FDA authorizes storing thawed Pfizer COVID-19 vaccine in refrigerator for up to 30 days before diluting

May 20, 2021 - 02:57 PM
FDA product update

The Food and Drug Administration yesterday authorized storing thawed, undiluted vials of the Pfizer COVID-19 vaccine at refrigerator temperatures (35°F to 46°F) for up to 30 days after the company submitted data showing the vials can remain stable that long, up from the previously authorized five days. For details, see the updated fact sheet for health care providers administering the vaccine. 

Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research, said the change should make it easier for vaccine providers such as doctors’ offices to administer the vaccine. 

Once the thawed vials are diluted, providers must use them within six hours, a potential challenge for clinicians who lack sufficient demand for the vaccine during regular office visits. 
 

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