Overview

Efficacy data from placebo-controlled clinical trials are used to support vaccine authorization, when feasible. However, sometimes randomized, controlled trials are not feasible, due to the sporadic nature of outbreaks. In these cases, use of an alternative strategy, such as a Correlate or Surrogate of Protection to infer vaccine effectiveness in combination with Real World Evidence may be needed to support vaccine use, if the expected benefits outweigh the risks.

All vaccines have risks associated with them and it can be unclear to stakeholders at which point the benefits of using vaccines outweigh the risks. Use of a standardized tool will help define the breaking points between benefits and risks in the development process. 

SPEAC is a project resulting from the partnership between the Coalition for Epidemic Preparedness Innovations (CEPI) and Brighton Collaboration. SPEAC provides vaccine safety tools, resources, and expertise throughout the vaccine development process to enhance safety and build confidence in vaccines.

The primary goal of SPEAC is to build trust in the safety of vaccines through rigorous scientific methods. Unlike efficacy, which can be measured directly, vaccine safety is inferred from the relative absence of multiple adverse events following immunization (AEFI). SPEAC addresses this by developing internationally accepted standards for monitoring vaccine safety throughout the vaccine lifecycle.

Key components of SPEAC include:

• Developing and harmonizing safety monitoring standards for vaccines during preclinical and clinical trials.

• Providing guidance for the collection and reporting of vaccine safety data.

• Creating a continuous improvement framework for vaccine safety assessment.