2009-05-11-世界卫生组织-WHO_Workshop_in_Training_Performance_of_Potency_Testing_and_Lot_Release_of_Human_Papillomavirus_HPV_Vaccines_17页_132kb

Summary of WHO Workshop on HPV Vaccine Potency Testing and Lot Release

Background: This WHO workshop addressed the capacity-building needs of National Control Laboratories (NCLs) for HPV vaccine testing, in response to the increasing global implementation of HPV vaccines. Hosted at NIBSC in the UK from May 11-15, 2009, the event focused on enhancing skills in vaccine licensure and batch release.

Objectives and Activities: The workshop aimed to provide theoretical and practical training on quality control testing, including in vitro potency assays (IVRP) using ELISA, protocol review, assay validation, and introduction to novel adjuvants. It featured hands-on laboratory sessions, data analysis with CombiStats software, mock protocol reviews, and tours of NIBSC facilities.

Key Findings and Challenges: Participants identified major challenges such as dependence on manufacturers for critical reagents (e.g., antibodies), lack of an international HPV vaccine reference standard, unavailability of SOPs and assay methodologies, human resource shortages, and logistical issues like cold chain problems. During discussions, issues with cost, frequency of lot release, and harmonization of global standards were highlighted.

Outcomes and Recommendations: Training was deemed highly effective by participants, with recommendations for ongoing WHO technical support. Suggestions included developing strategies to reduce reliance on manufacturers by providing international standards and addressing specific needs like adjuvant testing to strengthen global vaccine regulation and quality assurance efforts.