High quality vaccine safety information in Europe by standardizing methodologies, facilitating data comparability and building collaborative networks
Immunization safety concerns are increasing as the success of immunization systems increases. With a decreasing incidence of disease, public attention shifts towards adverse events following immunization (AEFI). It is then only a matter of time until a concern will be raised and publicized, public confidence will be lost, immunization rates will decrease and a resurgence of disease is likely to follow. Therefore, maintaining the success of immunization programs critically relies on public confidence, which is based on public perception. Public perception depends on the quality of information provided. Information about the safety of immunizations needs to be placed on the most rigorous scientific basis possible, because concerns may lead to withdrawal of the product from the market, modification of the pertinent recommendations, or loss of public confidence.
Need of VAESCO Project
Currently, most European member states monitor the safety of human vaccines. However, the sensitivity and timeliness of vaccine safety monitoring systems, the technical capacity for investigations of vaccine safety concerns and the communication strategies with health professionals and the general public are variable. The lack of common aims and standards is a missed opportunity to make use of valuable resources, significantly improve data comparability across European member states and thus enhance the value of national vaccine safety data.
1. European Collaboration
- To establish a European collaborative network of agencies responsible to collect and collate information on AEFI in Europe
- To facilitate and accelerate the cooperation between the responsible agencies in Europe
- To develop guidelines harmonizing vaccine safety monitoring and causality assessment in Europe
- To build capacity within the field of disease prevention by providing tools, infrastructure and models founded on evidence based practice.
- To develop protocols evaluating current practice and standards in use.
- To evaluate new strategies and methods to optimize integrated vaccine safety asessment
- To raise awareness of the availability, educate about the benefit of use, facilitate access to and monitor use of guidance documents.
- To identify opportunities to facilitate, and harmonize systematic data collection across Member States and their constituent regions.
- To conduct studies evaluating selected adverse event and their relation to immunization(s)
- to promote concerted data collection and employ novel methodologies to pool and analyze data from large linked databases across European member states.
- Altruism: To serve the needs of the global community concerned with immunization safety
- Collaboration: To work together effectively by promoting good internal and external communications through open decision making and teamwork
- European Participation: To promote European participation
- Independence: To keep the VAESCO Project scientifically independent
- Multidisciplinary Approach: To involve people of different skills and backgrounds, in order to benefit and build upon their contributions
- Generalizability: To minimize bias by adhering to a strict scientific approach, ensuring broad participation, and avoiding conflicts of interest
- Relevance: To maintain VAESCO documents up-to-date by identifying and incorporating the highest achievable quality of clinical evidence
- Accessibility of Work: To facilitate access to VAESCO documents through strategic alliances and choice of media
- Responsiveness: To provide quality information by being open and responsive to criticism
- Continuity: To maintain continuity of responsibility for Brighton documents and key functions
- Accessibility: To allow broad participation in the work of the VAESCO Project by minimizing obstacles to contributing and promoting diversity