Broader storage conditions for Pfizer vaccine bring GPs into the fold

The Therapeutic Goods Administration (TGA) has joined regulators in the US and Europe in approving storage of Pfizer’s COVID-19 vaccine at domestic freezer temperatures.
 
Announced late last week, the changes will enable ‘greater flexibility in storage, transport and deployment’ of the mRNA vaccine across Australia, the regulator said.
 
Chief Medical Officer Professor Paul Kelly said the announcement is ‘really good news’ following the Federal Government’s decision to broaden its recommendation for use of the Pfizer vaccine for people under the age of 50, and says it opens up the opportunity to bring GPs on board.
 
‘In terms of the rollout through GPs, we’re certainly putting that into the mix,’ he said on Monday.
 
‘[The vaccine] can remain very stable at -20°C, which is a normal freezer temperature, and for a period in a normal fridge temperature as well. So that opens up the possibilities for using Pfizer more generally and more broadly than we had first envisaged.
 
‘So that will go into the mix with these other things and those plans will continue.’
 
According to the TGA, unopened vials of the Pfizer vaccine are now permitted to be stored and transported at between -25°C to -15°C for up to two weeks. Vials stored or transported in this manner can also be returned to ultra-cold, longer-term storage between -90°C and -60°C within the original shelf life of the product.
 
Unopened vials can also be stored at domestic refrigerator temperatures, between 2°C and 8°C, for up to five days. Within this five-day period, a maximum of 12 hours can be used for transportation of the vials at refrigerator temperatures; however, the time used for transport counts against the five-day limit.
 
Once the vaccine has been opened and diluted with saline, either vials or syringes can be stored or transported at room temperatures of up to 30°C for up to six hours.
 
But the TGA notes that the vaccine should not be re-frozen once the vials have been thawed.
 
Meanwhile, if unopened vials are to be stored long term, the original storage requirements regarding dry ice or ultra-cold temperatures between -90°C and -60°C remain in place.
 
While some logistical concerns remain for rural and remote parts of the country, the greater flexibility in storage and transportation has been welcomed.
 
The initial plan to overcome cold chain challenges was to use ‘sophisticated eskies’ designed by Pfizer and BioNTech that could last for up to 14 days, and could hold between 1000–5000 doses.
 
The Australian Government last week increased its agreement with Pfizer for an additional 20 million doses after it announced it would overhaul its COVID-19 vaccination plans.
 
A Pfizer spokesperson told newsGP the 40 million doses will be made available ‘over the course of 2021’.
 
However, Professor Kelly said exact dates would be subject to the international market.
 
‘We’ll keep working with Pfizer to make it as quickly as possible,’ he said. ‘But that’s the agreement, whether it’ll be December or October I’m not going to speculate on that at the moment.’
 
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COVID-19 Pfizer rollout storage vaccine