A trial in Brazil on Ivermectin that went twice as long as the Pfizer study, with three times the number of participants showed a 44% reduction in risk of infection; 56% reduction in risk (sic) and a 68% reduction in risk of death. Given this is as high if not higher quality than the Pfizer trial where all data hasn’t been released and no active surveillance of trial group took place why isn’t the TGA allowing a safe drug to be used as an early treatment for Covid-19?

Question Number: 103
PDR Number: SQ22-000184
Date Submitted: 24/02/2022
Department or Body: Department of Health

In Australia, the decision by the Therapeutic Goods Administration (TGA) was not to ban ivermectin, but to restrict the prescribing by general practitioners to TGA-approved indications such as scabies and certain parasitic infections. Ivermectin can be used as an early treatment for COVID-19 if prescribed or authorised by a medical practitioner registered as a specialist in dermatology, gastroenterology and hepatology, infectious diseases, paediatric gastroenterology and hepatology or paediatric infectious diseases.

This restriction reflects that ivermectin is not approved for use for COVID-19 in Australia or in other OECD countries, and its use by the general public for COVID-19 is strongly discouraged by the World Health Organisation and the US Food and Drug Administration. In Australia, the National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, publish evidence-based guidelines to support healthcare professionals. Considering the entire body of evidence relating to ivermectin, the Taskforce strongly discourages the use of ivermectin for the prevention or treatment of COVID-19. The Taskforce continually update their guidelines based on emerging evidence, and both the guidelines and the evidence base relied upon are publicly available.

If a sponsor submits the appropriate evidence, such as data demonstrating the safe and efficacious use of ivermectin for the treatment of COVID-19, they can make an application at any time to the TGA to register their medicine on the Australian Register of Therapeutic Goods. Any application must include a comprehensive data package to support the medicine’s safety, quality, and efficacy for the intended end use. This long-standing and well-established process provides rigorous safeguards to ensure that Australians have access to safe, effective, and high-quality medicines. The TGA cannot compel a sponsor to make such an application.