Meeting Report: WHO consultation on considerations for regulatory expectations of Zika virus vaccines for use during an emergency

K S Vannice; B K Giersing; D C Kaslow; E Griffiths; H Meyer; A Barrett; A P Durbin; D Wood; J Hombach

doi:10.1016/j.vaccine.2016.10.034

Meeting Report: WHO consultation on considerations for regulatory expectations of Zika virus vaccines for use during an emergency

Vaccine. 2019 Nov 28;37(50):7443-7450. doi: 10.1016/j.vaccine.2016.10.034. Epub 2016 Dec 20.

Authors

K S Vannice¹, B K Giersing¹, D C Kaslow², E Griffiths³, H Meyer⁴, A Barrett⁵, A P Durbin⁶, D Wood⁷, J Hombach⁸

Affiliations

¹ Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland.
² PATH, Seattle, WA 98109, USA.
³ The Farthings, Kingston Upon Thames, Surrey KT2 7PT, UK.
⁴ Paul-Ehrlich-Institut, Langen 63225, Germany.
⁵ 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.
⁶ Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
⁷ Department of Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.
⁸ Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva 27, Switzerland. Electronic address: hombachj@who.int.

PMID: 27916410
DOI: 10.1016/j.vaccine.2016.10.034

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.

Keywords: Vaccine regulation; Zika vaccines; Zika virus.

Publication types

Review

MeSH terms

Animals
Disease Outbreaks / prevention & control*
Emergencies
Humans
Public Health / methods
Referral and Consultation
Viral Vaccines / immunology*
World Health Organization
Zika Virus / immunology*
Zika Virus Infection / immunology*

Substances

Viral Vaccines