Recommendations to assure the quality, safety and 6 efficacy of Enterovirus 71 vaccines (inactivated)
Proposed new recommendations 8
(Draft-version public consultation)
This document has been prepared for the purpose of inviting comments and suggestions on the proposals contained therein, which will then be considered by the Expert Committee on Biological Standardization (ECBS). Publication of this early draft is to provide information about the proposed WHO Recommendations to assure the quality, safety and efficacy of Enterovirus 71 vaccines (inactivated) to a broad audience and to improve transparency of the consultation process.
These Recommendations were developed based on the outcomes and consensus of the WHO working group meeting convened in 2018 with participants from national regulatory authorities, national control laboratories, vaccine manufacturers and academia researchers. The text in its present form does not necessarily represent an agreed formulation of the Expert Committee. Written comments proposing modifications to this text MUST be received by 28 May 2020 in the Comment Form available separately and should be addressed to the World Health Organization, 1211 Geneva 27, Switzerland, attention: Department of Health Products Policy and Standards. Comments may also be submitted electronically to the Responsible Officer: Dr Dianliang Lei at email: leid@who.int.
The outcome of the deliberations of the Expert Committee will be published in the WHO Technical Report Series. The final agreed formulation of the document will be edited to be in conformity with the "WHO style guide, second edition" (KMS/WHP/13.1).