WHO Workshop in Training Performance of Potency Testing and Lot Release of Human Papillomavirus (HPV) Vaccines

Overview

In light of recent World Health Organization (WHO) recommendations on HPV vaccination (1), it's envisaged that HPV vaccine introduction will be implemented in countries worldwide. The capacity of National Control Laboratories (NCLs) in testing HPV vaccines is a crucial part of the process for vaccine licensure and regulation. Because different methodologies are being used for testing currently available HPV vaccines, the need for WHO technical support has been identified by many NCLs, particularly those in developing countries. In respond to this need, WHO organized a “Workshop in Training Performance of Potency Testing and Lot Release of HPV Vaccines” at the National Institute for Biological Standards & Control (NIBSC), UK, 11-15 May 2009 . Training on the theoretical knowledge and practical performance of HPV vaccine testing and batch release was provided to the participants. This workshop was acknowledged by the participants to be helpful in improving or reinforcing their skills in the testing and release of HPV vaccines. Challenges and further needs of the NCLs were identified during the workshop. These included a dependence of the NCLs on the manufacturers for the supply of product-specific critical reagents such as antibodies and reference vaccines, a situation that is not unique to HPV vaccines. Additional challenges identified included the unavailability of an international reference HPV vaccine, assay methodologies, SOPs, assay equipment and human resources in particular with regard to some new techniques of quality control testing, e.g. assay of novel adjuvants. The participants recommended that WHO provide ongoing technical support to NCLs so that they can continue to build upon that learned at the workshop and strengthen their capacity for HPV vaccine testing.