Pfizer/BioNTech have submitted new data to the US Food and Drug Administration (FDA) that demonstrates the stability of their COVID-19 vaccine at warmer temperatures.
Currently, the labels for the mRNA-based vaccine state that the jab must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC, where it can be stored for up to six months.
The Pfizer/BioNTech COVID-19 vaccine is shipped in a ‘specially-designed’ shipping container that can also be used as temporary storage for up to 30 days.
The vaccine can also be refrigerated for up to five days at standard refrigerator temperature (between +2⁰C and +8⁰C) before mixing with a saline diluent.
According to Pfizer/BioNTech, the new data demonstrates that their vaccine can be stored at temperatures of -25°C to -15°C, temperatures commonly found in pharmaceutical freezer and refrigerators.
If the FDA approves the updated prescribing information, this would allow the vaccine to be stored at these warmer temperatures for a total of two weeks, as an alternative or complement to storage in an ultra-low temperature freezer.
“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world,” said Albert Bourla, chairman and chief executive officer of Pfizer.
“We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centres greater flexibility in how they manage their vaccine supply,” he added.
An update to the current storage requirements for Pfizer/BioNTech’s vaccine would address certain limitations around the deployment of the jab.
It could allow the easier roll-out of the vaccine in countries which lack the infrastructure to support ultra-low storage temperatures, making distribution less of a concern.
In regards to the new storage data, a World Health Organization (WHO) spokesperson commented: “We are aware of reports of this and look forward to seeing the data. If proven correct, this could make roll-out of the vaccine easier in all countries, and particularly in low-income ones.”