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Pfizer and BioNTech announced on Friday that new data they presented to the United States Food and Drug Administration (FDA for its acronym) demonstrates the stability of your coronavirus vaccine when stored for two weeks at -25 ° C to -15 ° C, a typical range in pharmaceutical freezers and refrigerators. This would serve as an alternative or supplement to storage in an ultra-low temperature freezer, an obstacle that complicates the logistics for the application of this vaccine.
“Our top priority was to quickly develop a safe and effective vaccine and make it available to the world’s most vulnerable people to save lives. At the same time, we have continuously collected data that could allow storage at around -20 ° C. presented they can facilitate the handling of our vaccines in pharmacies and offer vaccination centers even more flexibility ”, underlined the CEO and co-founder of BioNTech, Ugur Sahin.
Currently, the vaccine data sheet states that it should be stored in an ultra-cold freezer at temperatures between -80 ° C and -60 ° C for a period of up to 6 months. Vaccines are shipped in a specially designed Pfizer insulated container that can be used as temporary storage for a total of up to 30 days, which should be filled with dry ice every five days. This makes it difficult for them to be transported to the less developed regions of the world and the least prepared to face the pandemic..
Before mixing with saline diluent, the vaccine can also be refrigerated for up to five days at standard refrigerator temperature, between 2 ° C and 8 ° C. Thereafter, the vaccine is administered at room temperature by patients. nurses.
The option of storing the vaccine at -25 ° C to -15 ° C for two weeks would be in addition to this five-day storage option at standard refrigerator temperature. The companies say they will present this data to the rest of the world’s regulatory agencies “in the coming weeks.”
“If approved, this new storage option would provide pharmacies and vaccination centers with greater flexibility in how they manage their vaccine supply. We continually conduct stability studies to support vaccine production on a commercial scale, with the goal of making the vaccine as accessible as possible. around the world, ”said Pfizer Chairman and CEO Albert Bourla.
As more data on the stability of their vaccine becomes available, Pfizer and BioNTech predict that the shelf life and / or expiration date “may be extended and the ability to store the vaccine at a temperature. short-term alternative could be considered ”.
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