WHO/Paul-Ehrlich-Institut Informal Consultation on Scientific and Regulatory Considerations on the Stability Evaluation of Vaccines under Controlled Temperature Chain (CTC)

Overview

With the objective of developing regulatory convergence regarding CTC vaccine stability assessments and support programme implementation, WHO in collaboration with Health Canada held a consultation in Ottawa from 4 to 6 December 2012. The workshop was to identify the issues which have to be overcome to develop CTC for vaccines. The participants considered: the design of stability studies required for this type of assessment, appropriate stability indicating assays, the best statistical methods to use for such evaluations, issues related to vaccines under development versus existing vaccines where some data may already exist; and when further clinical studies may be required in specific situations. These issues were further explored and broadened at a meeting held at the Paul Ehrlich Institut (PEI), Langen, Germany from 4 to 6 June 2013.