussis vaccine position paper. This is also an opportunity for SAGE to review new data on the effectiveness of various vaccination strategies aimed at reducing infant mortality as well as the pertussis related outcome of the Vaccine schedule optimization project.

Specifically the working group will be asked to:

  • Review epidemiological data from countries that have or not experienced a resurgence of pertussis, in particular data that relates to the quality and duration of protection of protection for wP and aP vaccines
  • Review, in the context of the above, accumulated data on the usefulness of the following strategies to prevent early mortality
    • Role of vaccination of adolescents and adults
    • “Cocooning”
    • Vaccination of pregnant and lactating mothers
    • Vaccination of new-borns

  • Update estimates of effectiveness of 1 or 2 dose schedules against mortality
  • Create optimal primary vaccination schedule and timing of booster dose(s)
  • Propose, based on the above and as necessary, an update of the current recommendations on the use of wP/aP vaccine.

Composition

SAGE Members

  • Claire-Anne Siegrist (Working Group Chair), Department of Pediatrics, University of Geneva, Switzerland
  • Elizabeth Miller (SAGE member until January 2014), Immunisation Department, Colindale, UK
  • Piyanit Tharmaphornpilas, National Immunization Program, Ministry of Public Health, Nonthaburi, Thailand

Experts

  • Tom Clark, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, USA
  • Kathryn Edwards, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, USA
  • Nicole Guiso, Institut Pasteur Research Unit, Institut Pasteur, Paris, France
  • Scott A. Halperin, Canadian Center for Vaccinology, Dalhousie University, Halifax, Canada
  • Teeranart Jivapaisarnpong, Institute of Biological Products, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
  • Daniel Levy-Bruhl, Infectious Diseases Department, Institut de Veille Sanitaire, Saint-Maurice, France
  • Peter McIntyre, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Sydney, Australia
  • Gabriela Moreno, Departments of Epidemiology and Immunizations, Ministry of Health, Santiago, Chile
  • Carl Heinz Wirsing von König, National reference laboratory for Bordetella infections, Krefeld, Germany

WHO Secretariat

  • Philippe Duclos

Declarations of Interest

All Working Group members completed a declaration of interests. Eight members reported relevant interests. The reported relevant interests are summarized below:

