March 02, 2021
The U.S. Food and Drug Administration (FDA) last week announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. Although the preferred storage of the undiluted vials in an ultra-low temperature freezer, the new alternative temperature for transportation and storage of the undiluted vials allows the vials to be transported and stored under more flexible conditions.
“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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,”
Pfizer Inc. submitted data demonstrating that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature.
For more information on the new alternative transportation and storage temperatures, see the updated Fact Sheets for Health Care Providers Administering Vaccine (Vaccination Providers) on the FDA website.