The Food and Drug Administration (FDA) has authorized undiluted, thawed vials of the Pfizer-BioNTech COVID-19 Vaccine to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
The update is based on recently submitted data that demonstrated the stability of the undiluted, thawed vials of the vaccine for up to 1 month at refrigerator temperatures. Previously, the labeling stated that undiluted, thawed vials could be stored in the refrigerator for up to 5 days.
The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been updated to reflect the new storage conditions. The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for use under an Emergency Use Authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. The vaccine is administered intramuscularly as a 2-dose series (0.3mL each), given 3 weeks apart.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
FDA in brief: FDA authorizes longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 Vaccine prior to dilution, making vaccine more widely available. [press release]. Silver Spring, MD: US Food and Drug Administration; May 19, 2021.