Here’s What You Need To Know About The COVID-19 Pill Australia Just Purchased

The drug hasn't been approved in Australia, yet.

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The Federal Government is so keen on a potential new COVID-19 treatment that it has ordered 300,000 courses before the drug, molnupiravir, has even been approved for use in Australia.

Despite not yet receiving approval from the Therapeutic Goods Administration (TGA), major US drug company Merck is already claiming the drug could halve the chance of a patient being hospitalised or dying from COVID-19.

So what exactly is molnupiravir, how does it work, and when can we expect it to be used in Australia?

What Is Molnupiravir?

Molnupiravir — AKA ‘molnu’ — is an oral antiviral medication developed by Merck (the pharmaceutical giant that gave us GARDASIL and the NuvaRing). If approved, it will be the first medication of its kind for treating COVID.

The major benefit of molnupiravir over other COVID-19 treatments on the market today is that it is a pill, rather than an injection, and doesn’t require refrigeration. This means it is significantly easier to distribute and administer on a wider scale than other treatments like sotrovimab. Molnupiravir is a treatment, rather than a vaccine (like Pfizer and AstraZeneca) and works to limit the virus’ ability to replicate once you’re infected.

“It affects the ability of the virus to replicate,” Associate professor Sanjaya Senanayake, an expert in infectious diseases from the Australian National University told the ABC. “So in a sense, it causes the virus to produce unhealthy babies.”

This is different to antibody treatments (sotrovimab), which mimics the body’s natural antibodies to help fight off infected cells. Molnupiravir is taken twice a day for five days to treat patients with symptoms that aren’t severe enough to require hospitalisation.

Is It Safe?

At the time of publishing, molnupiravir has not been given formal or emergency approval anywhere in the world. So right now, we can’t confirm whether or not it is safe and we do not recommend self-medicating with it.

However, Merck and Ridgeback Biotherapeutics have some pretty promising trial data that has been enough to convince the Australian Government to stock up on supplies of the drug.

According to trial results, 7.3 per cent of patients were hospitalised and none died 29 days after finishing treatment. Comparatively, the hospitalisation rate of those given the placebo was almost double at 14.1 per cent, with eight fatalities.

While this is a great start, further testing is still needed. “The initial trial was quite small, with a few hundred people in each arm,” Dr Senanayake told the ABC. “So it would be good to get a better idea of a safety profile, but I will leave that in the capable hands of the TGA.”

Merck is currently seeking emergency authorisation in the US, but this is yet to be granted.

When Can We Expect It To Be Available For Use In Australia?

Molnupiravir has already been granted provisional determination by the TGA in Australia, which is the first of many steps needed to get the drug approved for regular use. The provisional determination was approved on August 9, 2021, with further consideration from the TGA scheduled for later in 2021.

According to Federal Health Minister Greg Hunt, we could expect the drug to be approved as early as next year. But despite this quick timeline, Hunt is confident the TGA’s testing will still be thorough.

“All COVID-19 treatment assessment processes are being treated with the greatest priority as part of the Government’s response to the pandemic,” Minister Hunt said in a press release on Tuesday.

“The TGA is allowing data on the safety and efficacy of COVID-19 treatments to be provided as it is available to allow for an early approval for use in Australia without skipping any steps.

There’s no word on exactly when it will be available for use in Australia, and it’s important to note that our deal is conditional on the TGA approval, but a statement from Prime Minister Scott Morrison has ball-parked that a “TGA approval and delivery of the treatment to the National Medical Stockpile would occur in early 2022.”

So Do I Still Need To Get Vaccinated?

Absolutely. Vaccines are still your best type of defence against COVID-19 — and our path out of the seemingly endless lockdowns. If you haven’t already, go and get the jab.

Think of this — if it’s approved — as a backup plan to help reduce the severity and fatality of COVID-19 in Australia. Vaccines will protect most of us, but this could help to reduce the strain on the hospital system, and treat milder COVID-19 symptoms.