OVERVIEW
The African Union – Smart Safety Surveillance (AU-3S) program, led by the African Union Development Agency (AUDA-NEPAD), asserts its commitment to establishing a robust continental safety monitoring system for enhancing the safety of crucial medical products across Africa. In partnership with the Bill and Melinda Gates Foundation (BMGF), AU-3S drives the establishment of an African Vigilance database, ensuring meticulous monitoring of therapeutics and vaccines. The overarching objective is creating a database facilitating seamless information exchange within Africa and beyond, elevating global health commodity safety standards.
Initiated in 2020 with a strategic timeline spanning approximately a decade, the AU-3S program receives funding from BMGF, with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) playing a pivotal role as a technical partner. The program staunchly aims to confront the glaring deficiencies in health systems and safety surveillance capacities across Africa. Leveraging technological innovations, capacity building, resource pooling, and collaborative efforts, AU-3S endeavors to fortify safety surveillance mechanisms.
In the past three years, the AU-3S program has diligently positioned itself as the cornerstone of continental safety surveillance. It has forged close partnerships with founding countries – Ethiopia, Ghana, Kenya, Nigeria, and South Africa while extending strategic and technical support to enhance vigilance functions and safety surveillance capacities across the continent. The AU-3S, having transitioned from the project’s pilot phase, has embarked on an expansion drive to include additional Member States, underscoring its transition from a pilot phase to a continent-wide initiative.
Phase 2 of the program, currently underway, focuses on optimizing solutions, continual collection and analysis of safety data, and expanding solutions to encompass other member states and identified priority medical products. The program currently has 12 participating countries namely the Democratic Republic of Congo, Egypt, Ethiopia, Ghana, Mozambique, Kenya, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Uganda. Moreover, the product scope encompasses seven additional products across five priority disease areas – malaria, TB, HIV/AIDS, polio, and COVID-19.
LANDSCAPE ASSESSMENT
The AU-3S program prioritized assessing safety surveillance systems in pilot countries to understand their needs and limitations. They found that paper forms caused delays in data collection and analysis post-vaccine rollout. To address this, they enhanced the Med Safety App, encouraging both healthcare workers and the public to report side effects/adverse events, thus improving data accessibility and reducing reliance on paper forms. Additionally, they established the interim Data Integration and Signal Detection (DISD) system to gather safety data across countries for COVID-19 vaccines. An expert committee, the Joint Signal Management (JSM) Group, was formed to analyze this data for potential signals. Capacity strengthening efforts were made through trainings by experts from MHRA, covering various aspects of safety surveillance. In Nigeria, a landscape assessment identified gaps in the pharmacovigilance system, which were addressed through capacity-building sessions conducted by MHRA under the AU-3S program. These efforts have improved the capacity of health workers in data collection and signal detection, positively impacting the surveillance of COVID-19 vaccine safety in Nigeria.
PILOT PHASE (FIRST SUB-DELEGATION AGREEMENT)
The pilot phase of the BMGF-sponsored AU-3S initiative for COVID-19 vaccines, launched in 2020, serves as a trial for a forthcoming continent-wide safety surveillance system encompassing all medical products. Focused primarily on enhancing the safety surveillance of COVID-19 vaccines, this phase was executed across five countries: Nigeria, Ghana, South Africa, Kenya, and Ethiopia. Safety data from these nations is consolidated into the Interim Data Integration and Signal Detection (DISD) system for cross-country signal management activities.
NAFDAC, with the support of the first sub-delegation worth 100,000 USD, undertook proactive measures as follows:
- Collaboration with Sister Agencies and Partners:
NAFDAC initiated a comprehensive collaboration with various stakeholders including the National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, WHO, and Ministry of Health. This collaboration aimed at employing a holistic approach to vaccine delivery and monitoring Adverse Events Following Immunization (AEFI). NAFDAC’s participation in an expanded technical working group ensured meticulous planning and safety surveillance of COVID-19 vaccines introduction in Nigeria.
- Public Communication Strategies for the Med Safety App:
Before the introduction of the COVID–19 vaccine, NAFDAC issued three public alerts and safety communications via press releases, emphasizing the safety of COVID-19 vaccines and clarifying vaccine-related information. The Med Safety App, launched in Nigeria in November 2020, was expanded to capture AEFI reporting forms. NAFDAC intensified efforts through sensitization campaigns, training sessions for healthcare providers, and provision of internet-enabled tablets to enhance Med Safety App usage.
