21 August 2020 - NW1555
Madlingozi, Mr BS to ask the Minister of Health
What (a) total number of Covid-19 vaccine trials are taking place in the Republic at the moment, (b) are the names of the companies conducting the specified vaccine trials and (c) safety measures are in place to ensure that the persons who are participating in the vaccine trials are protected?
(a) There are currently two (2) ongoing COVID-19 vaccine trials in South Africa;
(b) The vaccine trials are conducted by the Respiratory and Meningeal Pathogens Research Unit, Wits Health Consortium (ChAdOx1 SARS-CoV-2 Trial) and TASK Applied Science (TASK-008 BCG- CORONA Trial); and
(c) In general, Regulation 30 of the Medicines Act (Act 101 of 1965, as amended) mandates the South African Health Products Regulatory Authority (SAHPRA) to regulate the conduct of all clinical trials in the Republic of South Africa. In carrying out this legislative mandate, SAHPRA is guided by relevant sections of the current South African Good Clinical Practice (SAGCP) Guidelines.
Specifically, sub-regulations 30(10)(b) and (c) empower SAHPRA to inspect clinical trial sites and/or withdraw authorization to conduct clinical trials, respectively. Withdrawal can be for reasons of compromised safety of trial participants, or changes in the original science behind the trial, or where the integrity of the data being generated becomes compromised. In addition, SAHPRA, in line with current SAGCP Guidelines, ensures that all protocols have had adequate oversight by registered ethics committees as part of its clinical trial protocol approval process.
All these regulatory measures taken by SAHPRA during protocol approval, and subsequent trial monitoring by both site inspections and safety monitoring reports, serve to ensure that persons participating in all clinical trials conducted in South Africa are protected from harmful and unethical medical conduct.