FDA Authorizes Shelf-Life Extension for Pfizer COVID-19 Vaccine

4/13/22 — The FDA authorized a shelf-life extension for the two presentations of the Tris/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine, supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border. The authorization allows the frozen vials to be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. This extension was granted following a thorough review of data submitted by the manufacturer. Read the FDA authorization letter.