The COVID-19 pandemic and COVID-19 vaccines rollout, by their unprecedented nature and record timelines respectively, further strengthen the importance of safety surveillance. To support stakeholders in conducting safety surveillance, the World Health Organisation has published the “COVID-19 Vaccines: Safety Surveillance Manual”. This manual is a comprehensive set of guidelines that all countries are encouraged to leverage as a core document in ensuring the successful safety surveillance of their populations during their COVID-19 vaccine(s) rollout. The World Health Organisation has also released a protocol for active vaccine safety surveillance titled “Cohort event monitoring (CEM) for safety signal detection after vaccination with COVID-19 vaccines” – based on the principles outlined in the WHO COVID-19 Vaccines Safety Surveillance Manual – and has published interim guidance to aid “Evaluation of COVID-19 vaccine effectiveness”.
This AUDA-NEPAD publication aims to provide a series of reflections to successfully implement the abovementioned guidance, within the context of Africa. Additionally, this document presents relevant tools, materials, and initiatives to support African countries to effectively implement safety surveillance of COVID-19 vaccines and future medical products and provides learnings based on the experiences of the African Union Smart Safety Surveillance programme.
The document has two main sections. The first section focuses on outlining the importance of pharmacovigilance generally and specifically for COVID-19 vaccines, after which unique challenges and considerations in the context of Africa are discussed. The second section provides a series of recommendations to successfully implement safety surveillance in Africa in the light of all identified challenges and considerations. These recommendations are grouped into 6 key categories: passive surveillance, active surveillance, manufacturers’ pharmacovigilance activities, training and capacity strengthening, collaboration and coordination, and safety communications.
