Pfizer-BioNTech’s current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between –80 C and –60 C, calling for it to be shipped in specially designed containers.
Now, new data has been submitted to the U.S. Food and Drug Administration to support a proposed update to its emergency use authorization label that would allow vaccine vials to be stored at –25 C to –15 C for a total of two weeks as an alternative for storage in an ultra-low temperature freezer.
If approved, the less onerous storage requirements would provide a significant logistical relief for the rollout of the vaccine, particularly in lower-income countries and remote regions that do not have the necessary infrastructure.
“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centres an even greater flexibility,” BioNTech chief executive officer Ugur Sahin said.
The Pfizer-BioNTech vaccine was approved by Health Canada on Dec. 9, 2020, and the first shots were delivered in Quebec and Ontario on Dec. 14, 2020.
It is not currently being administered in Yukon, N.W.T. or Nunavut because the territories lack the freezer equipment necessary to safely store it.
The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.
A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted