FDA allows flexible storage and transportation conditions for Pfizer-BioNTech COVID-19 vaccine

Feb. 26, 2021

The U.S. Food and Drug Administration (FDA) 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, according to a news release.

This is an alternative to the storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), the agency said.

The FDA was responding to a request from Pfizer and BioNTech to allow this change by modifying the FDA’s emergency use authorization (EUA) for the companies’ vaccine.

“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

The FDA said Pfizer submitted data to the agency to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The FDA also said the alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days), or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours).

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