Additional COVID-19 treatment for Australia

Australians are set to have access to a new treatment for COVID-19, in addition to the continuously expanding vaccine rollout.

The Australian Government has secured an initial shipment of over 7,700 doses of the novel monoclonal antibody treatment sotrovimab. This treatment has been shown to dramatically reduce hospitalisation and risk of death in adults with mild to moderate COVID-19, who are at risk of developing severe COVID-19.

Sotrovimab will provide another tool in the ongoing challenge against COVID-19. It will provide an important new way to treat the disease and manage outbreaks across Australia.

Sotrovimab is currently being assessed by the Therapeutic Goods Administration (TGA) and will be available for use in Australia this year once the TGA evaluations are complete. As with all medicines, TGA approval is necessary for supply in Australia and once approved, doctors will be able to provide it to patients with COVID-19 who meet the terms of use recommended by the TGA.

The advanced purchase of sotrovimab has been supported by the Science and Industry Technical Advisory Group (SITAG), which is the Australian Government’s expert group advising on COVID-19 vaccine and treatment purchases.

Antibodies are proteins produced by our own body's immune system and are one of the main ways the body defends itself against diseases. Antibodies work by binding to a specific target – for example, a virus or a bacteria – and making them harmless. They block or slow down the action of the virus or bacteria, or they flag it as 'foreign' so that other parts of our immune system can clear the 'invaders' away.

Monoclonal antibodies work in the same way. They are laboratory-made proteins that mimic our body's immune system to help fight off harmful pathogens and can be used to help to treat people who already have COVID-19.

Monoclonal antibodies have been safely and effectively used to treat a growing number of diseases, some of which were difficult to treat in the past.

Manufactured by GSK, sotrovimab will be the first COVID-19 monoclonal antibody treatment available for use in this country, with the complete treatment requiring just one dose administered via IV infusion in a healthcare facility.

To date, the sotrovimab treatment has been shown to reduce hospitalisation or death by 79 per cent in adults with mild to moderate COVID-19 who are at high risk of progression to severe disease.

The Australian Government’s agreement with sotrovimab’s supplier GSK includes delivery of more than 7,700 doses for the National Medical Stockpile, with an initial delivery this year upon TGA approval.

As with all products procured for the National Medical Stockpile, this treatment will be provided to states and territories as needed, to be administered to eligible patients in a healthcare facility.

Not all people with COVID-19 will require access to this treatment. Where a doctor prescribes this treatment for their patients with mild to moderate COVID-19, who are at risk of developing severe COVID-19, it will be made available free of charge through the public health system.

Physician estimates of the Australian patient treatment population range from eight to fifteen per cent of patients who are SARS-CoV2 positive that would be considered at high risk of disease progression and would be recommended for treatment with sotrovimab, based on past and current experience of managing COVID-19 patients.

The Australian Government is committed to providing all Australians with access to safe and effective COVID-19 treatments as soon as available. As Australia looks to managing existing outbreaks in 2021 and beyond, the sotrovimab treatment will provide further options to protect vulnerable Australians at risk of developing severe COVID-19. It will add flexibility, provide early access, and broaden coverage.

The Australia Government continues to engage proactively with developers of other promising treatments for COVID-19.