In a laboratory in an industrial Canberra suburb, a worker sprays fake blood onto surgical masks to see how well they protect against blood. In another lab, a large machine is used to spray a fine, concentrated mist onto more protective types of masks to test their ability to shield against aerosols.
Thousands of masks have been tested like this at the Therapeutic Goods Administration headquarters since the beginning of the COVID-19 pandemic in January 2020. At its peak, it was occurring around the clock to ensure the personal protective equipment used by frontline workers would keep them safe from the coronavirus.
“We were running seven days a week, two shifts, because we just had so many masks to test,” TGA head Professor John Skerritt says.
Australia’s medical regulator has become a household name over the past year thanks to its work approving coronavirus vaccines. But as Professor Skerritt said earlier this year, approving the vaccines was just 20 per cent of its work.
“This place has got a lot more profile, for good or bad,” he said.
“I stand up in front of the media, but it’s really the people who are testing my mask who are doing the hard work in the background.”
The regulator opened its doors to The Sydney Morning Herald and The Age to show the work being done by 750 scientists, medical experts, engineers and pharmacists, but also former police officers, spies and lawyers.
“It’s not just a bunch of scientists,” Professor Skerritt says.
The TGA has an important role in compliance, ensuring products are not advertised incorrectly or misused, and helping crack down on black-market imports or backyard manufacturing.
But science is a large part of its job.
It regulates medical drugs and devices, as well as any cell or tissue technology. That covers hundreds of thousands of products, including asthma inhalers, surgical implants, dental crowns, ibuprofen, wound dressings and hand sanitisers – as well as test kits for the virus that causes COVID-19.
The regulator looks at products before they can be used but it also continues to monitor and research drugs and devices once they’re in use. Uniquely to the region, it is equipped with the laboratories and equipment to test medical devices and products itself.
“We’re probably seen in the top six or seven regulators worldwide, and that includes the fact that we’ve got a fully set-up laboratory,” Professor Skerritt says.
In its chemistry labs, all sorts of drugs are tested – from the ordinary to the illicit – to find their actual chemical composition. There’s an artificial stomach to test how well drugs are absorbed. Another room holds deceptively nondescript but expensive machines that can provide chemical fingerprints of the compounds in various drugs.
In engineering labs, it also tests more common products, such as condoms.
Professor Skerritt said ensuring they worked without leaking or breaking was vital during the HIV/AIDS epidemic from the mid-1980s. So the TGA got machines that tested them by inflating them with air to a certain point. It’s work that’s still done today, with condoms placed on a white stick inside a beige machine and inflated until they burst.
Two vaccines down, 15 to go
The COVID-19 pandemic has required a shift. With emerging technologies, including mRNA vaccines, come new tests.
Expert molecular biologists, virologists, biochemists and immunologists have been conducting about six different tests on the two approved COVID-19 vaccines (AstraZeneca and Pfizer), often working seven days a week to ensure their strict standards are met.
In cell culture labs, scientists grow cells to test the mRNA vaccines. Those vaccines work by giving cells the recipe to make a protein that the body will then make antibodies against. This provides the body with a shield against the virus.
The TGA’s experts monitor the cells, using special dyes and machines, to make sure that process works. It requires a specific type of expensive machine, and while the regulator already had one, Professor Skerritt says it made sense to purchase another.
“It’s almost inevitable that Australia will somehow have more capability to make messenger RNA vaccines (mRNA); and who knows, in a few years’ time it could be for flu or measles,” Professor Skerritt says. “So we need to be ahead of the game to have the technology to test these vaccines.”
Professor Skerritt, who worked in a lab himself for 20 years, stresses the process to develop these vaccines has not been rushed. Rather, it’s been the single most concentrated investment in research and development in the past 50 or 100 years, with the exceptions of perhaps world wars or the space race.
As the pandemic took hold, every major medical research facility and pharmaceutical giant in the world turned their minds to developing vaccines, aided by billions of dollars from governments.
“Anyone who was a reasonable quality medical scientist was pivoted to work on vaccines,” Professor Skerritt says.
“So yes, the timeframes were shortened, but you actually had tens if not hundreds of thousands of people working on these vaccines.”
So far, the TGA has approved two COVID-19 vaccines, but Professor Skerritt says that’s just the beginning of the regulator’s work on the pandemic.
“I drive my people mad by saying, ‘you’ve approved two vaccines, you’ve only got about another 15 to go’,” he says.
But it’s not just about vaccines. Professor Skerritt expects to see more treatments and medicines for the disease in the not-so-distant future.
“The next big thing for COVID, apart from more vaccines, will be a greater focus on medicines,” he says. “They’ll be all different sorts of medicines, all the medicines that require injection through to the medicines you’ll take as a tablet.”
Professor Skerritt expects treatments and tests will be created in the coming months and years – some more effective than others.
“People are interested in novel approaches, like can you have a machine in the corner of a room that will somehow kill the virus? We are already starting to be asked to look at some wild and wacky things like that too,” he says.
“But I do expect that the big focus of our work will be second and third-generation COVID vaccines and treatments.”
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