Three new COVID treatments given provisional TGA approval

The Therapeutic Goods Administration (TGA) has provisionally approved two new oral treatments for COVID-19 in the hopes of bringing the Omicron outbreak under control. It has done the same for Novavax’s protein-based vaccine.

Provisional approval has been given for two COVID-19 pills that target the symptoms of the virus, with the aim of lessening their severity and dramatically reducing hospitalisations.

Lagevrio and Paxlovid are oral antiviral treatments that have been found to be effective in treating people with mild to moderate COVID who are at high risk of progressing to severe disease. Both pills work by disrupting the virus’s ability to replicate inside cells.

This results in a low viral load inside the body, which greatly reduces the risk of serious disease. It’s hoped the treatments can help ease the pressure of the nation’s hospitals and frontline staff.

Lagevrio, the brand name of the drug molnupiravir, was developed by American pharmaceutical companies Merck and Ridgeback Biotherapeutics. The pill works by flooding COVID particles with defective genes so that when they attempt to replicate, they cannot.

Lagevrio is recommended for those most at risk of developing moderate to severe symptoms.

Read: Pfizer boss warns vaccines not effective against Omicron

Paxlovid is manufactured by Pfizer and while it also affects the virus’s ability to replicate, it uses a different method.

The drug is designed to be taken as soon as possible after a positive COVID test, as it targets the virus before it begins replication. It blocks the SARS-CoV-2-3CL protease enzyme, which is vital for COVID to spread.

The federal government was quick to reassure voters that it had already obtained access to adequate supplies of the two drugs.

“The government has secured access to 300,000 treatment courses of Merck Sharp & Dohme’s (MSD) Lagevrio and 500,000 courses of Pfizer’s Paxlovid for supply throughout the course of 2022, with the first deliveries of both medicines anticipated over the coming weeks,” health minister Greg Hunt said in a statement.

“Lagevrio and Paxlovid will supplement the existing National Medical Stockpile supplies of Xevudy (sotrovimab) and Veklury (remdesivir) and future supplies of Evusheld (tixagevimab with cilgavimab), the later pending a final TGA decision on registration.”

Read: Outrage grows at COVID ‘pox parties’

Mr Hunt went on to say that while the approvals are good news, vaccination remains the most effective way to protect yourself against COVID-19.

Also granted provisional TGA approval was Novavax’s protein-based vaccine Nuvaxovid, the first protein COVID vaccine to receive approval in Australia.

Nuvaxovid is what’s known as a protein subunit vaccine. It is similar to a traditional viral vector vaccine, and works by introducing isolated proteins taken from cell walls inside the target virus (usually grown in a lab) to the immune system, in the hopes it will recognise the proteins as foreign and initiate a response.

Australia becomes just the second Organisation for Economic Co-operation and Development (OECD) nation to approve the Novavax vaccine, behind the European Union.

It has only been approved for use as a primary COVID vaccine, and not as a booster shot. The TGA says there is still not enough data to make a final call on boosters yet.

Read: RAT drought, yet Australian-made tests available overseas

Australia’s vaccination rate stands at around 95 per cent of the population over the age of 16 double dosed.

It’s hoped the Novavax approval might push that rate even higher, as some have been waiting for this specific vaccine.

“We know that some people have waited for Novavax and, although we’ve encouraged everyone to proceed, we recognise that that’s a fact,” Mr Hunt said.

“So hopefully this will encourage those people in that less than last 5 per cent to come forward. We want to have as many people [as possible] come forward to be vaccinated.”

Do you think the two new COVID pills will be a game changer? Has anyone you know been waiting for the Novavax vaccine? Let us know in the comments section below.

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Written by Brad Lockyer

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