No more ultra-cold freezers: Pfizer, BioNTtech submit COVID-19 vaccine stability data at standard freeze temperature to FDA

February 19, 2021  –  Pfizer Inc. and BioNTech SE announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators.

The data have been submitted 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.

Currently, the labels for the Pfizer-BioNTech COVID-19 Vaccine, including the EUA label in the U.S., state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to ‑76ºF). 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 2⁰C and 8⁰C (36⁰F and 46⁰F).

If approved, the option to store at -25°C to -15°C (-13°F to 5°F) 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.

As additional stability data are obtained, Pfizer and BioNTech anticipate the shelf life and/or expiration date could be extended, and alternate short-term temperature storage may be considered.

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