The South African Health Products Regulatory Authority (Sahpra) told MPs on Wednesday it is investigating adverse reactions to Covid-19 vaccines.
In briefing Parliament’s portfolio committee on health, Sahpra chief executive Tumi Semete-Makokotlela said they were closely monitoring “adverse events following immunisation” after reports of side effects.
She said a report would be released on Friday detailing the analysis being conducted on the adverse findings reported on the two vaccines now being administered in the country.
’’As at July 7, we had received 1 494 or so safety reports, 564 for the Pfizer vaccine, 930 for the J&J vaccine… In total, there have been 3 730 adverse events after immunisations that have been reported and analysed against the Pfizer and J&J. There are also those who have been reported in terms of special interest,” she said.
“There are causality studies that are currently ongoing. And what a causality study is to say, we need to determine if the event that we saw is indeed related to the vaccine or related to something else.
’’So, these are the very comprehensive studies that will be conducted, and autopsies will be done.”
In May, Sahpra announced the launch of the Med Safety App, which is designed to simplify and promote the reporting of suspected adverse drug reactions, including adverse events following immunisation by both the public and healthcare providers.
Updating the committee on the use of Ivermectin, Semete-Makokotlela said there was no evidence the drug, which was also not registered for human use, reduced hospital admissions and death.
"Ivermectin should not be used routinely in the management of any stage of Covid-19, except in the context of sufficiently powered Randomised Clinical Trials (RCTs), with well-defined study endpoints intended for regulatory marketing authorisation," Semete-Makokotlela said.
’’Much of the RCT evidence consists of trials of low methodological quality, for the most part, with small sample sizes and disparate interventions and controls, limiting the confidence in any conclusions with respect to ivermectin. No evidence of clinical or virological benefits.’’
Ivermectin should not be used routinely in the management of Covid-19, except in the context of a clinical trial.
In January, Sahpra agreed to allow doctors to start ivermectin treatment in cases deemed urgent.
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