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FDA gives OK to refrigerate thawed, undiluted Pfizer-BioNTech vaccine for 1 month

May 20, 2021
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The Food and Drug Administration (FDA) authorized longer storage of undiluted, thawed Pfizer-BioNTech’s COVID-19 vaccine vials, a move intended to broaden dissemination of the vaccine in a variety of health care settings, including pediatricians’ offices.

According to an updated fact sheet for health care providers, undiluted, thawed Pfizer-BioNTech COVID-19 vaccine vials can be stored in the refrigerator at 2 to 8 degrees Celsius (35 to 46 degrees Fahrenheit) for up to one month. Previously, thawed, undiluted vaccine vials were approved to be stored at this temperature range for up to five days.

The FDA based the update on a review of data submitted by Pfizer Inc.

“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,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

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