Reference:
South African Health Products Regulatory Authority. (2021, August 20). SAHPRA statement on adverse events following immunisation (AEFIs) with COVID-19 vaccines.
Summary:
The South African Health Products Regulatory Authority (SAHPRA) oversees the safety of COVID-19 vaccines in collaboration with the National Department of Health (NDoH). Since the national vaccination roll-out commenced on 17 May 2021, SAHPRA has received 1,473 reports of adverse events following immunisation (AEFIs), primarily mild and non-serious, accounting for a 0.02% reporting rate from nearly 7.1 million doses administered. Serious AEFIs, although rare, are defined by specific criteria and require immediate reporting. A multi-disciplinary team investigates these cases within 48 hours, with causality assessments conducted by the National Immunisation Safety Expert Committee (NISEC). Findings indicate that most reported serious AEFIs were coincidental to vaccination, with only four cases deemed unclassifiable due to inadequate information. Public and health professionals are urged to report AEFIs through various channels. SAHPRA is also launching a microsite to provide information on AEFI reports.