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QUESTION ON NOTICE

Question:

24 February 2022

62. Why is Ivermectin banned as a Covid treatment when in the last year it has had a fraction (5) adverse event reports v over 100 adverse event reports from other early treatments such as remdesivir and dexamethasone for example? 63. Why was Remdesivir approved on the basis on a small number of trials with a small sample size? 64. Given the large number of people who have taken Ivermectin in the last six months in treating Covid and the low rate of adverse events in comparison with the Vaccines how can the TGA justify their decision to ban doctors prescribing Ivermectin? 65. Are doctors using Ivermectin in Australian hospitals to treat patients with late stage Covid? 66. If so why can’t Ivermectin be used as an early treatment? 116. Why is the TGA relying on real world data for children, spanning a few months but ignoring real world data on ivermectin that spans over 30 years. 117. According to the TGA search facility there has only been 5 reports of Adverse events against Ivermectin in the last 13 months. Given there has been over 108,000 adverse events against the Covid vaccines why is the TGA claiming that Ivermectin is not safe, when there has been so many more reported events from the Covid vaccines?

Answer:

Question Number: 133
PDR Number: SQ22-000119
Date Submitted: 24/02/2022
Department or Body: Department of Health

Answer to Questions 62, 64, 65, 66 and 117:

The prescribing of Ivermectin is not banned in Australia. General practitioners (GPs) can prescribe ivermectin for the treatment of scabies and certain parasitic infections as these indications have been approved by the Therapeutic Goods Administration (TGA). Ivermectin can also be prescribed for unapproved indications, such as the prevention and treatment of COVID-19, however such off-label prescribing must now be under the supervision of an appropriate specialist clinician, for example an infectious diseases specialist.

The restrictions were introduced in response to increases in off-label ivermectin prescribing for COVID-19, which posed a significant public health risk. The doses of ivermectin reported as being used for the treatment of COVID-19 were significantly higher than those approved for use by the TGA. Insufficient safety data exists for these higher dose levels and there have been hospital presentations in Australia and the US following use of ivermectin for COVID-19.

In addition, a significant concern was the likelihood that people who have been prescribed ivermectin may believe themselves to be protected from the disease and not get vaccinated or tested or seek appropriate medical care if they developed symptoms. This also poses a risk to the community through the spread of the disease as well as risks to individuals using it for this purpose.

In relation to the potential benefit of ivermectin, it is not approved for use for COVID-19 in Australia or in other comparable developed countries, and general public use for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organisation and the US Food and Drug Administration. Historical clinical data regarding the safety and efficacy of ivermectin pertains to its use for the treatment of TGA-approved indications. As yet, there is insufficient equivalent data available to indicate the effectiveness and safety of ivermectin for the treatment of COVID-19.

Answer to Q63

The TGA rigorously assesses COVID-19 treatments for safety, quality and efficacy before they can be used in Australia. COVID-19 treatments receive the same high level of scrutiny as other prescription medicines and related therapeutic goods.

Clinical trials are a key part of the scientific evidence that the TGA reviews during the assessment of a new treatment. Trials must be well-designed, of a sufficient length with a sufficient number of people who represent the people for whom the treatment is intended.

In addition, all clinical trials must comply with the Guideline for Good Clinical Practice to ensure that the results are credible and obtained ethically in the setting of informed consent where the rights of trial subjects are protected.

Data from ten clinical studies was included in the application submitted to the TGA to provisionally register remdesivir (VEKLURY). These studies included:

• Five studies in individuals with COVID-19:
o CO-US-540-5776 (Adaptive study)
o GS-US-540-5773 (Phase III study)
o GS-US-540-5774 (Phase III study)
o IN-US-540-5755 (patient compassionate use program)
o CO-US-540-5758 (Phase III study)

• Four studies in healthy participants:
o GS-US-399-1812 (Phase I study)
o GS-US-399-1954 (Phase I study)
o GS-US-399-4231 (Phase I study)
o GS-US-299-5505 (Phase I study)

• One study in patients with Ebola Virus Disease:
o CO-US-399-5366 (Phase II/III study).

Further details about these studies are publicly available in the Australian Public Summary Report for VEKLURY (remdesivir), which is available on the TGA website at: www.tga.gov.au/sites/default/files/auspar-remdesivir-200720.pdf

Answer to Q116

It is unclear what therapeutic good and what real-world data for children this question is referring to. There is no real world or other data for use of ivermectin for COVID-19 “spanning over 20 years”.