- All > Quality and Safety: Medicines > Blood Products and Related Biologicals
- All > Quality and Safety: Medicines > Quality Assurance
- Keywords > biological standardization
- Keywords > biologicals - manufacture and quality control
- Keywords > blood products and related biologicals - quality assurance and safety
- Keywords > ebola vaccines - quality, safety and efficacy
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > guidelines and standards
- Keywords > quality assurance
- Keywords > vaccines - production and control
- Keywords > vaccines and related substances
(2018; 93 pages)
This document provides information and guidance on the development, production, quality control and evaluation of candidate Ebola vaccines in the form of WHO Guidelines rather than WHO Recommendations. This allows for greater flexibility with respect to the expected future of Ebola vaccine development, production, quality control and evaluation. Given that this is a very dynamic field both in terms of technologies and clinical trial designs, these WHO Guidelines should be read in conjunction with other relevant recent guidelines.
A model protocol for the manufacturing and control of viral-vectored Ebola vaccines is provided in Appendix 1 of these WHO Guidelines. This protocol outlines the information that should be provided as a minimum by a manufacturer to the NRA in support of a request for the release of a vaccine for use. The protocol is not intended to apply to material intended for clinical trials. A Lot Release Certificate signed by the appropriate NRA official should be provided if requested by a manufacturer, and should certify whether or not the lot of vaccine in question meets all national requirements and/or Part A of these WHO Guidelines. The purpose of this is to facilitate the exchange of vaccines between countries, and should be provided to importers of the vaccines. A model NRA Lot Release Certificate is provided in Appendix 2.
These WHO Guidelines provide scientific and regulatory guidance for national regulatory authorities (NRAs) and vaccine manufacturers on the quality, nonclinical and clinical aspects of Ebola vaccines relevant to marketing authorizations. In particular, the document deals with Ebola vaccines based on viral vectors, which are currently at the most advanced stage of development and for which no specific WHO guidance is available. The document also discusses opportunities to accelerate vaccine development and product availability during a public health emergency. The document does not address access programmes or regulatory pathways for making investigational Ebola vaccines available for situations where their use is not primarily intended to obtain safety and efficacy or effectiveness information.