Towards the end of 2020, there was a growing acknowledgement around the need for efficient and robust safety surveillance. This developed as many African countries prepared for national COVID-19 vaccination campaigns to begin. African NRA CEOs approached AU-3S to quickly implement or enhance ongoing safety surveillance protocols and activities for COVID-19 vaccines. The AU-3S pilot, which focused on supporting safety surveillance of COVID-19 vaccines, was subsequently launched in Ethiopia, Nigeria, Ghana, and South Africa. Ethiopia and Nigeria were selected as they were original entry points for COVAX vaccines. Ghana was selected as they chair AVAREF and have very strong safety surveillance systems (being rated Maturity Level 3 (ML3) by WHO). South Africa was chosen as it has the largest clinical trial base in Africa. Altogether, these 4 original AU-3S pilot countries compromise ~30% of Africa’s population.

As a first priority, AU-3S conducted a landscaping assessment of each pilot country’s safety surveillance systems to identify country needs and constraints. This helped inform future policy and strategic support that could be provided by the AU-3S programme.

A major challenge was found in the wide usage of paper forms across the pilot countries. This typically caused delays in collecting, analysing, and reviewing safety data once vaccines had been rolled out. To combat this, the AU-3S programme expanded the functionality and improved national use and effectiveness of the Med Safety App . The AU-3S team created and launched an AEFI form for use within the Med Safety App. Both healthcare workers and members of the public who wish to report any side effects that they experienced are encouraged to use the App. The App provides near real-time access to safety data and reduces the reliance on paper forms – ensuring that data is efficiently available for downstream analysis. Additionally, the AU-3S team supports national communication teams to successfully promote national usage of the Med Safety App.

AU-3S further created and implemented the interim Data Integration and Signal Detection (DISD) system to pool safety data from each country. The DISD system is the precursor to the AfriVigilance system which is the long-term systems objective for the AU-3S programme. The DISD system was implemented primarily to meet the urgent need for robust safety surveillance of COVID-19 vaccines.  The AU-3S Joint Signal Management (JSM) Group, an expert committee consisting of representatives from programme countries, was then formed to analyse this pooled safety data for any additional potential signals.

Finally, the AU-3S programme facilitated a series of capacity strengthening trainings which were conducted by world-class experts from the MHRA. These sessions covered topics along the end-to-end safety surveillance activity value chain. Capacity strengthening is also promoted through hands on signal detection activities as part of the AU-3S JSM Group Secretariat. The AU-3S team has furthermore created a network of nominated individuals from each programme country to be the national exert (super user) of the Vigilance Hub. Additional trainings and knowledge sharing on the Med Safety App and Vigilance Hub is continuously provided to this network. For further information on all AU-3S capacity strengthening initiatives, click here.