Tom Clark
  • Received two travel grants in 2010 and in 2013 to represent CDC at the Global Pertussis Initiative meetings by Parexel using educational grants from sanofi pasteur. This interest was assessed as non-personal, specific and financially insignificant*.
Kathryn Edwards
  • Her institution receives research support from the National Institutes of Health (NIH) and CDC for studies, among others, on Tdap vaccines in pregnant women and vaccine safety of pertussis vaccine. This interest was assessed as personal, specific and financially significant*.
  • Her institution received research support from Novartis to complete a review of the data on meningococcal vaccine. This interest was assessed as non-personal, non-specific and financially significant*.
Nicole Guiso
  • Her institution received funding in 2010-2011 from sanofi pasteur/MSD and GlaxoSmithKline for training of health care workers and for symposia on pertussis. This interest was assessed as non-personal, specific and financially significant*.
  • Her institution received funding in 2012 from sanofi pasteur/MSD and GlaxoSmithKline for training of health care workers and for symposia on pertussis. This interest was assessed as non-personal, specific and financially significant*.
Scott Halperin
  • Receives consultancy fees for membership of ad hoc advisory boards with companies that have an interest in pertussis vaccines (GlaxoSmithKline, sanofi pasteur, Novartis, Immunovaccine). Honoraria and travel expenses are funded by the named companies. This interest was assessed as non-personal, specific and financially significant*.
  • Serves currently as member an advisor to governmental agencies (National Advisory Committee on Immunization (NACI), Public Health Agency of Canada; Pertussis Vaccines Working Group, Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, US; Nova Scotia Department of Health and Wellness, Canada) with tasks as ad-hoc advisor on pertussis related questions for governments (Fraser Health, BC; Saskatchewan; New Brunswick; Nunavut). This interest was assessed as non-personal, specific and financially insignificant*.
  • Serves as primary investigator for a study on Tdap in pregnant women funded by sanofi pasteur. This interest was assessed as non-personal, specific and financially significant*.
  • Serves as primary investigator for multiple studies, surveillance projects and clinical trials on influenza vaccines funded by GlaxoSmithKline. This interest was assessed as non-personal, non-specific and financially significant*.
  • Serves as primary investigator of a rotavirus vaccine immunization project funded by GlaxoSmithKline. This interest was assessed as non-personal, non-specific and financially significant*.
  • Serves as primary investigator for the assessment of KAB (surveys and focus groups) on adult immunization including Tdap co-funded by GlaxoSmithKline and sanofi pasteur. This interest was assessed as non-personal, specific and financially significant*.
  • Serves as co-investigator on multiple studies on influenza and community acquired pneumonia funded by GlaxoSmithKline.This interest was assessed as non-personal, non-specific and financially significant*.
  • His institution receives consultancy fees for the expert’s talks at symposia on pertussis, among others, sponsored by GlaxoSmithKline, Novartis, sanofi pasteur/MSD and GlaxoSmithKline. This interest was assessed as non-personal, specific and financially significant*.
  • Holds a patent for a triple adjuvant vaccine combined with pertussis toxoid, with the respective research funded by Bill & Melinda Gates Foundation. This interest was assessed as non-personal, specific and financially insignificant*.
Peter McIyntre
  • Until 2012, served as the lead investigator on a randomized trial on monovalent acellular pertussis vaccine funded by the Australian National Health and Medical Research Council. As part of this grant, GlaxoSmithKline provided the monovalent vaccine. This interest was assessed as non-personal, specific and financially significant*.
  • His institution conducted since 1997, three surveys on pertussis seroprevalence. As part of this grant, GlaxoSmithKline has provided the pertussis toxin. This interest was assessed as non-personal, specific and financially significant*.
  • His institution is conducting a study funded by GlaxoSmithKline comparing DTPa to dTaP in infants. This interest was assessed as non-personal, specific and financially significant*.
  • Serves as Chair of the Pertussis Working Party of the Australian Technical Advisory Group on Immunisation. This interest was assessed as non-personal, specific and financially insignificant*.
Claire-Anne Siegrist
  • Her university receives funding from sanofi pasteur, NasVax Ltd and DBV Technologies for conducting research in vaccine adjuvants and seroepidemiology of pneumococcal infections. This interest was assessed as non-personal, non-specific and financially significant*.
  • Developed and owns the Viavac immunization management software destined to support Swiss health care professionals to follow the official immunization recommendations. Her ownership in the enterprise generates royalties of less than 10,000 USD per annum. This interest was assessed as personal, non-specific and financially insignificant*.
  • Received in 2007-2010 partial travel grants from sanofi pasteur and Wyeth to attend two scientific meetings on pneumococcal vaccines. This interest was assessed as personal, non-specific and financially insignificant*.
Piyanit Tharmaphornpilas
  • Received in 2011 a travel grant from a joint venture of the Thai Government Pharmaceutical Organization - Merieux Biological Product to attend the Re-invigorating Immunisation Policy Implementation and Success: From Parent to Partner and from Broad to Engagement. This interest was assessed as personal, non-specific and financially insignificant*.
  • Received in 2010 a travel grant from sanofi pasteur to attend the 8th Asia-Pacific Travel Health Conference. This interest was assessed as personal, non-specific and financially insignificant*.
Carl Heinz Wirsing von König
  • Receives consultancy fees for being member of the steering committee of the “Global Pertussis Initiative” from sanofi pasteur/MSD. This interest was assessed as personal, specific and financially significant*.
  • Receives consultancy fees from GlaxoSmithKline Pharma GmbH (and GlaxoSmithKline Biologicals SA) for giving talks on pertussis/ pertussis vaccines for them. 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 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”.

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