2006-07-19-世界卫生组织-WHO_Working_Group_meetings_on_revision_of_the_Manual_laboratory_methods_for_testing_DTP_vaccines_19页_217kb

WHO Working Group Meetings on Revision of DTP Vaccine Testing Manual

Objectives and Background

• The meetings (2006 and 2007) aimed to revise the WHO Manual of Laboratory Methods for testing diphtheria-tetanus-pertussis (DTP) vaccines, focusing on reviewing current potency, safety, and identity test methods.
• Context includes global DTP immunization coverage (78% average) and WHO's Global Immunization Vision and Strategy (GIVS) to improve vaccine quality and introduce new vaccines.
• WHO emphasized the need for integrated strategies involving various departments for vaccine standards and safety.

First Meeting (2006, Geneva)

• Key Outcomes: Reviewed existing test methods for D, T, and wP vaccines; surveyed global lab practices; proposed a drafting group for manual revision.
• Method Discussions: Identified critical methods for safety, efficacy, and quality; surveyed 12 labs' usage of tests like potency assays (e.g., mouse weight gain) and statistical analysis; recommended validating alternatives and standardizing procedures.
• WHO Role: Discussed biological standardization, reference materials, and the importance of animal testing reduction (3Rs); outlined future revisions for ECBS and alignment with global strategies.

Second Meeting (2007, Geneva)

• Key Outcomes: Reviewed drafts from first meeting; approved separating DTP testing from viral vaccine testing in the manual; refined proposed outline and statistical methods.
• Manual Structure: Agreed on a manual outline with chapters on introduction, DTP testing (potency, safety, identity), statistical analysis, and other topics like assay validation. Decisions included focusing on quantitative assays, clarifying role of guinea pig tests, and updating guidelines for combined vaccines.
• Collaboration: Drafting groups established for specific sections; emphasized ongoing development and external review by mid-2007.

Proposed Manual Outline

• Chapters:
  • General introduction (scope, validation, statistics).
  • Testing for diphtheria, tetanus, and pertussis vaccines (potency, toxicity, identity, antigen content).
  • Statistical analysis (probit, parallel line assays; design and interpretation).
• Key Elements: Includes invalidated methods (e.g., passive haemagglutination); highlights use of reference materials and alternative approaches; provides guidance for resource-limited labs; incorporates safety and regulatory updates.

Recommendations and Next Steps

• The revised manual will complement WHO recommendations, support quality control globally, and address evolving vaccine formulations.
• Amended drafts to be finalized by 2008; further input required for external review and implementation.