Pfizer’s Paxlovid and Merck Sharp & Dohme’s Lagevrio are the first oral medicines for the virus to be provisionally approved for use in Australia by the Therapeutic Goods Administration (TGA).
Around 800,000 courses of the anti-viral pills are expected to arrive in the country in the coming weeks. Each medication is a five-day course, with pills taken twice a day, for people with a mild to moderate case of COVID-19.
According to the Federal Department of Health, initial supplies will be limited due to international supply chain constraints, and will therefore be prioritised to people with the highest clinical need.
Initial supplies of COVID-19 antiviral oral treatments will be made available through the National Medical Stockpile [NMS], as occurs with the current treatments.
Although they won’t be widely available in the short-term. They will be considered for use at an early stage of the virus in unvaccinated adults at risk at disease progression, and for the vulnerable such as those deemed ‘immunosuppressed or not immunocompetent’, or at ‘high risk of severe disease on the basis of age and multiple risk factors’, regardless of vaccination status.
Supplies will be delivered directly to residential aged care facilities and will also be made available to rural and remote communities, particularly in regions with high Aboriginal and Torres Strait Islander populations, via ‘state and territory distribution arrangements.
Both treatments were provisionally approved for use in COVID-19 patients aged 18 and over by the TGA last month. The TGA emphasised that these treatments are not a replacement for vaccinations. which remain the most effective way to prevent severe illness and death from COVID.
Either medicine should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms. They are designed to try and stop someone’s condition progressing to a more severe stage and work by interfering with the virus’s ability to multiply.
The Head of the TGA Professor Skerritt said the medicines were not suitable for all vulnerable groups, for instance they are not recommended for women of childbearing age who might be at risk of conception, who are pregnant or breastfeeding children or people with significantly impaired kidney or liver function.
Federal Health Minister Greg Hunt said patients would eventually be able to get the pills either through a prescription from their GP or in hospital. The Government is working with the companies on a Pharmaceutical Benefits Scheme (PBS) listing, which would allow widespread prescribing through general practice. In the meantime, there will be arrangements in each state and territory for access.
Australia already has two other treatments approved for use by the TGA, sotrovimab and remdesivir. Unlike Paxlovid and Lagevrio, they need to be administered intravenously by a healthcare professional.
Mr Hunt said the newly-approved medications complement these already available treatments.
For more information visit https://www.health.gov.au/health-alerts/covid-19/treatments/oral
