South African authorities approved the use of a drug used to control parasites in humans and livestock to treat coronavirus patients.
The medicine, known as ivermectin, will be allowed for use on compassionate grounds in a controlled-access program, the head of the South African Health Products Regulatory Authority said Wednesday. Medical practitioners who apply to the regulator to use the drug will be considered on a case-by-case basis, Boitumelo Semete-Makokotlela said.
Ivermectin has been used for decades to treat livestock infested with parasitic worms, while in humans it’s used as a topical ointment for diseases including skin infections and inflammation. The World Health Organization has suggested the drug has encouraging effects on coronavirus, though like other regulators it’s also said the medication hasn’t been properly evaluated.
The drug won’t be limited to patients with known Covid-19 co-morbidities, Semete-Makokotlela said.
The regulator is already seeing widespread use of ivermectin in an emerging black market, as South Africa grapples with a second wave of coronavirus infections that’s resulted in hospital admissions soaring and a shortage of critical-care beds. Allowing controlled use of the drug will help the regulator monitor its use and enable the body to collect much-needed safety data.
“We absolutely share everyone’s desperation at this point,” said Helen Rees, the regulator’s chairwoman. “So the question about ivermectin and self-medication goes back to what everyone in the scientific community is saying. And that is, we don’t know if it works and we don’t know if it doesn’t work. That’s why we need to get data.”
Authorities in neighbouring Zimbabwe also approved the use of ivermectin to treat coronavirus patients, after doctors appealed to the Health Ministry to reverse an earlier ban on imports and use of the drug. Physicians in Zimbabwe are using ivermectin in a solution with nanosilver — which is used as an algaecide — and found the combination to be “a game changer,” the College of Primary Care Physicians said in a letter to the ministry.
Rees warned South Africans that people self-medicating “need to be very careful because we don’t have any information about the quality of what you’re taking.”
Clear guidelines on the roll-out of the controlled-access program will be given in the next two days, Semete-Makokotlela said. There are also plans to hold large-scale clinical trials, she said.
It’s not the first time authorization has been given for the use of promising Covid-19 treatments and drugs with only initial evidence. Several drugs that were cleared last year for treatment have failed to replicate the initial benefits once examined in large clinical trials.
Semete-Makokotlela also said the regulator granted the health department permission to distribute the coronavirus vaccine made by AstraZeneca Plc and the University of Oxford, its first for Covid-19 inoculations. It’s also reviewing applications by rival manufacturers Johnson & Johnson and Pfizer Inc., but has yet to receive an application from Moderna Inc., she said.
The South African authority has also had pre-submission talks with “many other” vaccine makers, including from China and Russia, Semete-Makokotlela said.