Ivermectin no longer allowed to treat COVID-19.
Approved formulations of Ivermectin to be ‘considered’ by SA regulators
The Department of Health has provided an update on the controversial Ivermectin drug for the management of COVID-19.
Ivermectin no longer allowed to treat COVID-19.
Doctor Aquina Thulare from the National Health Department provided an update on the Ivermectin drug that has been the talk of the town lately. While it hasn’t been approved by the South African Health Products Regulatory Authority (Sahpra) for the management of COVID-19 on humans as yet, Thulare said it is considering enabling access to approved formulations that are intended for human use.
While presenting the framework that was adopted for the implementation of the vaccination in the country, Thulare said she wanted to end her presentation off by addressing an issue they picked up…the anxieties around why Ivermectin is not being “implemented” or used, so to speak.
If you didn’t know, several investigators have reported that when tested in the laboratory, Ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus, therefore, several clinical studies have been undertaken to evaluate the drug’s efficacy in treating the COVID-19 infection.
SAHPRA occasionally grants Section 21 permits for the use of topical Ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice, however, its main use is for animals.
‘NO POSITIVE RECOMMENDATIONS AT THIS STAGE’ – THULARE
Thulare said there have been no positive recommendations at this stage for the use of Ivermectin in the management of COVID-19 infections by any regulatory authority.
“Sahpra has got relationships with [these] entities and has looked at the work that has been done around Ivermectin and this is the position that we are at at this stage. The WHO does not currently recommend the use of Ivermectin for the treatment of the virus and we also know that there is no clinical trial applications that have been submitted to Sahpra for review on Ivermectin at this stage,” said Thulare.
“As of the 22 December Ivermectin has therefore not been approved by Sahpra for use in humans and there is no confirmatory data available on the drug. In terms of the safety and efficacy of this agent, there is no evidence at this stage to support the use of Ivermectin,” she added.
COVID-19 SAHPRA CLOSELY MONITORING IVERMECTIN TRIALS
Thulare said Sahpra has committed to fast-track any review that has been submitted to it as an application, should it be submitted.
“As I’ve indicated at this stage, there is no application that has been submitted. Sahpra is encouraging and supports world design ethically-approved scientific studies and will continue to evaluate any emerging peer-review publication or data on the use of Ivermectin for the use of COVID-19,” she said.
She went on to say that Sahpra is aware of global clinical trials that have been registered. Thulare said there are a few trials that are currently underway in Egypt Brazil and Japan.
“Sahpra is monitoring how these trials are currently unfolding and at the appropriate time, when there’s sufficient evidence, will pronounce on their view of the clinical trials. Sahpra will also consider enabling access to approved formulations of Ivermectin intended for human use, including through section 21 meaning emergency approvals, provided such a request is supported by evidence,” she added.
