A medical worker speaks to a patient at a coronavirus test facility in Pretoria.
Photographer: Waldo Swiegers / Bloomberg
Photographer: Waldo Swiegers / Bloomberg
South African authorities have approved the use of a drug used to control parasites in humans and animals to treat patients with coronavirus.
The drug, known as ivermectin, will be allowed for compassionate use in a controlled access program, the head of the South African Health Products Regulatory Authority said on Wednesday. Doctors who apply for the regulator for the use of the drug will be considered on a case-by-case basis, Boitumelo Semete-Makokotlela said.
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Ivermectin has been used for decades to treat animals infested with parasitic worms, while in humans it is used as a topical ointment for diseases, including skin infections and inflammation. The World Health Organization has suggested that the drug has encouraging effects on coronavirus, although, like other regulators, it also says that the medication has not been properly evaluated.
The drug will not be limited to patients with known Covid-19 comorbidities, said Semete-Makokotlela.
The regulator is already seeing widespread use of ivermectin in an emerging black market, while South Africa is fighting a second wave of coronavirus infections that has resulted at the hospital rising admissions and a shortage of critical care beds. Enabling controlled use of the drug will help the regulator monitor its use and allow the body to collect much-needed safety data.
‘Despair’
“We absolutely share everyone’s desperation at this point,” said Helen Rees, president of the regulator. “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. That’s why we need to get data ”.
Authorities in neighboring Zimbabwe also approved the use of ivermectin to treat patients with coronavirus, after doctors called on the Ministry of Health to reverse a previous ban on the import and use of the drug. Doctors in Zimbabwe are using ivermectin in a nano-silver solution – which is used as an algaecide – and found the combination to be “a game changer,” said the College of Primary Care Physicians in a letter to the ministry.
Rees warned South Africans that people who self-medicate “need to be very careful because we have no information on the quality of what you are taking”.
Clear guidelines on the implementation of the controlled access program will be provided in the next two days, said Semete-Makokotlela. There are also plans to conduct large-scale clinical trials, she said.
It is not the first time that authorization has been granted for the use of promising treatments and drugs from Covid-19 with only initial evidence. Several drugs that were released last year for treatment failed to replicate the initial benefits once examined in large clinical trials.
Semete-Makokotlela also said that the regulator granted the health department permission to distribute the coronavirus vaccine made by AstraZeneca Plc and the University of Oxford, the first for Covid-19 inoculations. It is also reviewing orders from rival manufacturers Johnson & Johnson and Pfizer Inc., but has not yet received an order from Moderna Inc., she said.
The South African official also had pre-presentation talks with “many other” vaccine manufacturers, including from China and Russia, said Semete-Makokotlela.
– With the help of Desmond Kumbuka
(Updates with Zimbabwe approving drug use in the second paragraph after the subtitle Despair)