WHO/Health Canada Drafting Group Meeting on Scientific and Regulatory Considerations on the Stability Evaluation of Vaccines Under Controlled Temperature Chain

On December 4 to 6, 2012, a consultation was held under the auspices of the World Health Organization (WHO) and Health Canada in Ottawa to identify obstacles to further developing a controlled temperature chain for vaccines. As described in this meeting report, the discussion included the design of required stability studies, appropriate stability-indicating assays, the statistical methods best used, considerations for vaccines under development versus existing vaccines where some data may already exist, and where further clinical studies may be required.

Author(s): World Health Organization

Published: 2013