FDA approves storing Pfizer vaccine at standard temperature

Pennlive.Com | Friday, February 26, 2021 8:49 a.m.

The FDA has given the OK for the Pfizer-BioNTech covid-19 vaccine to be kept at standard freezer temperatures.

The U.S. Food and Drug Administration has given approval for the Pfizer covid-19 vaccination to be kept at standard freezer temperatures, alleviating some of the storage and transportation issues and making it easier to get the vaccine in arms.

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. 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.

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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA said the undiluted frozen vials of vaccine can be stored at “conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.”

Previously, the vaccine had to be kept in a freezer with temperatures between -112 degrees to -76 degrees Fahrenheit.

The FDA said Pfizer has submitted data that shows the vaccine “remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature.”

Thawed vials can be held in the refrigerator for up to five days, which has not changed. Vials that have been thawed and diluted can be held at refrigerator temperature or room temperature for use within 6 hours.

The Johnson & Johnson vaccine, which is awaiting FDA approval, does not require ultra-cold storage and is only one shot. The Pfizer and Moderna vaccines require two shots.