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Pfizer Submits Data Showing COVID-19 Vacccine's Stability At Standard Freeze Temperature

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that they have submitted new data to the U.S. Food and Drug Administration demonstrating the stability of their COVID-19 vaccine when stored at minus 15 degree celsius to minus 25 degree celsius, temperatures more commonly found in pharmaceutical freezers and refrigerators.

Currently, the labels for the Pfizer-BioNTech COVID-19 vaccine, including the Emergency Use Authorization label in the U.S., state that the vaccine must be stored in an ultra-cold freezer at temperatures between minus 60 degree celsius and minus 80 degree celsius. It can remain stored at these temperatures for up to 6 months

The vaccines are shipped in a 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. Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between 2 celsius and 8 celsius. If approved, the option to store at minus 15 celsius to minus 25 celsius for two weeks would be in addition to this five-day option to store at standard refrigerator temperature. The vaccine is administered at room temperature by medical staff.

The companies said they have submitted the data to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer. The data also will be submitted to global regulatory agencies within the next few weeks.

The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

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