Brighton Collaboration is a community aiming to promote and improve vaccine safety.
The success of vaccines brings the responsibility to ensure that immunisations remain as safe as possible, particularly since they are given to healthy individuals. Vaccines are now distributed faster and to wider populations than ever before. Reliable safety information must be available rapidly on a similar scale so that vaccine recipients and decision makers can evaluate vaccine benefits and risks accurately. We are committed to address this need. We improve health through vaccine safety and rigorous science.
The Collaboration Abides by the Following Principles:
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.
Worldwide Participation – To promote global participation.
Independence – To keep the Brighton Collaboration 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 Brighton documents up-to-date by identifying and incorporating the highest achievable quality of clinical evidence.
Accessibility of Work – To facilitate access to Brighton documents through strategic alliances and choice of media.
Responsiveness –To provide high 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 Brighton Collaboration by minimizing obstacles to contributing and promoting diversity.
Everything we do is for the purpose of providing vaccine stakeholders with the best possible information so they can make the best possible decisions.
1. Setting Standards
Highly variable methodologies in previous vaccine studies made a valid comparison of vaccine safety profiles difficult, if not impossible. Variable case deﬁnitions of AEFI make valid quantification of rare but serious AEFI nearly impossible.
Improving Data Quality Through Harmonization
Our case deﬁnitions, guidelines and protocols intend to enhance data comparability within and across clinical trials, surveillance systems, and post-licensure clinical studies. Most of our publications can be found in the journal Vaccine or in the Academy.
2. Clinical Assessment
For individuals with adverse events following immunization (AEFI), the thorough assessment of their condition is paramount. For the responsible expert it is essential to ascertain if the event is related causally to immunization.
Improving Individual Case Management
When it comes to AEFI, rapid response is required. We leverage the community s expertise for rapid information exchange. Thus, professionals all over the world can receive state of the art advice in short time.
3. Data Sharing
Serious adverse events following immunization causally related to licensed vaccines are usually rare (<1:100,000). The rarity of such events makes detection and risk analysis challenging.
Improving Risk Assessment
Large data sets are required to estimate the risk of adverse events. We promote the conduct of international collaborative observational studies.
4. Public Confidence
Vaccine scares prompted by rumors have demonstrated that public mistrust may unduly derail immunization programs.
Promoting the Understanding of Public Concerns
Public concerns need to be addressed immediately. We harmonize and develop new methods for public and social media monitoring and share information about emerging rumors.
5. Capacity Building
Expertise, state of the art scientiﬁc methods and competent infrastructures have to be provided in particularly in the developing world.
Building a Network of Excellence
We enhance local vaccine safety expertise through collaborative projects and knowledge transfer.
Our Workflow of Developing Case Definitions and Complementary Guidelines
International consensus is achieved through a global network of individuals and organizations concerned with immunization safety or with associated medical and methodological aspects. The resulting accrual of expertise and the sharing of knowledge within and outside the Collaboration along with the availability of case definitions and guidelines will lead to data comparability. This will benefit vaccine recipients, scientists, health officials and healthcare providers, who need to obtain, interpret, provide, and report information on immunization safety and make scientifically sound decisions.
For each defined adverse event following immunization (AEFI) a document is developed including four sections:
- A preamble to highlight the rationale for essential decisions made and to briefly describe the methodology of how working groups arrived at a particular Brighton document.
- The case definition itself, which is structured in a three-level format taking into account current scientific evidence and different levels of resources available in different research and geographic settings.
- Guidelines for data collection, analysis, and presentation of a given AEFI.
- References for selected points discussed in the preamble.
Step-By-Step: Developing Case Definitions and Complementary Guidelines
Selection of Topic
Based on severity, frequency of reporting, enhanced public interest and emerging scientific needs.
Call for Volunteers
Composition of Groups
Announcement on our website, contacting of pertinent scientific authors and request for referrals.
Based on the balanced composition of professional expertise and geographical location.
Systematic search and compilation of relevant published and unpublished evidence.
Evaluation of inventory through discussions by the Working Group.
|A draft document is developed based on the exploratory|
review and group consensus.
Call for Reviewers
|Announcement on our website, contacting of pertinent scientific authors and request for referrals.|
An online survey guides structured review of the draft document to stimulate critical review.
Survey data are compiled and discussed by the Working Group.
The draft is revised based on Reference Group comments.
The final document is harmonized with other case definition documents.
|Case definition documents are revised in 3-5 year intervals or upon the availability of new scientific information or critical feedback from evaluation and implementation of documents.|