The South African Health Products Regulatory Authority (SAHPRA) said it would reconsider allowing the use of Ivermectin to treat COVID-19 in South Africa if sufficient evidence of its effectiveness is produced.
This comes a week after the regulator cautioned citizens against using the drug, which is used to treat and control parasites in animals, as it has not been approved for use in humans in South Africa.
Ivermectin, however, has been touted as a miracle drug because of a widely quoted analysis by Dr Andrew Hill of the University of Liverpool, in which he conducted clinical trials on the drug as a treatment for COVID-19.
SAHPRA told Health24 that the data from Hill’s analysis has not been peer-reviewed and more randomised clinical trial data is needed before the clinical benefit of Ivermectin as a COVID-19 treatment can be confirmed.
More research is needed to determine the proper dosage, as well.
“SAHPRA, in its press release of 6 January 2021, has reiterated that it awaits data from current trials and will revisit the Hill meta-analysis when it is finalised and released at the end of this week,” said SAHPRA spokesperson Yuven Gounden in a statement.
“The overall quality of the randomised clinical trials involving Ivermectin in COVID-19 patients is poor and underpowered. From the available randomised control trial evidence, Ivermectin appears not to be superior to placebo in terms of viral load reduction or clinical progression.”
The statement further added that there is no evidence from the controlled trials that suggest the drug will reduce the mortality rate.
SAHPRA said it has received several Section 21 applications – a form used to apply for the authorisation to sell unregistered medicine –for the use of Ivermectin as a treatment or prevention of COVID-19 infections.
However, there have been no clinical trial or registration applications submitted to the regulator to date, according to Gouden. SAHPRA indicates that it will fast-track such applications provided they are up to standard.
“If there are clinical trial or registration applications submitted to SAHPRA for Ivermectin, these will be fast-tracked,” said Gouden. “The Section 21 applications will be reviewed pending the review of new data to support the use of Ivermectin in the treatment of COVID-19 infections.”