FDA adds more flexible storage, transportation alternative for Pfizer-BioNTech COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) announced this week that undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine will now be allowed to be transported and stored at conventional pharmaceutical freezer temperatures for up to two weeks.

While the preferred storage for this particular vaccine remains at extremely cold temperatures between -112 degrees Fahrenheit to -76 degrees Fahrenheit, this change allows short-term arrangements for undiluted vials. Thawed vials can be stored in the refrigerator for up to 5 days before dilution, while thawed vials after dilution can only be stored at refrigerated or room temperatures for up to six hours.

“This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions,” said Dr. Peter Marks, 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.”

The decision was based on new data submitted to the FDA by Pfizer Inc. That data showed that its COVID-19 vaccine can maintain stability after storing undiluted vials for up to two weeks at standard freezer temperatures.