@article{473859d744414c81b4edc2c8930c3193,
title = "Meeting report: WHO consultation on Respiratory Syncytial Virus (RSV) vaccine development, Geneva, 25–26 April 2016",
abstract = "Respiratory syncytial virus (RSV) is a leading viral cause of respiratory morbidity and mortality in infants and young children worldwide. Low and middle income countries (LMICs) account for approximately 99% of the global mortality estimates in this population, with up to 200,000 RSV deaths per year. The vaccine product development pipeline is diverse with the most advanced clinical candidate currently in phase III efficacy testing in pregnant women. In addition, a long-acting RSV-neutralizing monoclonal antibody (mAb) to be administered at birth to prevent serious RSV-related respiratory disease is in late stage clinical development, as are additional conventional mAb for use in high-risk infants. Thus, there is a realistic possibility that an effective new intervention to prevent RSV disease will be available in the next 5–10 year horizon. In anticipation of this outcome, the Strategic Advisory Group of Experts for Immunization (SAGE), WHO's vaccine policy recommendation body, reviewed the status of RSV vaccine and monoclonal antibody development in April 2016. Although substantial progress towards licensure has broadened the research agenda to consider intervention impact and cost effectiveness, significant gaps remain in the data that will be needed to inform and support a policy recommendation for implementation. These aspects were the focus of WHO's second consultation on RSV vaccines and single dosage extended half-life mAb for prophylaxis.",
keywords = "Acute lower respiratory illness (ALRI), Licensure, Lower respiratory tract infection (LTRI), Monoclonal antibody, Respiratory Syncytial Virus, SAGE, Vaccine, Wheezing",
author = "Giersing, {Birgitte K.} and Karron, {Ruth A.} and Johan Vekemans and Kaslow, {David C.} and Moorthy, {Vasee S.}",
note = "Funding Information: We gratefully acknowledge participation of the following who attended the WHO consultation for their contribution to the discussions:, Narendra Kumar Arora, Azucena Bardaji, Barcelona Center for International Health Research, Universitat de Barcelona, Barcelona, Spain; The INCLEN Trust International, New Delhi, India; Louis Bont, Wilhelmina Children's Hospital, Netherlands; Harry Campbell, Centre for Global Health Research, University of Edinburgh, United Kingdom; Peter Collins, NIAID, NIH, Bethesda, MD, USA; Janet Englund, Seattle Children's Hospital, University of Washington, Seattle, USA; Barney S. Graham, NIAID, NIH, Bethesda, MD, USA; Eric Karikari-Boateng, Food and Drugs Authority Ghana, Accra, Ghana; Ruth Karron, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; David Kaslow, PATH, Seattle, USA; Shabir A. Madhi, National Institute for Communicable Diseases, Johannesburg, South Africa; Harish Nair, University of Edinburgh, Scotland, United Kingdom; Patricia Njuguna, KEMRI Wellcome Trust Collaborative Research Programme, Kilifi, Kenya; James Nokes, KEMRI Wellcome Trust Collaborative Research Programme, Kilifi, Kenya; Eric Pelfrene, European Medicines Agency; London, United Kingdom; Fernando Polack, Fundaci?n INFANT, Buenos Aires, Argentina; Eric A.F. Simoes, The University of Colorado Health Sciences Center and the Children's Hospital, Denver, USA; Peter Smith, London School of Hygiene and Tropical Medicine, London, United Kingdom; James Southern, Chair Developing Countries Vaccine Regulatory Network, Medicines Control Council, Simon's Town, South Africa. Industry observers included: Allison August, Novavax Inc. Gaithersburg, United States of America; Lars Bastiaanse, J&J, Leiden, The Netherlands; Ilse Dieussaert, GlaxoSmithKline Biologicals, Wavre, Belgium; Filip Dubovsky, MedImmune, Gaithersburg, USA; Amy Fix, Novavax Inc. Gaithersburg, USA; Gregory Glenn, Novavax, Maryland, USA; Pamela Griffin, MedImmune, Gaithersburg, USA; Ouzama Henry, GlaxoSmithKline Biologicals, Wavre, Belgium; Deborah Higgins, PATH, Seattle, USA; Rosalind Hollingsworth, Sanofi Pasteur, Swiftwater, USA; Judith Kallenberg, GAVI secretariat, Geneva, Switzerland; Clint Pecenka, PATH, Seattle, USA; Jeff Roberts, Food and Drug Administration, CBER, Bethesda, USA; Hanneke Schuitemaker, J&J, Leiden, The Netherlands; Vivek Shinde, Novovax, Gaithersburg, USA; Igor Smolenov, PATH, Seattle, USA; Tonya Villafana, MedImmune, Gaithersburg, USA; Niteen Wairagkar, The Bill and Melinda Gates Foundation, Seattle, USA; Myra Widjojoatmodjo, J&J, Leiden, The Netherlands. WHO secretariat: Mohammed Alali, Ahmed Bellah, Maurice Bucagu, Adam Cohen, Kai Gao, Terry Gail Besselaar, Brigitte Giersing, Ivana Knezevic, Drew Meek, Vasee Moorthy, Justin Ortiz, Shamim Qazi, Johan Vekemans, Tiequn Zhou, Patrick Zuber. In particular we would like to thank the following for their review and comments on the manuscript: Louis Bont, Terry Gail Besselaar, Peter Collins, Harish Nair, James Nokes, Eric Pelfrene, Eric A.F. Simoes, Ilse Dieussaert, Pamela Griffin, Deborah Higgins, Ivana Knezevic, Drew Meek, Myra Widjojoatmodjo, Allison August. This meeting was funded by the Bill & Melinda Gates Foundation (Global Health Grant OPP1114766). The views, findings, and conclusions contained within are those of the authors and should not be construed to represent the positions or policies of the Bill & Melinda Gates Foundation, the US Department of Defence or the World Health Organization. Publisher Copyright: {\textcopyright} 2017",
year = "2019",
month = nov,
day = "28",
doi = "10.1016/j.vaccine.2017.02.068",
language = "English (US)",
volume = "37",
pages = "7355--7362",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "50",
}