FDA Approves Pfizer’s Request to Raise 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 agency said Pfizer provided it with data convincing it that the Pfizer/BioNTech COVID-19 vaccine would remain stable at pharmaceutical freezer temperatures during a two-week timeframe.

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 (DID, Feb. 22).

“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.

According to the previous EUA, the vaccine once thawed can be stored under normal refrigeration temperatures for up to five days, between 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

Pfizer and BioNTech are now pursuing the same revised storage requirements from the European Medicines Agency and other global regulators. ― Jason Scott