FDA Authorizes Increased Storage Time of Thawed Pfizer/BioNTech COVID-19 Vaccine

Pharmaceutical Technology Editors

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

FDA announced on May 19, 2021 that it was authorizing extending the time undiluted, thawed Pfizer/BioNTech COVID-19 vaccine vials can be stored in the refrigerator at 2 0C to 8 0C to one month. The change comes after the agency reviewed data submitted by Pfizer that demonstrated vials of the vaccine remained stable for up to one month at refrigerator temperatures. Thawed, undiluted vaccine vials were previously stored in the refrigerator for up to five days. The European Medicines Agency also approved the extended refrigeration time period.

“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 the Center for Biologics Evaluation and Research, Peter Marks, MD, PhD, in a press release.

Source: FDA