![]() 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. 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 have been submitted to the FDA to support a proposed update to the U.S. ![]() Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25☌ to -15☌ (-13☏ to 5☏), temperatures more commonly found in pharmaceutical freezers and refrigerators. ![]() (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. NEW YORK and MAINZ, GERMANY, FebruPfizer Inc.
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