Pfizer Receives OK From FDA to Raise Its Vaccine Storage Temperature
The FDA has approved Pfizer’s and BioNTech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures.
The amended EUA means the vaccine can now be held at temperatures of -13 to 5 degrees Fahrenheit (-25 to -15 degrees Celsius) for up to two weeks. Pfizer’s ultra-cold temperature requirements had been creating major hurdles for shipping and storage.
“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The previous EUA had stipulated that the vaccine be stored in a specially designed container at ultra-low temperatures between -112 to -76 Fahrenheit (-80 to -60 degrees Celsius) and that it could only be stored for 30 days if dry ice around the containers was refilled every five days. The newly approved temperature specifications would not require Pfizer to ship and store the vaccine in specially designed containers.