Said Rees: “We are acutely aware that we don’t have many options for acute treatment, and we are very sensitive to what is at stake.”
Sahpra CEO Boitumelo Semete said: “We have listened, and we have heard. We have engaged with the scientific community and others on this very pertinent matter. We are very cognisant of the second wave, and some of us within the regulator itself have been affected and lost family members, so we understand the position the health-care practitioners are coming from.”
However, she added, the evidence that existed was “very limited” and that more data was needed before authorisation beyond the programme was put in place.
Unlike in other countries, Ivermectin is not registered for human use in SA. In those other countries it is being used “off label”, she explained.
Sahpra has, according to Rees and Semete, engaged with the World Health Organisation and regulators in other countries, such as the FDA and European Medicines Agency. These organisations have “indicated a very similar position to ourselves – that there is not yet sufficient and robust data for a regulator to make a decision and that the current studies that are ongoing need to continue”.
Ivermectin gets partial greenlight to fight Covid
Decision comes as many doctors call for it, but health products regulatory authority says better data needed to establish safety, doses and efficacy
The SA Health Products Regulatory Authority (Sahpra) announced on Wednesday that it had authorised a limited “compassionate and controlled access programme” for Ivermectin to be used to treat Covid-19.
To date, the drug is not authorised for human use in SA.
Prof Helen Rees, chairperson of Sahpra, said there was not yet sufficient data to indicate a full authorisation of the drug for human use, but that the programme put in place would “give respite while we wait for better data”. And, she said, it would at least ensure the quality of the product was of a high standard, which isn’t always the case with products imported on the black market.
She added: “We desperately need decent data so we can tell the community if it’s a good idea or not whether for prophylaxis or treatment.”
Detailed guidelines for what this controlled access would entail will be revealed later in the week and will “evolve” as data emerges. But in general, a controlled access programme is limited access to a product for people with serious or life-threatening conditions while clinical trials are still ongoing.
Said Rees: “We are acutely aware that we don’t have many options for acute treatment, and we are very sensitive to what is at stake.”
Sahpra CEO Boitumelo Semete said: “We have listened, and we have heard. We have engaged with the scientific community and others on this very pertinent matter. We are very cognisant of the second wave, and some of us within the regulator itself have been affected and lost family members, so we understand the position the health-care practitioners are coming from.”
However, she added, the evidence that existed was “very limited” and that more data was needed before authorisation beyond the programme was put in place.
Unlike in other countries, Ivermectin is not registered for human use in SA. In those other countries it is being used “off label”, she explained.
Sahpra has, according to Rees and Semete, engaged with the World Health Organisation and regulators in other countries, such as the FDA and European Medicines Agency. These organisations have “indicated a very similar position to ourselves – that there is not yet sufficient and robust data for a regulator to make a decision and that the current studies that are ongoing need to continue”.
While detailed guidelines are to follow, it has already been stated “there won’t be priority recipients” and that Sahpra “will look at every application”.
In the meantime, “larger, better randomised trials are needed” to boost the data.
This comes in the wake of polarised opinions on the drug. Some science experts say it should be urgently authorised, while others say it is not safe at the doses needed to fight Covid-19, and there are those who say we at least need to prepare for rollout before full authorisation takes place so we aren’t caught on the back foot when the greenlight is given.
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