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Implementation
The International Implementation Working Group
With more vaccines available and accessible around the world, globalization of vaccine safety efforts has become increasingly important. With a basic set of 20+ published Brighton Collaboration case definitions of Adverse Events Following Immunization (AEFI), new working groups continue to emerge steadily. While the generation of case definitions is a remarkable step in the creation of an international vaccine safety terminology, this common language will need to be used and “spoken” in order to be effective in improving vaccine safety around the world.
To achieve the goal of global implementation of vaccine safety standards, a specific action plan
was developed in 2006 by the Brighton Collaboration Secretariat with guidance from the
Steering Committee. The major action taken to increase developing country participation was
the creation of the Implementation Working Group, which will specifically target developing country issues and concerns. The goal of this group is to facilitate the use of Brighton Collaboration AEFI definitions around the world. The concept of this Working Group is fairly simple: There are approved and evidence-based standards available; there are people willing to use them, and others who can help and counsel in the process. Bringing these people to one table will be the next logical step to the implementation of vaccine safety standards globally.
Simultaneous with the recruitment process, a comprehensive literature review has been conducted resulting in an EndNote Database of more than 400 relevant articles. A systematic analysis of these publications is currently underway. In analogy with the work process of “traditional” Brighton Working Groups (creating AEFI case definitions), a systematic literature inventory was presented to the Implementation Working Group with the second conference call, along with a draft review paper on “Challenges and
Opportunities in the Implementation of Vaccine Safety Standards in Developing Countries” to be
finalized after review and discussion with the working group. This first consensus document of the newly formed working group will be ready for submission in 2008.
Objectives for the Working Group
Goal
To facilitate the implementation of Brighton Collaboration vaccine safety standards globally.
Objectives
• To identify challenges in the implementation of vaccine safety standards globally.
• To generate immediate “user-feedback” for the improvement of Brighton Collaboration standards.
• To identify opportunities to facilitate usage of Brighton Collaboration standards in resource-poor settings.
• To generate well-defined implementation proposals and partnerships.
• To identify short term projects for consultancy services in collaboration with international agencies, academic centers, donors and regulators.
Rationale
The Implementation Working Group will provide a forum of clinical researchers, regulatory and donor agencies to discuss how to facilitate the implementation of vaccine safety standards globally. It will act as a “Think Tank” generating new concepts for the harmonization of evidence-based standards in AEFI surveillance in industrialized and nonindustrialized countries and provide consultation and feedback to the Brighton
Collaboration on a regular basis. In addition, a consultancy service will be designed to assist interested personnel in non-industrialized countries in the design and conduct of vaccine safety studies, promoting comparability and high quality evidence-based research.
Working Group Composition
The Brighton Collaboration Implementation Working Group will include well-published experts in international vaccine trials and organizational leaders in their respective countries. The Group will aim for active participation from non-industrialized countries of at least 50%. The Implementation Working Group will be open to organizations conducting centralized harmonization efforts with state health institutions and regulatory authorities
(such as WHO, CIOMS, ECDTP; etc) as well as donor agencies and/or NGOs involved in immunization programs and vaccine trials/ surveillance in developing countries.
Process
Think Tank. Limited time commitment with monthly conference calls.
Outcome
• Increased awareness of Brighton Collaboration standards among the WG participants and stakeholders in international vaccine development and surveillance.
• Improved applicability and “user-friendliness” of Brighton Collaboration case definitions, data collection guidelines, and tools.
• Improved implementation of Brighton Collaboration case definitions in resource-poor settings.
• Improved collaboration with partner networks and organizations involved in international vaccine safety.
• Regular feedback to the Brighton Collaboration.
Work Plan for the Working Group
To accommodate all working group members and the many different time zones optimally, two
parallel calls are held each month. The call agenda and materials are distributed prior to each call. Each month, different topics are chosen to allow focused work and rapid progress in accordance with the group’s objectives. Detailed call minutes are shared with the group after each teleconference. Those unable to attend a call provide their feedback via email in-between calls.
Call Topics to Date:
May - Introduction to the Working Group
June - Discussion and Approval of the WG Objectives
July - Presentation of the Literature Review Draft Manuscript
August - Finalization of the Manuscript
September - Special Topic: Risk communication and the Media - communicating vaccine safety with the general public
October - Conclusions from the Focus call in September - Working Group Recommendations for the improvement of risk communication
November - Special Topic: Technology Transfer – Measures to improve AEFI surveillance systems
December - TBA
Co-Leaders for the Working Group:
Barbara A. Rath, MD and Alex N. O. Dodoo, PhD, MPSGH, MRPharmS.
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