Pfizer files to ease COVID-19 vaccine temperature storage requirements

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Pfizer has submitted data to potentially ease storage requirements for its COVID-19 vaccine. The company said the vaccine has demonstrated stability when stored at -25 degrees Celsius to -15 degrees Celsius, which is commonly found in pharmaceutical freezers and refrigerators.

Pfizer said it submitted the data to the FDA to support a proposed update to prescribing information, which would allow the vials to be stored at these temperatures for up to two weeks as an alternative or complement to using the ultra-low temperature freezer.

Under the current emergency use authorization, the vaccine must be stored in an ultra-cold freezer at temperatures between -80 degrees Celscius and -60 degrees Celscius, and can remain stored at these temperatures for up to 6 months. They are shipped in specially-designed thermal container that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. 

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Before being diluted, the vaccine may also be refirgerated for up to five days at standard refigerator temperature, and then must be administered at room temperature. 

The company said in a news release Friday, that if approved, the update would provide greater flexibility for shipping and distribution. 

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“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a news release. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their supply.” 

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