The Safety Platform for Emergency vACcines(SPEAC) is a project of the Coalition for Epidemic Preparedness Innovations (CEPI) and Brighton Collaboration. SPEAC’s mission is to provide the best available scientific evidence on the safety of CEPI-funded vaccines to support timely benefit-risk assessment during the vaccine lifecycle. SPEAC provides a harmonized vaccine safety assessment and monitoring service for CEPI and its awardees in as many geographic regions where emerging pathogen vaccine studies will be conducted, with a focus on low- and middle-income countries.
Project Background
The Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative global partnership working to accelerate the development of vaccines against epidemic and pandemic threats. Brighton Collaboration is an international community of vaccine safety experts that provides standardized, validated, and objective methods for monitoring vaccine safety profiles and benefit-risk ratios.
In 2019, CEPI and Brighton Collaboration came together and launched the Safety Platform for Emergency vACcines (SPEAC). SPEAC aims to enhance safety for CEPI-funded trials across multiple platforms for multiple pathogens. In its first iteration, SPEAC 1.0 consisted of four work packages designed to enable harmonized evaluation of vaccine safety across CEPI’s portfolio, which includes vaccines for Lassa fever, Nipah virus, MERS, and Chikungunya. Early work focused on developing and piloting processes for Lassa fever which can be adapted to other CEPI priority pathogens and building relationships with CEPI-funded vaccine developers. At the start of the COVID-19 pandemic, SPEAC shifted its focus to supporting Covid-19 vaccine development. This support included the development of an AESI list and the launch of working groups to develop a case definition for post-immunization ED and safety templates for non-viral vector platforms. At the same time, work related to non-COVID-19 pathogens progressed, including tool development and the creation and launch of the Data and Safety Monitoring Board training.
The SPEAC project was renewed in 2022. As part of this project, CEPI is providing up to US$23 million over four years to broaden the scope of the SPEAC programme to deliver world-leading vaccine safety guidance and support for CEPI’s 5-year strategy – known as CEPI 2.0 – and the organization’s 100 Days Mission, which aims to compress the development of new vaccines against pathogens with pandemic potential to just 100 days.
CEPI and Brighton Collaboration launched SPEAC 2.0 in December 2022 to continue its work in DSMB and scientific coordination for Disease/AESI X as well as support outreach to low- and middle-income countries and facilitate rapid response. SPEAC 2.0 now consists of 10 work packages designed to enhance assessment and harmonize monitoring of vaccine safety and provide a continuous improvement framework.
How SPEAC contributes to CEPI’s 100 Days Mission
SPEAC experts and CEPI are working to support developers in efficiently producing vaccines that are as effective and safe as possible. SPEAC supports CEPI in its 100 Days Mission by providing standardized definitions of safety outcomes across pathogen portfolios throughout clinical development and during vaccine use in public health response. SPEAC tools and services support the generation of aggregable and comparable data from which as robust conclusions of safety as possible can be drawn.
SPEAC Goals
SPEAC goals are to prepare, transform, and connect.
1. Prepare: SPEAC provides tools and services for harmonized safety monitoring in vaccine studies by supporting vaccine developers and CEPI-funded clinical trial awardees.
2. Transform: SPEAC harnesses the learnings around safety monitoring of COVID-19 vaccines to improve the efficiency of safety data collection and knowledge sharing.
3. Connect: SPEAC connects vaccine safety experts and partners globally.
