Pfizer/BioNTech Pursue FDA Approval to Raise COVID-19 Vaccine Storage Temperatures

Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures.

If approved, the amended EUA would allow the vaccine to be stored at temperatures of -13 to 5 degrees Fahrenheit (-25 to -15 degrees Celsius) for two weeks.

The existing EUA stipulates that the Pfizer/BioNTech vaccine must be stored in an ultra-cold freezer at temperatures between -112 to -76 Fahrenheit (-80 to -60 degrees Celsius), but these very low temperatures pose a serious challenge for shipping and storage.

Under the current EUA, the vaccine must be shipped in special thermal containers that can keep the vaccine for up to 30 days, but this is only possible if dry ice is refilled every five days. Even with a revised EUA, the vaccines will continue to be shipped in the specially designed containers, which create distribution hurdles because the clock starts ticking as soon as vials are removed from the containers.