Safety Surveillance Efforts for Vaccines and Therapeutics During Outbreaks and Pandemics

The presentation outlines Africa CDC’s strategic approach to pharmacovigilance (PV) during public health emergencies. It emphasizes the integration of PV into the Africa CDC Strategic Plan (2023–2027), particularly under Priority 2, which focuses on proactive surveillance and early warning systems. The PV unit aims to enhance real-time reporting of adverse events following immunization (AEFI) and adverse events of special interest (AESI), strengthen national PV centers, and build sustainable regional safety surveillance networks. Key emergency activities include safety monitoring of medical countermeasures (MCMs) like Mpox vaccines, capacity building for national regulatory authorities, and harmonization of tools and protocols. The COVID-19 pandemic served as a catalyst for PV system development, prompting digital innovation, increased adverse event reporting, and long-term infrastructure investments. Africa CDC plays a leadership role through regional coordination, partnerships (e.g., with WHO AFRO, AVAREF), and initiatives like AU-3S and Saving Lives & Livelihoods (SLL). Digital tools such as dashboards and mobile apps have enabled real-time monitoring and public engagement. Progress includes operational PV centers in over 35 AU Member States, eight countries reaching WHO Maturity Level 3, and enhanced safety surveillance for vaccines like COVID-19, Mpox, and malaria (RTS,S). However, challenges persist, including underreporting, fragmented data systems, limited workforce, lack of emergency PV protocols, and unsustainable financing. Strategic recommendations include institutionalizing PV in emergency preparedness plans, investing in digital infrastructure, building regional PV workforce pools, and harmonizing regulatory pathways through AMA, AVAREF, and AU-3S. The presentation concludes with a call to action for safeguarding Africa’s health through coordinated, sustainable, and responsive pharmacovigilance systems.