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The UK will be the first country to roll out a Covid-19 vaccine beyond stage-three clinical trials with 800,000 doses to be given to high-priority people, including healthcare workers and the vulnerable, from next week.
The Pfizer/BioNTech vaccine is the same one Australia will roll out from March. The two-shot vaccine is also being assessed by the US drug regulator, and a similar authorisation is expected to be made shortly for a rollout in mid-December.
Why, then, are Australian authorities saying the 10m doses of the vaccine it has secured will not be available until March?
Why is the UK distributing the vaccine so quickly?
The UK is still reporting more than 10,000 cases every day and is fast approaching 60,000 deaths, a very different situation from Australia where there has barely been any community transmission for more than a month. Many British hospitals are overwhelmed.
In Australia, as of 3 December, there were 13 active community cases – 10 in South Australia and four in New South Wales.
The UK has authorised the vaccine without complete data from clinical trials, which is still being assessed by Pfizer/BioNTech. That is why the UK decision is an emergency authorisation, not a full regulatory approval for distribution to everyone.
Given the situation is urgent in the UK, it makes sense to approve the vaccine for the elderly and health workers while regulators wait for the rest of the data. It’s a cost/benefit decision – waiting is likely result in thousands more deaths, and sick and furloughed health workers. The risk of an unforeseen, serious adverse reaction to the vaccine is low compared with the risk of many more people becoming infected and essential services reaching breaking point.
In Australia, teams of doctors, scientists, toxicologists, engineers, facility inspectors, pharmaceutical industry experts and other staff working with the Therapeutic Goods Administration are already looking at the available data, which amounts to tens of thousands of pages. Regulators expect to receive the full data by late January and will wait to analyse this as well.
The UK uses a catchment system to determine where citizens should seek medical treatment. Given its smaller geographical size, the logistics of large-scale vaccination will not be as complex. Even so, the UK prime minister, Boris Johnson, has said there will be “immense logistical challenges”, especially because the vaccine must be stored at minus 70C. Australia has time to sort out these logistics and learn from the UK’s experience.
“Any break in the cold chain can render a vaccine ineffective,” says Prof Lyn Gilbert, an infectious diseases physician on Australia’s infection control expert group. “We also need improved vaccine safety monitoring as these are brand new vaccines, and sometimes rare side-effects only become apparent post-licensure, because clinical trials may not be powered to detect very rare side-effects.”
Does this mean the UK is a guinea pig?
The vaccine has already been tested on tens of thousands of people in clinicial trials. And while the full data isn’t available, there is enough to have convinced UK regulators the vaccine is generally safe and effective, especially when weighed against the impact of the virus.
The CSIRO’s health and biosecurity director, Dr Rob Grenfell, says after stage-three clinical trials, drugs are usually rolled out in a “limited phase release” or a “limited community release” to certain population groups. “Regulators will watch what happens in that population carefully and they can stop the rollout at any time if they are concerned.” In the UK, the vaccine is first being given to groups well studied during clinical trials, such as elderly people and health workers.
A similar situation occurred in Australia for the Gardasil cervical cancer vaccine, which is now available worldwide. After stage-three trials, it was first tested in Australian girls and later boys, before being broadened to a national and then global immunisation program.
“If Australia can get this vaccine out by March that’s going to be the fastest it’s ever been done in this country,” Grenfell says. “The TGA should be allowed to have their independence to make decisions according to their own standards and timing, rather than have any external pressures because of what’s happening elsewhere.”
Isn’t it a risk for Australia to wait?
There is no regulatory process or law in Australia for an “emergency use authorisation” in the way that the UK and US have. In the UK, the Medicines and Healthcare products Regulatory Authority was given power to approve the vaccine by the government under special regulations. Regulators should only resort to such measures in extreme situations.
It will give Australians much more confidence in the vaccine if the TGA has time to examine the full dataset, and it will also give regulators more time to educate the public about the vaccine.
But there are other reasons to wait. The chair of epidemiology at Deakin University, Prof Catherine Bennett, says we will learn more about vaccine effectiveness in population subgroups in high-exposure settings such as the UK.
“We will hopefully be rolling out the vaccine in Australia with no community transmission, so it’s important to know it is working in the general population and we will only know that from similar countries that have the virus circulating at the time,” Bennett says.
“We talk about vaccine ‘efficacy’ under trial conditions but in the real world it is never as straightforward. Some people can’t or won’t want to be vaccinated. And with billions of doses being delivered there is a risk that some batches won’t work as well, or the cold chain will be broken if the vaccine is not kept at the right temperature and therefore won’t work in those recipients.
“What we learn about the vaccine effectiveness in other countries will help us to determine which vaccines we use for particular subgroups and make sure the logistics are designed to minimise any new risks.”
The head of the TGA, John Skerritt, says experts will be working through the holiday period to ensure the data analysis and safety approval is finished as quickly as possible.
“Our situation … is different from the UK,” he says. “By late January or February we will not only have the data from the clinical trials of 10,000 to 40,000 people, but we will also have the real-world experience of several hundred thousand people [in the UK] having had the vaccine.”
Does Australia’s government support the strategy?
The prime minister, Scott Morrison, said on Thursday Australia would not change its timeline based on UK regulators.
“In Australia we put our confidence in the Therapeutic Goods Administration … as we do not just on this vaccine but on every vaccine,” he said.
“It is about getting the balance right, on the timing, and there are lots of different views that you have to take into account to ensure the best health outcomes for Australians.”
Source: The Guardian
Keyword: The UK is about to start vaccinating against Covid-19. Why isn’t Australia? | Vaccines and immunisation