DURBAN - The South African Health Products Regulatory Authority (Sahpra) has denied that it had compromised on the safety of Covid-19 vaccines currently being used in the national vaccine rollout programme.
In a statement, the medicines regulatory body said it was an independent, science-based entity that followed strict guidelines and processes when approving health products.
Sahpra said like regulators across the world it always ensured the safety, quality and efficacy of health products, including the Covid-19 vacccine.
Sahpra CEO Dr Boitumelo Semete denied that it had compromised safety by fast tracking the approval of Covid vaccines.
“These essential requirements are consistently applied to all Covid-19 vaccines and therapeutics that Sahpra has considered for use in the country. The medicines’ approval process entails a rigorous process of assessment, where all information provided by the applicant is carefully evaluated by experts in their respective fields.
“While Sahpra has drastically reduced our usual time frames for the registration of Covid-19 vaccines, it has not cut back on the regulatory requirements to ensure that all these health products are safe and effective. Sahpra will not compromise on the safety of South Africans and will not endanger South African lives,” she said.
Semete added that Sahpra takes into account the local epidemiology in making decisions.
“Specifically when it pertains to Covid-19, efficacy of vaccines against the SARS-CoV-2 variants of concern circulating in the country is critical.
“Applicants have to provide data wherein they demonstrate vaccine efficacy against the variants of concern to Sahpra. Thus, a key contributor to the time frame is whether this data is readily available from the applicants or not,” she said.
In June the EFF which was demanding that Sahpra approve Russian and Chinese made Covid vaccines, accused the body of being politically “captured” into approving vaccines.
“The calls for Sahpra to approve vaccines without adherence to the critical components of safety, quality and efficacy could compromise public safety and these calls run contrary to the Sahpra mandate. Sahpra cannot be influenced by political pressure or any other pressure,” said Semete.
She said that the safety of the public was a priority for the regulator, “In order to ensure this, Sahpra applies its guidelines, regulations and rules consistently. It will be a sad day in the country when the regulator is undermined or influenced by any political party. Furthermore, the Sahpra Board, that is appointed by the Minister of Health, is not involved in operational matters of Sahpra.”
Semete said the Sahpra Board focused on matters of governance as per the Medicines and Related Substances Act, Act 101 of 1965, and that all regulatory and operational decisions were the responsibility of the Sahpra CEO, and not the Sahpra Board.
“The Chairperson of the Board, Prof Helen Rees, does not act alone in terms of Board decisions, but reflects a collective decision by the entire Sahpra Board.”
THE MERCURY