Updates to Storage Requirements for Pfizer COVID-19 Vaccine

February 25, 2021 – The U.S. FDA has relaxed temperature requirements for the transportation and storage of the COVID-19 vaccine from Pfizer and BioNTech. The vaccine can now be kept for up to two weeks at conventional temperatures of -25°C to -15°C (-13°F to 5°F) found in pharmaceutical freezers.

Pfizer and BioNTech’s product garnered media attention in late 2020 due to recommendations that it be stored at ultra-cold temperatures of -80°C to -60°C (-112°F to ‐76°F). These temperatures require specialized equipment to maintain for an extended period – equipment not all healthcare facilities and pharmacies have on hand. To support safe distribution of the product, Pfizer and BioNTech designed special dry ice shipping containers that can keep the vaccine at the required ultra-cold temperatures for up to 15 days if handled according to manufacturer instructions.

Easing temperature requirements for 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,” according to Peter Marks, M.D., Ph.D., and Director of the FDA’s Center for Biologics Evaluation and Research. The FDA based its decision on data from Pfizer demonstrating the stability of the vaccine at more conventional pharmaceutical freezer temperatures.

Additional information is available on the FDA’s website.