Vaccine pharmacovigilance in South Africa: successes and limitations of current approaches

Introduction: Despite the public health success of vaccination, there is an ongoing need to build public confidence in vaccines and improve systems to monitor safety while maintaining data security and patient privacy. African countries face multiple challenges in establishing systems for vaccine pharmacovigilance as was demonstrated during COVID-19 mass vaccination. We provide a framework for the development of pharmacovigilance using the COVID-19 vaccination rollout as an exemplar. Areas covered: We describe the pre-COVID-19 vaccine pharmacovigilance systems in Southern Africa and propose improvements based on our experience of COVID-19 vaccine rollout in South Africa where we implemented systems to evaluate real-world safety and effectiveness of COVID-19 vaccinations. By conducting a PubMed review of the literature on pharmacovigilance with a focus on Africa and from guidance emanating from the World Health Organization (WHO), we evaluate challenges and opportunities to improve pharmacovigilance in our setting. Expert opinion: There are ongoing efforts to improve pharmacovigilance on the African continent with improved coordination at a national level with the support of the WHO, the national regulatory authorities, and national departments of health. COVID-19 vaccine rollout provided an opportunity to improve pharmacovigilance by integrating national vaccine platforms with active and passive surveillance including hospital and death registries.