WHO informal consultation on characterization and quality aspect of vaccines based on live viral vectors, December 2003
The objectives of the consultation were to:
- Review the experience with development and evaluation of vaccines based on live viral vectors: adenoviruses, poxviruses;
- Discuss needs for standardization and control of live viral vector vaccines, and
- Consider regulatory concerns and requirements in this area.
The expected outcomes of the Consultation included:
- better understanding of requirements for developing appropriate quality, efficacy and safety testing for full characterization of vaccines based on live viral vectors,
- mapping out requirements for their clinical trial approval and licensure, and
- identifying needs for the development and establishment of appropriate reference materials to improve quality control, as well as efficacy and safety testing.