Russia began rolling out Sputnik V long before proof of its efficacy was published, and China has been criticised for rolling out vaccines without sufficient transparency about clinical trial data. Pictures: AFP
The South African Health Products Regulatory Authority (Sahpra) says its Covid-19 vaccine approval process is as fast and efficient as it can be.
This comes as political pressure has mounted over the last week with the Economic Freedom Fighters (EFF) set to protest outside the health body’s headquarters in Tshwane on Friday over the continued wait for the Russian Sputnik V vaccine and others to be approved for use in South Africa.
The party also wants Chinese vaccines, Sinopharm and Sinovac, to be approved for use in SA.
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The body held a webinar on Thursday aimed at debunking assumptions about the vaccine approval process and assuring citizens tof Sahpra’s independence and scientific precision, with which it handles applications for Covid-19 vaccines and other medicines.
According to Sahpra chief executive officer (CEO) Boitumelo Semete-Makokotlela, the body has dedicated a significant amount of resources into managing and expediting the process of vaccine approval.
There are three factors considered in the application: quality, efficacy and safety. In terms of quality, the body looks at whether the product complies with good manufacturing practices, while efficacy relates to scientific evidence that the medicine works as proposed.
The safety aspect looks at adverse effects, which in the context of Covid-19 vaccines, is an ongoing data collection process.
Professor Marc Blockman, chair of the pharmacovigilance committee at Sahpra, explained that the body’s decisions were influenced by a multitude of factors, including that of other regulatory bodies around the world and all the scientific evidence available to it.
“We rely not only on what is put in front of us in terms of a rolling dossier or dossier of data, which we will look to analyse, but also we rely on what other regulatory environments have suggested as well as for example, the WHO [World Health Organization] and take all of these into consideration when making a decision on the safety and effectiveness of medicine but also on a vaccine in this situation,” Blockman said.
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The body relies both on published and unpublished data in this regard. There is also a post-approval commitment to continue monitoring the effects of vaccines in the rollout, to prevent severe illness after patients have received vaccines.
Side effects are being monitored by the body on a daily basis. This process has included the training of healthcare workers to enable them to recognise adverse events and report them to Sahpra in a timeous fashion.
This week Sahpra confirmed it received documentation for the Sinopharm vaccine, developed by the China National Pharmaceutical Group. The regulatory body will now commence with evaluating the data in assessing the efficacy of the vaccine.
Sahpra board chairperson Dr Helen Reese confirmed that South Africa was seeing breakthrough Covid-19 infections, in other words, infections in vaccinated people.
“With a new disease like this all of these vaccines are brand new, so when you approve them, what you have is…varying degrees of clinical data that tell you how effective the vaccine is likely to be. One of our challenges in South Africa is that there is very little clinical data,” said Reese.
“There is some about how the vaccines perform in the context of the beta variant, which is the dominant variant, but it’s limited at best and so we have go on the cumulative knowledge that we have about antibodies and the clinical data and then we introduce it into the field.”
Sahpra is developing a national protocol to look into the causes of breakthrough infections and who they are most likely to affect, by evaluating factors such as age, comorbidity and strain of virus.
“Although we are looking at breakthrough infections, it would appear that according to early data from the J&J [Johnson & Johnson] vaccine… many of those infections are mild to moderate disease. And in fact we are seeing this reduction in severe disease.”
simnikiweh@citizen.co.za
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