Pfizer Inc. recently submitted some data to the FDA to demonstrate that undiluted, thawed vials of its COVID-19 vaccine are stable at refrigerator temperatures for up to one month. Based on a review of the data submitted by Pfizer Inc., later, the U.S. Food and Drug Administration has authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days.
Commenting on the authorization, Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, said, “Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures. This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine.”
