Pfizer presented data to potentially facilitate storage requirements for its COVID-19 vaccine. The company said the vaccine showed stability when stored at -25 degrees Celsius to -15 degrees Celsius, which is commonly found in freezers and pharmaceutical refrigerators.
Pfizer said it sent the data to the FDA to support a proposal to update the prescribing information, which would allow the bottles to be stored at these temperatures for up to two weeks as an alternative or supplement to the use of the ultra-low temperature freezer.
According to the current emergency use authorization, the vaccine must be stored in a deep-frozen freezer at temperatures between -80 degrees Celscius and -60 degrees Celscius, and can remain at these temperatures for up to 6 months. They are shipped in a specially designed thermal container that can be used as temporary storage for a total of up to 30 days, replenishing with dry ice every five days.
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Before being diluted, the vaccine can also be rehabilitated for up to five days at the refrigerator’s standard temperature and then it must be administered at room temperature.
The company said in a press release on Friday that, if approved, the update will provide greater flexibility in shipping and distribution.
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“We have been conducting stability studies on an ongoing basis to support vaccine production on a commercial scale, with the goal of making the vaccine as accessible as possible for healthcare professionals and people in the United States and around the world,” Albert Bourla, President of Pfizer and CEO, said in a press release. “We appreciate our continued collaboration with the FDA and CDC as we work to ensure that our vaccine can be shipped and stored in increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in the way they manage their supply. ”