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.
journal_name
Vaccinejournal_title
Vaccineauthors
Vannice KS,Giersing BK,Kaslow DC,Griffiths E,Meyer H,Barrett A,Durbin AP,Wood D,Hombach Jdoi
10.1016/j.vaccine.2016.10.034subject
Has Abstractpub_date
2019-11-28 00:00:00pages
7443-7450issue
50eissn
0264-410Xissn
1873-2518pii
S0264-410X(16)30969-0journal_volume
37pub_type
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