QC, QA & CMC

Safety Assessment of Vaccines against Priority Pathogens: the CEPI Safety Platform for Emergency Vaccines (SPEAC) Project, 2019–2026

Vaccine Insights 2026; 5(3), 167–190

10.18609/vac.2026.024

Published: 2 June
Expert Insight
Eileen C Farnon, Caroline Cassard, Steven Black, Cornelia L Dekker, Wan‑Ting Huang, Barbara Law, Hammad Ali, Shelly T Karuna, Emily Wellman, Marc Gurwith, Esperança Sevene, Andy Stergachis, Hanna Nohynek, Preetha Iyengar, Manu Chaudhary, Clare L Cutland, Dale Nordenberg, Flor Muñoz, Mohammad Gazi Shah Alam, Krutika Kuppalli, Azwi Takalani, María Pía Aristimuño, Ángel Honrado, Adriana Gibby, Sarah Jones, Chiara Corlianó Nahi, Paz Aguirre, Izidora Skračić, Miriam Sturkenboom, Robert T Chen

Initiated in 2019 as a partnership between the Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration, the Safety Platform for Emergency vACcines (SPEAC) project aims to enhance safety assessment of vaccines against epidemic and pandemic threats. SPEAC provides standardized tools and expert guidance to ensure robust, harmonized safety monitoring across CEPI‑funded vaccine clinical trials. SPEAC tools created for CEPI‑funded developers comprise digital toolkits supporting priority pathogens and vaccine platforms, including adverse events of special interest (AESI) lists; AESI case definitions; companion guides; vaccine profiles; and tools for safety assessment in pregnant and pediatric populations. SPEAC’s cross‑cutting support includes a Meta‑Data Safety Monitoring Board overseeing safety across diverse platform technologies and pathogens; dashboards regarding active surveillance in low- and middle‑income countries; and living systematic reviews. SPEAC’s tools, guidance, and their digital transformation facilitate rapid and robust safety assessment of CEPI‑funded vaccines, in support of CEPI’s 100 Days Mission.