COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Changes Storage Requirements for Pfizer COVID-19 Vaccine, Facilitating Faster and More Widespread Use

FDA maze of regulations

New storage requirement for Pfizer vaccine makes it easier for clinical laboratory personnel to access vaccine

The US Food and Drug Administration (FDA) announced changes to stringent storage requirements previously in place for the Pfizer COVID-19 vaccine. Previous guidelines required ultra-cold storage of the vaccine (temperature from -80°C to -60°C). These guidelines made transporting and storing this vaccine logistically difficult and slowed its initial role out.

New FDA guidelines now allow for storage at standard freezer temperatures for up to two weeks. While the colder temperature requirements did help maintain the vaccine’s stability for up to six months, the loosened requirements will make shipping and storing easy enough that the two-week timeframe should not significantly affect vaccine delivery and administration.

“Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get the vaccine to more sites,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.

As the Pfizer vaccine becomes more widely available and the US begins to reach herd immunity, COVID-19 testing volumes could be impacted. However, clinical laboratory staff will have improved accessibility to vaccines as well, and that could potentially reduce clinical laboratory staffing shortages.

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