The Therapeutic Goods Administration has changed its storage conditions for the Pfizer vaccine, allowing the breakthrough vaccine to be stored longer at normal refrigeration temperatures, a move which could have a big impact on Australia's sluggish vaccine rollout.
When the Pfizer vaccine was first provisionally approved by the regulator earlier this year, the scientific evidence was that it needed to be kept at ultra-cold temperatures - below minus 70 degrees - until just hours before being injected. It was thought the vaccine wouldn't remain stable as the temperature rose, but more evidence has proven it remains safe and effective for longer out of the deep freeze.
"This change extends the approved storage period of the unopened thawed vial at 2-8 degrees (i.e. in a normal refrigerator after taking out of deep-freeze conditions) at the point of use from five days up to one month (31 days)," the statement from the Therapeutic Goods Administration said.
"The changed storage requirements will enable much greater flexibility in the distribution of the vaccine and have a significant impact on the roll out of the vaccine across Australia."
The decision follows similar decisions made in other countries around the world, including in Europe.
In the current phase of Australia's vaccine rollout, Pfizer vaccines are only being administered in state and territory vaccination hubs, and by federally-contracted health teams rolling out vaccines in residential aged care.
But come October, the role of Pfizer is expected to ramp up dramatically, becoming the main vaccine to be used for people aged under 50.
At the moment, general practices are only vaccinating people using the AstraZeneca vaccine. Before issues relating to a small risk of blood clots related to the AstraZeneca vaccine emerged, it was set to be the main element of Australia's vaccine rollout, largely because it didn't require the same ultra-cold storage as the Pfizer vaccine, making it an obvious choice for Australia's rural and regional communities.
But the new advice for the Pfizer vaccine gives the government more options for how it can be used, particularly in areas previously thought unsuitable.
In some areas of Australia, including parts of regional South Australia and regional Queensland, vaccination is being offered to everyone above the age of 16, regardless of age or medical condition, because of low population density.
Ahead of the official announcement, last week Health Minister Greg Hunt called the likely change to requirements a "gamechanger".
"[It] will see a fundamentally important thing happen," Mr Hunt told a conference of pharmacists.
"And so, we have supply and we have refrigeration, which means that we will be able to have a dual track program of our general practices and community pharmacies."
Pharmacies would be a fundamental part of the third phase of the rollout, he said.
Vice President of the Australian Medical Association Chris Moy said the change was positive for the rollout.
"It's a really positive bit of information for the reducing the logistical requirements of storage and transport for the Pfizer vaccine, but having said that, there's no urgency to change what's going on now with the rollout," he said.
Even though the government is receiving regular weekly shipments of the Pfizer vaccine from overseas, with more than 300,000 doses arriving earlier this week, Dr Moy said the supply of the vaccine was still the major limiting factor in how the vaccine was used.
"There's no point opening it up to more people," he said.
"We don't need any fast moves, just when we are getting in our groove [with the AstraZeneca vaccine rollout with GPs]."
Dr Moy said the changed storage conditions didn't automatically mean GPs should be added to the Pfizer rollout as well as the AstraZeneca rollout.
"It would be very hard to be alternating in one clinic for example," he said.
Under current rules, state and territory hubs using the Pfizer vaccine are not also using the AstraZeneca vaccine.
How the changed storage guidance would affect the Pfizer rollout, which is expected to ramp up later in the year, is a "discussion for later," he said.
The more urgent discussion was ensuring anyone eligible for a vaccine now got vaccinated as soon as possible, Dr Moy said.
ACT President of the Pharmacy Guild of Australia Simon Blacker said the change to guidance could make it easier for pharmacies to be part of the vaccine rollout across the country.
"The storage standards now allow community pharmacies to meet those requirements," Mr Blacker said.
There was no hesitation from pharmacies to get involved in the rollout, he said.
"There are 66 pharmacies in the ACT that has been informed they may be involved in the Covid vaccine rollout at some stage."
That means potentially three in four pharmacies in the ACT could be involved in the rollout, increasing accessibility and coverage for people to get vaccinated.
Acknowledging the tight supply for the Pfizer vaccine, Mr Blacker said making plans now would allow pharmacies to be completely ready to go when increased supply comes towards the end of the year.
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