- SAHPRA says it will allow for use of ivermectin in compassionate-use cases
- These will be controlled, and closely monitored by relevant healthcare practitioners
- Guidelines for the exceptional-use programme will soon be released
The South African Health Products Regulatory Authority said on Wednesday that it will allow for use of ivermectin in the treatment of Covid-19, in exceptional circumstances, in a "controlled, compassionate, access programme".
The regulator said that the compassionate-use programme would be available to all patients, but applications will need to be done by healthcare practitioners, who will need to closely monitor the progress of the patient.
"We have listened, and we have heard," SAHPRA CEO Dr Boitumelo Semete-Makokotlela said in a press briefing.
She said the regulator was cognisant of the second wave, and understood the situation with practitioners, and the limited options available.
“We're putting in place a compassionate access program that will be controllable. We will communicate in an external with very clear guidelines in terms of what was going to look like.
"And again, we've considered the risk-benefit of having this product available. And again we will have to work very closely with the medical practitioners because they will be very important in their reporting,” Semete-Makokotlela explained.
Semete-Makokotlela says that this will fall under the body’s compassionate use programme that will be open to all patients but the healthcare professional will have to be the one who needs to apply for the use of the drug.
She says that this will help monitor the progress of the patient to see whether there are positive or negative outcomes.
The protocol guidelines will be published in the coming days.
Clinical trials are still needed
Semete-Makokotlela says that this does not mean that Sahpra has approved for the wider use of ivermectin, as the regulator still believes that there is not enough evidence that shows that the drug works against preventing or treating Covid-19.
She says that the body has consulted with its regulatory counterparts in other countries like the UK and US, who are also of the opinion that more evidence from clinical trials is needed to prove the efficiency of the ivermectin against Covid -19.
Semete-Makokotlela said Sahpra has also engaged with the World Health Organization, who also agree that current information is limited, on the use of ivermectin in Covid-19.
She did, however, acknowledge "positive trends" from studies being conducted, and that the regulator would continue to review available data.