- Training of State Epidemiologists, State, LGA Disease Surveillance and Notification Officers (DSNOs) and NAFDAC State Pharmacovigilance Officers:
NAFDAC conducted systematic virtual trainings on the Med Safety App for various cadres of health workers across states and LGAs, ensuring widespread understanding and usage of the app. Trained personnel cascaded the training to vaccinees and vaccination officers, increasing Med Safety App adoption.
- Enhanced Passive Surveillance After 1st and 2nd Phases of Vaccinations:
NAFDAC implemented an enhanced passive surveillance approach, deploying trained designated pharmacovigilance focal persons to monitor COVID-19 vaccine implementation through multiple rounds. These personnel followed up with identified vaccinees to monitor for AEFIs and trained other health workers at vaccination sites. Reported AEFIs were uploaded into the Med Safety App, evidencing increased AEFI reporting within one month of implementation. This initiative aimed at further characterizing the safety profile of vaccines within Nigeria’s population, complemented by the Cohort Event Monitoring in collaboration with US-CDC, University of Maryland Baltimore.
In total, these assertive actions by NAFDAC during the pilot phase significantly contributed to the AU-3S programme’s objectives, ensuring robust safety surveillance of COVID-19 vaccines in Nigeria.
CONTINENTAL WORKING GROUP(CWG)
In March 2023, the AU-3S secretariat proposed an expansion for the program, but further research and planning were required. An Ad Hoc Continental Safety Platform Working Group (CWG) was established to create a roadmap to guide AU-3S towards a sustainable continental safety monitoring platform. The CWG members were selected from participating member countries by NRA CEOs/DGs and from the AU Commission’s Department of Education, Science, Technology, and Innovation (ESTI). The CWG identified several focus areas crucial for the platform, like country and product scope expansion, signal management, technology optimization, partnership, stakeholder engagement, and sustainability and financing.
Over seven meetings, the CWG formulated recommendations within each focus area and proposed a roadmap to guide AU-3S toward a functional and sustainable continental safety monitoring system while expanding to more member countries and products. The CWG held four virtual working sessions and two face-to-face meetings, including one inaugural meeting, and each discussion topic was facilitated by co-chairs, with AU-3S and BMGF providing materials and discussion guides.
JSM AND JSM SECRETARIAT
A Joint Signal Management (JSM) Group has been established, comprising members from five countries. The group’s purpose is to evaluate potential signals from aggregated data obtained through the med safety app, thereby strengthening the countries’ signal detection and management capabilities. The JSM Secretariat supports the JSM group by routinely analyzing cross-country safety data and validating potential signals. The secretariat includes national representatives from the five member countries, supported by AU-3S and MHRA. NAFDAC actively participates in the JSM Secretariat and JSM signal management meetings as well as the Med Safety App super user’s meetings.
SECOND SUBDELEGATION
The second sub-delegation, sponsored by BMGF, with the support of 100,000 USD began in September 2023, with the receipt of the first tranche of 70, 000 USD. The project is expected to end in September 2024. The AU-3S Program Support: 2nd Sub-delegation has achieved the following so far:
- Strengthening Capacity of Zonal Pharmacovigilance Centres(ZPCs) and Health Facilities(HF) in Nigeria
The NAFDAC Pharmacovigilance Directorate engaged the state Coordinators and state PV focal persons across the 36 states and the FCT in carrying out advocacy visits to the state’s ministries of health and some selected high-volume health facilities and Community Pharmacies in the states. The objective of the advocacy was to obtain the support of the state ministries of health towards implementing pharmacovigilance. Secondly, to receive the nomination of participants from the various facilities who will be trained on pharmacovigilance. Nominations were to cut across different cadres of health professionals including Doctors, Nurses, pharmacists and Medical Lab scientists. Some participants were also taken from the LMCU and the various disease programs under the ministries of health. The training commenced in October 2023 with the following results:
- Training of HCPs on Pharmacovigilance has been conducted in 34 States
- Over 2000 HCPs from about 500 HFs trained across states
- Increase Downloads and active users of the Med Safety App
- Capacity strengthening of the six Zonal Pharmacovigilance Centers(ZPCs) and ZPCs coordination of pharmacovigilance activities in their zones:
A needs assessment was conducted at the various zones and the coordinators submitted work plans so that funds disbursed to them will be focused on key activities for set goals. The first tranche of funds has been disbursed to the ZPCs to implement their activities. The ZPCs are being followed up to ensure the appropriate implementation of work plans
Other planned Activities include:
- Active Monitoring of Bedaquilline/Dolutegravir Tablets
- Pharmacovigilance Inspection of Selected MAHs
- Data Review Meeting
For more on the AU3S program Visit https://www.nepad.org/microsite/african-union-smart-safety-surveillance-au-3s
