R OITUMELO SEMETE

CEO of the South African Health Products Regulatory Authority (SAHPRA)

s South Africa ramps up the nationwide Covidvaccination programme, criticism leveled at the government ranges from the slow pace of the rollout, to questioning the efficacy of the vaccines. owever, CE of the South African ealth roducts Regulatory Authority SA RA , r Boitumelo Semete, is reassuring.

Charged with heading the regulatory body responsible to review and approve Covid- vaccines in the country, Semete says the body has been successful in VXSSRUWLQJ WKH FRXQWU\ȢV ˋJKW DJDLQVW Covid- and was able to demonstrate that they could authorise vaccines speedily.

A biochemist with a background in TB and I drugs research, Semete joined the regulatory body in January , shortly before the national lockdown was declared. Since then, it has been a whirlwind as the country grappled with the pandemic and looked to SA RA for solutions.

“While these vaccines have been authorised in one country, we needed to ensure that we conduct thorough reviews in South Africa as SA RA — reason being that all of these vaccines are new, even when they have authorisation from other countries, none of them have a full registration and we’ve done some very thorough reviews of these vaccines.”

“As an organisation we were able to demonstrate what we can deliver in a short timeframe and a lot of our processes and pathways had to accelerate,” says Semete, further e plaining that their approach is always informed by science and also ensuring that every product, which receives the regulator’s approval, is safe.

“We had diagnostic tests registered in record time and we’ve got very good diagnostic tests in the country and haven’t had to recall any of them. South Africa participated in a number of international studies and all of those studies had to be submitted to SA RA and we reviewed them in record time. The speed at which we’ve been able to deliver really is commendable for an organisation that is under resourced and the team really pulled together quite well to deliver on this,” she says.

QH RI WKH OHDGLQJ ˋJXUHV LQ WKH ˋHOG RI science, technology, engineering and maths, Semete has built a formidable career in both the private and public sectors. She sits on various boards and VFLHQWLˋF DGYLVRU\ FRPPLWWHHV LQFOXGLQJ the vaccine ministerial advisory committee. While the timing of the pandemic was not ideal — shortly after she took on the new role at SA RA — Semete has no regrets and concedes that her winning formula of working hard and applying e cellence in everything she does, as well as giving each role , has been the cornerstone of her success. She believes that it is a matter of time before South Africa produces its own, homegrown vaccines. “As a country, we’ve got the research and development capability, very good universities and science councils and a very strong commercial entities sector. We’ve got the capability to license technologies as an immediate solution, while we work towards a mid- to long-term plan to make our own vaccines,” she adds.