South African epidemiologist and infectious diseases specialist Professor Salim Abdool Karim has warned against the administering of Ivermectin in the treatment of patients, reports IoL. “The Ivermectin available in South Africa is for animal use only. It would be professional misconduct for any doctor to prescribe it and any pharmacist to dispense it,” he said.
Karim, who heads up the Ministerial Health Advisory Committee (MAC) on COVID-19, said until more robust evidence was made available, the routine use of ivermectin either for the prevention or treatment of COVID-19 was not justified.
The South African Health Regulatory Authority (SAHPRA) has released a statement on the use of ivermectin for the treatment or as prophylaxis for COVID-19. It said: There are currently no applications either for clinical trials or for the registration of ivermectin for the treatment or as prophylaxis for COVID-19. However, SAHPRA encourages and supports all well- designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of COVID-19.
SAHPRA reiterates its commitment to expedite the review of such studies. Furthermore, as the South African regulatory authority, SAHPRA will continue to evaluate any emerging peer reviewed publications or data on the use of ivermectin for the treatment of COVID-19, and notes that according to the global clinical trials register, additional data should become available in the course of the next few months.
SAHPRA will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk benefit assessment that includes safety and clinical efficacy data.
The government’s statement on the use of ivermectin as a treatment for COVID-19 says:
It is dangerous to market ivermectin as a treatment against COVID-19 as the drug has not been properly tested for humans
– Ivermectin in the treatment for COVID-19 is still to be verified by relevant authorities.
– We call on the South Africans and medical professionals not to distribute or take the drug until its safety and efficacy is verified.
– The unregulated distribution of the drug can lead to sub-standard and falsified products that are harmful to human health.
– Ivermectin is registered in South Africa for the treatment of parasites in animals under the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act.
– There is currently no ivermectin-containing medicines registered for human use in the country.
– The efficacy, safety and the appropriate dosage for the use of ivermectin remains uncertain.
– SAHPRA noted that the overall quality of clinical trials of ivermectin in the treatment of COVID-19 patients is poor.
– Until evidence that is more robust is available, the use of ivermectin for COVID-19 cannot be justified.
All clinical trials on the drug are being closely monitored.
– The Access to COVID-19 Tools (ACT) Accelerator has commissioned a systematic review of available clinical trials evidence, but that process has yet to be concluded.
– More data is required from well-designed randomised clinical trials to demonstrate the safety of ivermectin.
– There are some larger clinical trials taking place and it is hoped that the results will become available within the first quarter of 2021.
– All current available data has been reviewed by the National Essential Medicines Committee COVID-19 Subcommittee and by SAHPRA.
Full IoL report
Full SAHPRA statement
Full government statement on Politicsweb site