2014-09-17-世界卫生组织-The_Global_Vaccine_Safety_Initiative_19页_261kb

1. 简介与目标

The Global Vaccine Safety Initiative (GVSI) was launched under the World Health Organization in March 2012 to strengthen vaccine pharmacovigilance systems in low and middle-income countries (LMICs). The initiative aims to establish effective vaccine safety monitoring systems by 2020, improving the detection, assessment, and response to vaccine safety concerns in LMICs.

2. 背景与战略规划

The GVSI is based on the Global Vaccine Safety Blueprint, developed by WHO in collaboration with technical consultants. The three strategic goals of the Blueprint are:

• To assist LMICs in enhancing their capacity for vaccine safety activities.
• To strengthen vaccine safety assessment capabilities in countries introducing new vaccines.
• To establish a global vaccine safety support structure.

3. 组织结构与运作机制

• 规划小组: Composed of external experts who provide advice on the implementation of the Blueprint and oversee the GVSI's work plan and budget.
• 协调机制: The WHO GVSI Secretariat coordinates activities, prioritizes projects, and facilitates international collaboration.
• 活动清单: Activities are categorized into priorities (1 to 3) based on criteria such as impact, geographic relevance, feasibility, and sustainability.

4. 资金与知识产权

• The GVSI does not directly fund activities; participants are responsible for their own funding.
• WHO actively seeks funds to support activities, ensuring minimal competition among participants.
• Intellectual property rights are protected through confidentiality agreements and proper acknowledgment of contributors.

5. 冲突管理

A strict conflict-of-interest policy is enforced, requiring all participants to disclose any potential conflicts. Measures include partial or full exclusion from meetings or tasks where the conflict exists.

6. 公私合作

The GVSI engages in public-private interactions through umbrella organizations of vaccine manufacturers and individual consultants. This collaboration is crucial for improving information exchange and monitoring mechanisms between governments, manufacturers, and regulatory agencies.

7. 实施状态

During its first two years, the GVSI completed several activities, including developing monitoring tools and capacity-building programs. However, funding remains insufficient, and further resource mobilization is critical for full implementation of the Blueprint.

8. 结论

The GVSI is a WHO mechanism for enhancing global vaccine safety through coordinated efforts. Achieving its vision requires sustained financial support, capacity building, and active participation from all stakeholders to ensure equitable vaccine safety standards worldwide.