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Proposed U.S. EUA label update would enable the vaccine to be stored at -25°C to -15°C (-13°F to 5°F) for a total of two weeks
If approved, new storage option could offer pharmacies and vaccination centers greater flexibility in managing and maintaining vaccine distribution and supply
NEW YORK and MAINZ, GERMANY, February 19, 2021 (GLOBE NEWSWIRE)
BioNTech SE (Nasdaq: BNTX) today 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.
Scaling up production of formerly niche substances such as lipid nanoparticles for a global vaccine drive has been among the most complex challenges behind the effort.
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