Expansion of the AU-3S Programme
The African Union Smart Safety Surveillance (AU-3S) programme launched in early 2020 with the aim to pilot its initial objectives in four African countries (Ethiopia, Ghana, Nigeria, and South Africa). AU-3S aims to enhance African ownership of African data, the issue of low adverse event reporting, limited safety expertise in Africa and siloed safety surveillance systems. AU-3S has a ten-year ambition to strengthen the continent's safety surveillance of new and innovative health products in priority disease areas in Africa: malaria, tuberculosis, HIV/AIDS, and other emergency diseases such as COVID-19 and Ebola.
The programme has grown significantly, dating from its inception. In March 2022, the AU-3S started scaling up geographically by onboarding Kenya as the newest country in the programme. In the early stages, the four pilot countries within the programme comprised 30% of the African continent's population, and, with Kenya's onboarding, the programme now encompasses approximately 35% of the African population. The addition of Kenya is an important milestone as it signals the beginning of the AU-3S expansion plan.
After signing the agreement between Kenya and AUDA-NEPAD in March 2022, Kenya started participating in the activities of AU-3S. The Chief Executive Officer of the Pharmacy and Poisons Board (PPB) Kenya, Dr Fred Siyoi, was formally introduced as the newest member of the AU-3S Steering Group. Dr Siyoi spoke on behalf of the PPB during the opening of this year's first Steering Group meeting, saying,"We feel very welcome to the expanded group, and I promise that we will participate fully and contribute to the discussions; going ahead."
The Kenya Pharmacy and Poisons Board (PPB) is the National Regulatory Authority (NRA) charged with the mandate to regulate the practice of pharmacy, manufacturing, and trading of drugs and poisons, including vaccines. There have been numerous engagements between AU-3S and the Kenya PPB to facilitate a smooth onboarding of the newest member to the programme and better understand the state of the country's safety surveillance system. This exercise enabled the AU-3S programme to provide fit-for-purpose intervention(s) to ensure that Kenya's COVID-19 vaccines' safety data is seamlessly integrated with the AU-3S Data Integration and Signal Detection (DISD) system. The members of the Steering Group expressed their warm welcome to Kenya, noting that Kenya's historically well-known and robust safety system as a part of their regulatory system will be an added advantage to the discussions. Kenya has actively participated in all meetings of the AU-3S programme, including the Joint Signal Management Secretariate meetings, since its official onboarding. Furthermore, a plan is underway to engage the National Vaccines and Immunization Programme (NVIP) of Kenya, as the organization works closely with the NRA on vaccine safety surveillance.
Now that Kenya has successfully been onboarded, the AU-3S programme continues to work collaboratively with its stakeholders to guide the process and ensure the best practices used by the four countries; Ethiopia, Ghana, Nigeria and South Africa- regarding collaboration are applied.
Alongside the geographical expansion, the AU-3S is exploring increasing the scope of products to include COVID-19 therapeutics to keep testing the AU-3S solutions.
The AU-3S programme will continue to communicate more details of the expansion process.