SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines. The National Department of Health (NDoH) Expanded Programme on Immunisation (EPI) is responsible for the COVID-19 vaccination programme, and therefore collaborates with SAHPRA to oversee vaccine safety monitoring and reporting of adverse events following immunisation (AEFIs) throughout the country. Suspected AEFIs to COVID-19 vaccines are reported by health professionals and the public to SAHPRA and the NDoH. Certain adverse events have been designated by World Health Organisation (WHO) as adverse events of special interest (AESI). AESIs need to be carefully monitored and any potential association with vaccination must be confirmed by further investigation.