When the COVID-19 pandemic started spreading beyond China’s borders and reached Australia early in 2020, the Australian Technical Advisory Group on Immunisation (ATAGI) decided to set up a COVID-19 working group.
No vaccines were in sight, although many were being developed. But it was already clear that a national COVID-19 vaccination campaign would be a tremendous task to accomplish.
Who should get immunised first? What would the rollout look like? And how to deal with the unknowns?
“The idea was to look at prioritisation, the design of the program, goals and aims,” says clinician scientist Professor Katie Flanagan, head of Infectious Diseases at Launceston General Hospital, Tasmania, and lead of the COVID-19 vaccine utilisation and prioritisation subgroup set up by ATAGI. “But also develop clinical guidance for clinical practitioners throughout the country, just like any other vaccine that’s administered in this country.”
A national immunisation handbook already exists, but the COVID-19 vaccination is a new, quickly evolving process that needs to be monitored as it unfolds.
“We are not ready to put it in as a finalised chapter to the handbook because it keeps changing,” says Flanagan. “But eventually, we will see COVID vaccines as part of the national immunisation program, I’m sure.”
Usually, when a pharma company develops a new vaccine, it lodges an application to ATAGI, which then evaluates the evidence and sets a policy.
But the complexity of the COVID-19 vaccine rollout requires a wealth of expertise. The scale of the undertaking is gargantuan, it involves vaccines never used before, and the epidemiology of the virus is dynamic.
“There is so much work to be done,” says Flanagan. “We’re starting from scratch with new vaccines, with data emerging weekly, so we really needed a specialised group that could work together and have all the right expertise all in one room.”
The working group includes mathematical modellers, epidemiologists, ethicists, GPs, immunologists, infectious disease experts and consumer representatives. The experts are divided into three subgroups. Subgroup 1, led by Flanagan, works on vaccine utilisation and prioritisation. Subgroup 2 works on the distribution plan, and subgroup 3 deals with safety, evaluation, monitoring and confidence.
Every subgroup analyses the scientific evidence that is constantly published, collects data and information released by other agencies worldwide and looks at international guidelines, from which they then draft guidelines and recommendations.
Every week, the subgroup leads meet with the National Centre for Immunisation Research and Surveillance, the government task force and other ATAGI representatives to discuss and approve the documents every subgroup has produced.
“That’s the process to develop the advice,” says Flanagan. “The government takes the advice, but they can choose to follow it or not.”
Initially, there were no data on vaccine efficacy and safety because trials were still ongoing, she explains. “We are learning about this virus in real-time. We are learning about these vaccines in real-time.”
Designing the COVID-19 vaccination rollout phases
“We went back to the principles that we wanted to guide us,” Flanagan says. “We looked at International guidelines and WHO recommendations. We used all the evidence coming out to try and figure out who might be more vulnerable to COVID. As the information came through, then obviously we could start feeding that into our decision-making.”
The ATAGI working group came up with three COVID-19 vaccination rollout phases that gave priority to those thought to be more at risk of infection, such as those working at national borders and health workers, and those more at risk of severe infection, such as the elderly and those with co-morbidities.
When the first prioritisation plan went out, many advocate groups appealed to ATAGI to be included in phase 1 of the rollout, says Flanagan. Consequently, all the medical peak bodies representatives were invited to discuss how to modify or broaden the priority groups.
“We have been very open, and we did adjust and tailor our advice based on many of the specialist societies feeding in and giving us their views on what might be a better definition for those that are more at risk,” she says.
The other variable that ATAGI experts must take into account is evolving epidemiology. Unlike other countries where the virus is rampant, Australia has almost no virus circulating in the community. But we’ve seen in all our major cities how a breach from the hotel quarantine system can quickly lead to an outbreak.
“We have got a different sort of risk/benefit decision to make,” says Flanagan. “It soon became obvious to us that our major risk was incursion through the borders. So border quarantine staff became the top priority, along with the frontline health-care workers, because of our particular epidemiology in Australia.”
When the evidence changes, the recommendation must adapt
When in March the first suspicious blood clots in people who had received the AstraZeneca vaccine were reported in Europe, the ATAGI called in the executive committee for an emergency meeting.
The European surveillance system had picked up some rare but severe adverse events that might have been linked to the vaccine. The European Medical Agency (EMA) opened an investigation, and the rollout was paused. Meanwhile, Australia was jabbing AstraZeneca vaccines into border staff and health workers.
As international agencies dug into the matter, it gradually became clear that a link between the vaccine and the rare blood clots does exist. Researchers discovered that the adverse event seems to be more prevalent in women under 50 years of age.
Considering that a considerable proportion of Australian health workers are women under the age of 50, the ATAGI could not overlook the new evidence.
“This was a huge decision to make for us,” says Flanagan. She says the COVID-19 working group was called to review the new information around these rare blood clots and consider changing vaccine recommendations.
If the virus were swiping through the country, the benefit of being immunised with the AstraZeneca vaccine would outweigh the minuscule risk of developing the rare blood clots, even in younger people, she explains. But for months now, Australia has really only recorded cases in hotel quarantine, and breaches have been controlled promptly.
ATAGI could not ignore the virtual absence of COVID in the community, says Flanagan: the recommendation for younger Australians had to change.
The changes have increased hesitancy towards the AstraZeneca vaccine and probably towards COVID-19 vaccines in general. “We absolutely knew this was going to lead to issues around hesitancy, and all we can do is to explain to people why that decision was made,” says Flanagan.
While Australians have the luxury of living in an almost COVID-19-free country – at least for now – the risk of outbreaks is real and permanent.
“What we do have to remember is that eventually we’re going to open our borders, and eventually every single person in Australia will get exposed to COVID,” Flanagan points out.