1. BACKGROUND
Africa Centers for Disease Control and Prevention (Africa CDC) is an autonomous technical institution of the African Union that supports the Member States (MS) in planning, preparing, and responding effectively and efficiently to the continent’s public
health threats and outbreaks. Leadership principles of credibility, ownership, delegated authority, timely dissemination of information, transparency, accountability, and value addition guide Africa CDC.
Africa faces a growing demand for robust systems to monitor the safety of medical products, including vaccines, medicines, and medical devices. The diverse regulatory landscapes across African countries and varied practices and tools for generating safety evidence pose challenges to effective pharmacovigilance and post-market surveillance.
Recognizing these challenges, Africa CDC seeks to harmonize tools, protocols, and practices for generating safety evidence. This effort will involve synthesizing existing frameworks, guidelines, and best practices to create a unified vaccine safety assessment and surveillance approach. Key strategies, such as standardized protocols, cross-border collaboration, transparent data sharing, risk assessment frameworks, adaptive regulatory approaches, stakeholder engagement, and capacity building, will be integrated into the recommendations to ensure holistic and effective responses.
The consultancy outlined in this ToR will focus on developing recommendations for harmonizing safety monitoring approaches across African countries, ensuring alignment with global best practices and regional needs. Africa CDC Science Directorate is seeking 2 (two) consultants for 3 (three) months.
2. TERMS OF REFERENCE (TOR) FOR CONSULTANCY POSITION:
2.1. SCOPE OF WORK:
Working in close collaboration with Africa CDC, CEPI, SPEAC and Member States, the consultant will:
I. Review and Analysis:
• Conduct a review of existing pharmacovigilance frameworks (including vaccine safety), protocols, and practices at continental, regional, and national levels.
• Identify gaps and areas for improvement in current tools and approaches used during vaccine deployment in public health emergencies.
II. Stakeholder Engagement:
• Collaborate with key stakeholders, including regulatory authorities, immunization programs, and pharmacovigilance systems, to collect insights and recommendations.
III. Development of Recommendations:
• Develop recommendations for harmonized tools, protocols, and practices for vaccine safety evidence generation, incorporating global best practices and tailoring them to the African context.
• Integrate strategies for risk assessment, adaptive regulatory approaches, and capacity building.
IV. Mechanism Development:
• Propose mechanisms for ongoing collaboration between key pharmacovigilance stakeholders and member States to ensure
sustainability.
• Establish frameworks for stakeholder engagement and coordination during vaccine deployment.
V. Documentation and Reporting:
• Compile a comprehensive report detailing the harmonized recommendations, including practical steps for implementation.
• Present findings to Africa CDC, CEPI, and other stakeholders as required.
3. DELIVERABLES:
• Situational Analysis Report: A detailed report summarizing existing tools, protocols, and practices for safety evidence generation in Africa.
• Recommendations for harmonization of tools, protocols, and practices tailored to the African context developed
• Mechanisms for ongoing collaboration and knowledge sharing between Africa CDC and partners developed
• Documentation of stakeholder engagements, including key insights and feedback.