Question Number: 163
PDR Number: SQ22-000147
Date Submitted: 24/02/2022
Department or Body: Department of Health
The Department of Health and Aged Care funds the National COVID-19 Clinical Evidence Taskforce, which is continuously identifying and analysing research on various treatments for COVID-19 in order to provide national evidence-based guidelines for the clinical care of people with COVID-19 (www.covid19evidence.net.au). The recommendations and their rationale, as well as clinical flowcharts for the management of COVID-19, are on our website.
Only vaccines and treatments that have been rigorously assessed and approved by the Therapeutic Goods Administration (TGA) to meet certain safety, quality and effectiveness standards may be supplied in Australia.
Treatment options for COVID-19 are complex with numerous therapeutic approaches targeting different stages of the disease, and are based on broad approaches such as anti-viral therapies, immune modulators, anti-inflammatories and convalescent plasma therapies.
Treatments are not a substitute to vaccination, as vaccination remains the most effective way to protect Australians.
To date, the TGA has granted provisional approval a number of COVID-19 treatments and medicines, including:
• tixagevimab and cilgavimab (EVUSHELD®), two separate, sequential injections of two long-acting monoclonal antibodies for the pre-exposure prophylaxis for COVID-19 in people who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine or COVID‐19 vaccine component.
• molnupiravir (LAGEVRIO®), an oral antiviral treatment, approved for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death. for the adults with COVID-19 not requiring supplemental oxygen and at a high risk of being hospitalised.
• PAXLOVID®, an oral COVID-19 treatment of nirmatrelvir and ritonavir, approved for the treatment of COVID-19 in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19, and are at increased risk of progression to hospitalisation or death.
• remdesivir (VEKLURY®), an intravenous infusion treatment, approved for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.
• sotrovimab (XEVUDY®), a monoclonal antibody treatment, approved for the treatment of adults and adolescents (aged 12 years and over, weighing at least 40kg) with COVID-19 who do not require initiation of oxygen due to COVID-19, and who are at increased risk of progression to hospitalisation or death.
• RONAPREVE®, a combination of two monoclonal antibodies – casirivimab and imdevimab, approved for the treatment of COVID-19 in adults and adolescents aged 12 years and older and weighing at least 40kg who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.
• tocilizumab (ACTEMRA®), a pre-existing monoclonal antibody treatment, previously approved for the treatment of various types of arthritis and inflammatory conditions, was approved for the intravenous treatment of confirmed COVID-19 in hospitalised adults aged 18 years and older who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation designed to reduce inflammation.
• regdanvimab (REGKIRONA®), a monoclonal antibody treatment, approved for the intravenous treatment of mild-to-moderate COVID-19 in adult patients who are confirmed to be infected with the SARS-CoV-2 virus.
Additional information on the provisional approval of COVID-19 treatments can be found at: www.tga.gov.au/covid-19-treatments-provisional-registrations.
The details of the Advance Purchase Agreement (APA) with Pfizer for the purchase of their COVID-19 vaccine are commercial-in-confidence.
The TGA assesses and approve treatments for COVID-19 for use within Australia that have had a formal application made to them. COVID-19 treatments that are currently approved can be found at: www.tga.gov.au/covid-19-treatments-provisional-registrations.
