'Game-changing' pill for Covid-19 no substitute for vaccine, Australian officials say

Several countries including the US and South Korea are reviewing the drug for general use

Molnupiravir – a pill for Covid-19 hailed by the chief medical adviser to the US president Anthony Fauci, as a “profound game-changer”, can cut the risk of serious illness or death by half in adults with mild-to-moderate Covid-19 symptoms.

That is what the company’s clinical trials have found and the data is now under review by several drug regulators. The pill, made by pharmaceutical giant Merck, could be crucial for taking pressure off overstretched health services around the world.

The Australian government has been particularly keen on securing the drug, and announced a supply agreement with Merck this month for 300,000 doses.

Australian officials are cautiously optimistic.

But they said this week that while treatments for Covid-19, including Molnupiravir, can play “an important part” in their pandemic strategy, vaccination remains the foundation stone of efforts to protect the public while reopening the country.

A representative for the national health department told The National that it was important to understand that Molnupiravir was "not a vaccine” and was intended to treat people with “mild-to-moderate symptoms”.

Vaccination's record of success

“Vaccination remains the most important and safest way for Australians to protect themselves and their loved ones from Covid-19. Covid-19 treatments, such as Molnupiravir, Remdesivir and Sotrovimab provide additional tools to help manage the ongoing challenge of Covid-19,” the national health department said.

The representative said a number of elements made up a “broader strategy to address the public health issues associated with Covid-19 and boost the National Plan to safely reopen Australia and keep Australia safely open”.

Australia’s most populous state, New South Wales, is set to largely lift restrictions as its vaccination rate is expected to hit 80 per cent by October 19 and daily case numbers dropped below 500 on Sunday.

In Victoria, the other Australian state with major Covid restrictions currently in place, almost 2,000 new cases were reported on Sunday, but vaccination figures have been surging and the state expects 80 per cent of the people to become fully vaccinated by November 6.

A representative for the Australian Medical Association told The National that while “news of any promising new therapies is always welcome” … “nothing on the horizon is anywhere near as effective as vaccination”.

“Vaccination offers the best protection from serious illness and is much better than the alternative of being taken to hospital and having to receive round the clock care, including the latest medications.

“New therapies that are developed will still need TGA approval and, while they can complement vaccination, they are not a substitute,” they said.

The Therapeutic Goods Administration (TGA) is the Australian government regulator of medications and treatments. In the US, the Food And Drug Administration (FDA) is looking at the data Merck has supplied on their Covid pill clinical trials before emergency approval for use can be granted.

Almost 62 per cent of Australians over the age of 16 are fully vaccinated against Covid-19, roughly 50 per cent of the overall population.

But full vaccination rates remain relatively low in some states, such as Western Australia, that have had very few Covid cases over the course of the pandemic.

However, about 80 per cent of Australians have received at least one vaccine dose, and with vaccination hesitancy in Australia at low levels, the country is on target to fully vaccinate 90 per cent of its population.

Australia has largely been a pandemic success story, with slightly more than 1,400 deaths from coronavirus in a population exceeding 25 million people.

At the same time, the country’s strict international border controls and prohibitively expensive hotel quarantine system has kept some families apart for 18 months, as well as dealing a major financial hit to the country’s universities and other sectors.

The use of lockdowns to suppress outbreaks has increasingly been a subject of fierce debate.

Molnupiravir, sponsored by Merck Sharp and Dohme Australia Pty Ltd, was granted provisional determination by the TGA in August, first step in the process that enables the sponsor to apply to the TGA for provisional registration in the Australian Register of Therapeutic Goods.

The drug is being evaluated by the TGA in a rolling review, which means data is evaluated as it comes to hand. The TGA will only be in a position to make a regulatory decision once all required data is submitted by the sponsor.

Once the TGA approves the drug – and only then, delivery of the pill is expected in Australia in early next year.

Updated: October 11th 2021, 5:16 AM
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