Intro -- _Hlk79082372 -- Acknowledgments -- Abbreviations and acronyms -- Prologue -- Moving from a minimal and enhanced capacity concept to maturity levels -- Governance and systems development -- Introduction -- Governance -- Rationale -- Objective: provide the structure for effective decision-making in support of vaccine safety -- System funding and financing -- Rationale -- Objectives -- Objective 1: Encourage provision of adequate resources for the operations undertaken by public vaccine safety systems -- Objective 2: Describe public vaccine safety funding options appropriate for the maturity level of the regulatory system in a country -- Objective 3: Address injuries caused by vaccine reactions or vaccination errors -- Coordination of safety systems -- Introduction -- Rationale -- Objectives -- Objective 1: Coordination for exchange of information between vaccine manufacturers (or marketing authorization holders) and national regulatory authorities at local, regional and global levels -- Objective 2: Coordination and information exchange between health authorities and other stakeholders at each level -- Objective 3: Coordination and exchange of information between health authorities and advisory bodies at local, regional and global levels -- Objective 4: Collaboration between the scientific community and health authorities -- Objective 5: Communication between health authorities and the populations they serve -- Regulatory framework -- Introduction -- Rationale -- Objectives -- Objective 1: All countries should have provisions to establish vaccine pharmacovigilance, including laws, regulations, infrastructure, and lines of accountability -- Objective 2: Ensure vaccine pharmacovigilance is a national, regional, and international responsibility -- Objective 3: Develop human resources to perform regulatory safety surveillance activities.

Surveillance of adverse events following immunization (AEFI) -- Introduction -- Rationale -- Objectives -- Objective 1: Detect and assess vaccine safety signals that warrant further investigation -- Objective 2: Investigation of AEFIs -- Objective 3: Conduct individual and population level AEFI causality assessment -- Objective 4: Prevent vaccination adverse reactions -- Objective 5: Strengthened capacity to address vaccine-related adverse events and communication response -- Enhanced vaccine safety communication -- Introduction -- Rationale -- Objectives -- Objective 1: Strengthen the capacity and infrastructure to communicate vaccine safety information and manage the communication response to vaccine safety related events -- Objective 2: Identify and characterize vaccine safety concerns among the public, healthcare workers and other stakeholders as potential safety signals that warrant further investigation and a communication response -- Objective 3: In a crisis, provide timely, short and clear messages to all stakeholders describing what is known, what is not known, and what is being done to fill these gaps -- Fragile states and emergencies -- Introduction -- Rationale -- Objectives -- Objective 1: Use vaccine safety monitoring as a quality assurance mechanism for vaccination activities in fragile states and in emergency situations -- Objective 2: Monitor the safety of novel vaccines for emerging infectious diseases during emergencies -- Accountability framework -- Rationale -- GVSB1.0: minimal and enhanced capacity -- Current WHO Benchmarking Tool sub-indicators of maturity levels -- Objectives and strategies for each strategic area -- References -- _GoBack.