The Portfolio Committee on Health received a virtual briefing from the South African Health Products Regulatory Authority (Sahpra) yesterday on the delivery of Covid-19 vaccines; further findings/data on vaccines; the use of Ivermectin and an update on the court ruling; and on the application process for vaccine manufacturers.
The Chairperson of the Board of the Sahpra, Prof Helen Rees, told the committee that Sahpra is a regulatory authority and its validation of medical products in the health care system is driven by science. “We do all we can to ensure that our validation processes are science-driven and can’t be influence by any other variables besides the strict scientific processes we have in place that approves all the medicines that we validate for consumption in our care system, explained Prof Rees.
As a statutory body, Sahpra should remain as a neutral and independent as possible, and be protected from any social or political pressures in how they conduct their validation processes. Prof Rees stated this unequivocally as committee members asked why the vaccine approval process has experienced some administrative bottle necks, when they are needed to mitigate growing infection rates.
Sahpra’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, explained the validation process that any health product must observe before is allowed in the health system. She explained that the current approval processes have been consolidated to mitigate the current health emergency.
Normally, she said: “It takes five to six years or more in cases such as TB and Aids to develop a vaccine. And thus is often followed by a strict validation process that is equally elongated.” This process has been consolidated in the case of Covid-19 and it now takes 90 days to validate the safety and efficacy of vaccines.
“We have consolidated our validation process of vaccines to ensure that they meet our medical standards. We would have loved to have more vaccines in our system, but we can’t do that without due diligence.” She told the committee that, globally, there are well over 200 vaccines under World Health Organisation’s authorization process currently being clinically developed and that are subjected to due diligence.
One of the basic criteria used to authorise a vaccine is to determine its quality, efficacy and safety to reduce its margin of side effects. Above that, she said applicants must prove that their vaccines have gone through clinical studies and their company is able to assess and report its side effects and efficacy against any variant, among other things.
Sahpra is in a process of collating data on side effects. “We have since developed a concept to report on the adverse events following immunisation and adverse events of special interest. A more detailed report on this will be published soon,” she said.
Sahpra’s Chief Regulatory Officer, Ms Portia Nkambule, explained that companies producing vaccines must report the adverse effects of their products weekly and its safety monthly and explain how it will mitigate these effects. But beyond that, there is a multipronged approach to reporting, “we get virology reports on variants from virologists, from medical doctors and patients are encouraged to report any symptoms they may experience after vaccination”.
In her presentation, the Acting Minister of Health, Ms Mmamoloko Kubayi, said she is pleased with the progress of vaccination roll-outs thus far. “We have now achieved the 250 000 daily target and we have now opened the 30+ age bracket vaccination roll-out and well over one million of them have registered.” In addition, vaccines are now being made available to the security cluster which includes police and soldiers.
Several members of the committee asked about the age approach to vaccination, which has come in for some criticism. The National Health Insurance Fund developer in the Department of Health, Mr Nicholas Crisp, maintained that the age approach is by far the best scientifically proven effective method of arresting infections. “It’s has been scientifically proven that over 60-year-old persons are prone to infections more than other age groups.”
The Chairperson of the Committee, Dr Sibongiseni Dhlomo, said the committee would be pleased to get regular updates from Sahpra on the progress of vaccines that are in its validation process to mitigate the security of vaccine supply and demand. “We will continue to engage and we can’t wish each other away on this matter; it’s of great concern to all,” he said.
“we want to ensure that the security of the supply of vaccines is nor jeopardised and that we meet our vaccination targets as a country. And in the process, we want to quell any untoward perception or suspicion about the important work that you are entrusted with.”
Dr Dhlomo commended the department for the progress registered thus far and urged it to work towards meeting the 300 000 daily vaccine coverage target set by the president to ensure that the vaccine coverage is improved and South Africans are immunised to protect them against the corona virus infection.
23 July 2021