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

Research output: Contribution to journalArticle

11 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)7443-7450
Number of pages8
JournalVaccine
Volume37
Issue number50
DOIs
StatePublished - Nov 28 2019

Keywords

  • Vaccine regulation
  • Zika vaccines
  • Zika virus

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Vannice, K. S., Giersing, B. K., Kaslow, D. C., Griffiths, E., Meyer, H., Barrett, A., Durbin, A. P., Wood, D., & Hombach, J. (2019). Meeting Report: WHO consultation on considerations for regulatory expectations of Zika virus vaccines for use during an emergency. Vaccine, 37(50), 7443-7450. https://doi.org/10.1016/j.vaccine.2016.10.034