Brighton Collaboration

The Brighton Collaboration

Service Mark of the Brighton Collaboration Foundation
Formation	2000 (2000)
Type	NPO
Headquarters	Basel, Switzerland
Region served	Worldwide
Official language	English
Leader	Jan Bonhoeffer, president
Website	www.brightoncollaboration.org

The Brighton Collaboration (BC), named after the city in England where the idea was first formulated, is an independent global vaccine safety research network for health care professionals. It is a non-profit partnership providing high-quality vaccine safety information.

The Brighton Collaboration was launched in 2000 as a voluntary international organization to facilitate the development, evaluation, and dissemination of high quality information about the safety of human vaccines. The idea of the collaboration started in 1999, following a presentation by Bob Chen at an international scientific vaccine conference in Brighton, U.K.. In his talk, he stressed the need to improve vaccine safety monitoring by developing internationally accepted standards.^[1] Among the members of the audience were Harald Heijbel, Ulrich Heininger, Tom Jefferson, and Elisabeth Loupi who approached Bob Chen after his presentation. The 5 of them decided to start the project to develop a common language and standardized research methodology to improve the accuracy of vaccine safety risk assessment modeled after the Cochrane Collaboration for evidence-based medicine

Background

National and regional immunization coverage and the total numbers of vaccines administered is growing in all countries. Hundreds of millions of children and adolescents have been immunized globally.^[2] The coming decade will be one of the most productive in the history of vaccine development.^[3] In countries with mature immunization programs, infection rates have fallen by 99%.^[4] The global collaborative effort to implement immunization programs is estimated to save 2-3 millions of deaths each year.^[5]

With the increase of vaccines around the world, there is an increased responsibility to carefully monitor and investigate their safety.^[6][7] Today, vaccine safety concerns happen in all areas of the globe. When these concerns go unaddressed, whether they are well founded or not, they can have devastating consequences for immunization programs, and thus the lives of millions. If there is a real safety issue with a vaccine given to healthy individuals, identification, communication, as well as a timely and reliable public health response and regulatory action is the collective ethical mandate. For a global immunization program to be successful and sustainable, concerted safety monitoring must develop alongside of it.

Global vaccine safety research network

The BC is an independent global vaccine safety research network for health care professionals. It is a non-profit partnership providing high-quality vaccine safety information. It does not advocate for specific vaccines and does not receive funding from specific manufacturers. Its foundation is a Swiss registered public charity with international scope.

Mission

To enhance the science of vaccine research by providing standardized, validated, and objective methods for continuous monitoring of safety profiles and by assessing benefit-risk ratios. These methods are, in turn, recognized and recommended for use by international regulatory and public health agencies.^[8]

Areas of activity

The Collaboration focuses on 5 areas:

1. SETTING STANDARDS Scientific Advisors: Jim Buttery, Murdoch Children‘s Research Institute, Melbourne, AUS Barbara J. Law, Centre for Immunization and Respiratory Infectious Diseases, Public Health Agency of Canada, Ontario, CAN Highly variable methodology in previous vaccine studies made valid comparison of vaccine safety profiles difficult, if not impossible. Researchers often used different definitions for adverse events following immunization (AEFI) such as «fever», «encephalitis» and many other AEFI. Thus the significance of reported higher or lower AEFI rates after different vaccines or between trials of the same vaccine conducted at different research centers was difficult to interpret. Variable case definitions of AEFI also made valid quantification of rare but serious AEFI nearly impossible. Brighton Collaboration has addressed these issues by using its expert network, via web platforms and teleconferences, to develop standardized and validated AEFI case definitions. These are published on the web and in the journal Vaccine. In addition to this ongoing effort, working groups have developed standardized protocols for safety aspects of vaccine clinical trials and/or post-marketing surveillance. Further, a web tool, making possible accurate, rapid and standardized reporting and classification of AEFI according to the standardized case definitions has been developed. This requires only a few minutes to complete per case and thus promotes efficiency for reporters and investigators. Protocols for data analysis and reporting have also been developed.

2. CLINICAL ASSESSMENT Scientific Advisors: Kathryn M. Edwards, Vanderbilt University School of Medicine, Nashville, Tennessee, USA Michael S. Gold, Women’s and Children’s Health Network, Adelaide, AUS For individuals with adverse events following immunization (AEFI), thorough assessment of their condition is paramount, not only for the management of the respective event, but also to ascertain if the event was related causally to immunization. If the event was caused by the vaccine it is increasingly important to advance the science of understanding the mechanism of such reactions. At the Brighton Collaboration we leverage a network of international experts to assist globally in exchanging information on such events and to help advance vaccine safety science and identify potentially causally related versus merely temporally related AEFI.

3. DATA LINKAGE Scientific Advisors: Steve Black, Cincinnati Children‘s Hospital Medical Center, Cincinnati, USA Miriam Sturkenboom, Erasmus University Medical Center Rotterdam, Rotterdam, NED Serious adverse events following immunization causally related to licensed vaccines are usually rare (<1:100,000). However, they become relatively prominent when millions of healthy people are vaccinated and the target disease disappears. Their reliable detection and evaluation is important to provide the best care. The rarity of such events makes detection and analysis possible only through linkage of large digital databases across countries. Brighton Collaboration partners have made this a working reality.

4. CAPACITY BUILDING Scientific Advisors: Hector Izurieta, EPI, World Health Organization, Geneva, CH Egeruan Babatunde Imoukhuede, Jenner Institute, University of Oxford, Oxford UK Expertise, state of the art scientific methods and competent infrastructures need to be developed to meet global needs, particularly in the developing world. This requires training in vaccine safety monitoring, methodology, data management, and public communications. Brighton Collaboration is developing such materials for use in the developing world.

5. PUBLIC CONFIDENCE Scientific Advisors: Heidi Larson, Senior Lecturer and Director, London School of Hygiene and Tropical Medicine, London, UK Daniel Salmon BA, Associate Professor, Johns Hopkins Bloomberg School of Public Health, Baltimore USA The importance of public confidence in vaccines is well established. Vaccine «scares» prompted by rumors, sensationalized media reports or flawed studies published in the scientific literature, have demonstrated that public mistrust of vaccine safety can seriously derail effective vaccination programs. Prompt investigation and management of adverse events following immunization (AEFI) minimizes public anxiety. The Brighton Collaboration is promoting research on the determinants of trust and distrust in vaccines generally as well as on the drivers of vaccine «scares», the manner in which they develop and spread, and effective strategies to best address vaccine safety concerns.

References

External links

• Official website