title: Meeting Report: WHO consultation on considerations for regulatory expectations of Zika virus vaccines for use during an emergency.
abstract: On 1 February 2016, in the context of the ongoing Zika virus epidemic, the WHO declared that the recently reported clusters of microcephaly and other neurological disorders constituted a Public Health Emergency of International Concern (PHEIC). In response, WHO in collaboration with UNICEF and a working group of independent subject matter experts developed a Zika virus vaccine Target Product Profile (TPP) for use in an emergency, or in a future outbreak scenario. The drafting process of the Zika virus vaccine TPP included the opportunity for public comment, as well as consultation with epidemiologists, flavivirus vaccine subject matter experts, vaccine developers and global regulators to consider the regulatory expectations and potential emergency use pathways for a vaccine with the characteristics described in the TPP. This report summarizes an expert consultation held 6-7 June 2016 on the regulatory considerations for a Zika vaccine for emergency use.
authors.affiliation: Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland.
authors.forename: K S
authors.initials: KS
authors.lastname: Vannice
authors.affiliation: Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland.
authors.forename: B K
authors.initials: BK
authors.lastname: Giersing
authors.affiliation: PATH, Seattle, WA 98109, USA.
authors.forename: D C
authors.initials: DC
authors.lastname: Kaslow
authors.affiliation: The Farthings, Kingston Upon Thames, Surrey KT2 7PT, UK.
authors.forename: E
authors.initials: E
authors.lastname: Griffiths
authors.affiliation: Paul-Ehrlich-Institut, Langen 63225, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Meyer
authors.affiliation: Sealy Center for Vaccine Development and World Health Organization Collaborating Center for Vaccine Research, Evaluation and Training for Emerging Infectious Diseases, University of Texas Medical Branch, Galveston, TX 77555, USA.
authors.forename: A
authors.initials: A
authors.lastname: Barrett
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
authors.forename: A P
authors.initials: AP
authors.lastname: Durbin
authors.affiliation: Department of Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Wood
authors.affiliation: Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland. Electronic address: hombachj@who.int.
authors.forename: J
authors.initials: J
authors.lastname: Hombach
mesh_terms: D000818:Animals; D004196:Disease Outbreaks / Q000517:prevention & control*; D004630:Emergencies; D006801:Humans; D011634:Public Health / Q000379:methods; D012017:Referral and Consultation; D014765:Viral Vaccines / Q000276:immunology*; D014944:World Health Organization; D000071244:Zika Virus / Q000276:immunology*; D000071243:Zika Virus Infection / Q000276:immunology*
chemical_list: D014765:Viral Vaccines
keywords: Vaccine regulation; Zika vaccines; Zika virus