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
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July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
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