Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the FDA
Pfizer Inc. and BioNTech SE announced the submission of new data to the 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.
The FDA submission includes stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development, from the batches that supplied the earliest clinical trials through the commercial scale batches currently in production. These data also will be submitted to global regulatory agencies within the next few weeks.