In 2019, CEPI entered into a partnership with the Brighton Collaboration under the Taskforce for Global Health, to provide additional expertise and resources for the management of vaccine safety data across CEPI-funded programs.
1. The Definition of SPEAC
SPEAC (Safety Platform for Emergency vACcines) is an international collaborative project of the Brighton Collaboration (BC) funded by the Coalition for Epidemic Preparedness Innovations (CEPI). SPEAC aims to harmonize the safety assessment of vaccine candidates in CEPI funded clinical trials across pathogens and platforms to maximize the ability to interpret such evidence.
2. Background of SPEAC
CEPI’s mission is to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks. To achieve its mission, CEPI is supporting the development of a wide range of vaccine candidates and platform technologies against prioritized target pathogens.
The Brighton Collaboration is an organization of volunteers with the vision of building trust in the safety of vaccines through rigorous science. BC facilitates the development, evaluation and dissemination of high-quality information about the safety of human vaccines by assembling and coordinating expert working groups that create case definitions and standards for safety data collection. The Brighton Collaboration has already a toolbox with 58 standardized case definitions, matrices for data collection on vaccine safety in clinical trials and during maternal immunization, as well as viral vector vaccine templates.
In 2019, CEPI partnered with the Brighton Collaboration by funding the SPEAC project through the Task Force for Global Health (TFGH). The TFGH prevents, protects, and eliminates diseases affecting vulnerable populations in more than 150 countries. Its 15 programs focus on developing and implementing strategies to increase access to vaccines and to expand the capacity of countries to deliver the vaccines, eliminating blinding and disfiguring diseases and building public health infrastructure to ensure countries can protect their populations against diseases and other health threats. The Task Force uses a powerful collaborative model to leverage resources and expertise to address large-scale health problems.
SPEAC aims to support the development of the CEPI vaccine portfolio by providing capacity and solutions for harmonized safety assessment of CEPI funded vaccine development. The CEPI-funded portfolio includes multiple vaccine constructs, which are being used to develop vaccines against multiple pathogens. As part of the SPEAC project, the Brighton Collaboration will provide the following services:
- Provision of a pool of vaccine safety experts that may take part in the independent Data Safety Monitoring Boards (DSMB).
- Implementation of a meta-DSMB, a group of vaccine safety experts who will monitor safety issues across clinical trials, platforms and individual vaccines.
- Developing new case definitions anddecision trees for data collection for use by developers, as well as guidance for harmonized data collection.
- Provision of landscape analyses on rates of disease and spontaneous reports, as well as to support the DSMB members.
- Evaluation of the acceptability of the standards and tools developed by SPEAC.
4. Planned activities/Scope
- Safety monitoring: this includes 1- creation of a large pool of vaccine safety trained DSMB members in target countries to support developers’ study DSMBs; and 2- constitution and operation of a meta-DSMB group of experts that will liaise with study DSMBs as observers across the different trials, and will advise CEPI on any potential safety issues across different products, target pathogens and/or platforms.
- Toolbox: creation of tools for the developers (case definitions, templates, checklists, prioritized events of interest, landscape analysis on reported events and background rates) and standards (data collection matrices) to facilitate monitoring of safety in CEPI funded vaccines.
- Evaluation: quality assurance and continuous improvement of SPEAC outputs and its overall impact.
- Coordination & communication: project coordination and interaction with stakeholders (developers, regulators, CEPI, scientific community).
5. Working with consortia
To achieve its objectives, SPEAC is networking and collaborating with different partners with different expertise. These include the members of CEPI, Brighton Collaboration and TFGH; but also different vaccine developer institutions (pharmaceutical companies, universities, other consortia, etc.).
6. Communication strategy with the partners and the public
One of the key objectives of SPEAC is the communication and dissemination of all the generated information, documents, tools, etc. This communication is not limited to SPEAC partners. Most of SPEAC’s work will be also disseminated to the public through the Brighton Collaboration website. Additionally, SPEAC members regularly attend conferences and workshops worldwide to share the platform’s main achievements with the scientific community.
Further information on the Brighton Collaboration can be found here.
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