Pfizer has submitted data to facilitate the storage requirements for its COVID-19 vaccine. The company said the vaccine has shown stability when stored at -25 degrees Celsius to -15 degrees Celsius, commonly found in pharmaceutical freezers and refrigerators.
Pfizer said it has submitted the data to the FDA to support a proposed update of the prescribing information, which allows the vials to be stored at these temperatures for up to two weeks as an alternative or supplement to the use of the freezer with ultra low temperature.
Under the current permit for emergency use, the vaccine must be stored in an ultra-cold freezer at temperatures between -80 degrees Celsius and -60 degrees Celsius, and can be stored for up to 6 months at these temperatures. It is sent in a specially designed thermal container that can be used for a total of up to 30 days as temporary storage by refilling with dry ice every five days.
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Before diluting the vaccine, it can also be cooled to standard temperature for up to five days, after which it must be administered at room temperature.
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“We are constantly conducting stability studies to support the commercial production of the vaccine, with the aim of making the vaccine as accessible as possible to healthcare providers and people across the US and around the world,” said Albert Bourla, chairman of Pfizer and CEO, said in a news release. “We appreciate our ongoing collaboration with the FDA and CDC, as we work to ensure that our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option offers pharmacies and vaccination centers greater flexibility in handling their stock. ”