The Food and Drug Administration (FDA) announced that 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.
The FDA continued:
· Based on a review of recent data submitted by Pfizer Inc., the FDA is authorizing 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.
· Pfizer Inc. submitted 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.
· The updated Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) is intended to help frontline workers understand the revised storage time. The Fact Sheet is available on the FDA’s web site.
· Emergency Use Authorization for Vaccines to Prevent COVID-19
