Australia’s leading health professionals have allayed fears that coronavirus vaccines are being ‘rushed through’ unsafely, touting the nation’s approvals process as one of the world’s strictest.
Professor Paul Young is working on a COVID-19 vaccine with the University of Queensland and said rigorous testing is undertaken on vaccines in Australia, even before they move into trial phases.
“The green light to move into the first phase of human trials follows extensive pre-clinical testing,” Professor Young told The New Daily.
“All medicines including vaccines are required to have a clinical trial and be successful at every stage before they’re considered for future use.
“After phase one, we get the data and that’s reviewed by a separate ethics committee and that happens again with stage two and three.”
He said there was a growing belief that because a vaccine is being developed at record speed, it is unsafe.
But Australians should feel assured any vaccine released would meet the checks and balances.
“Usually they do take several years to make because the phases are planned independently. So if phase one is successful, then they’ll be the commencement of the next phase.
“But in this case, we have the resourcing and the funding to plan them concurrently.”
The fact the whole process was being planned at the same time, and manufacturers are already getting ready to produce it in large quantities, was the reason it would be quicker than other vaccines, he said.
“We haven’t omitted any steps. All the reputable vaccines will go through all those stages. The testing, the checks and balances will be done.
“The fact the scaling up of manufacturing is happening concurrently, it will shave years off the timeline.
“Usually it only happens upon obtaining the stage three data. But because we really need a vaccine, the scaling up of manufacturers will shorten the timeframe.”
Once a vaccine has been developed, it goes through a strict process before the Therapeutic Goods Administration signs off on it.
A spokesperson for the health department said the undertaking was a huge process and the whole safety profile of a vaccine will be analysed.
“For a vaccine to be registered in Australia, a sponsor (usually a pharmaceutical company) is required to submit a comprehensive developmental dossier, which consists of clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information,” they said.
Not all vaccines are created equal though – and the recent announcement from Russia that it was rushing through one sent shockwaves around the world.
But a spokesperson for the health department said each of the vaccines in trials were being monitored.
“We are actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world, and meeting with pharmaceutical companies to discuss progress and the application process,” they said.
“We are also part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines.”