Pfizer/BioNTech Seek FDA Approval to Raise COVID-19 Vaccine Holding Temperatures
Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures.
If approved, the amended EUA would allow the vaccine to be stored at temperatures of -13 to 5 degrees Fahrenheit (-25 to -15 degrees Celsius) for two weeks.
The existing EUA stipulates that the Pfizer/BioNTech vaccine must be stored in an ultra-cold freezer at temperatures between -112 to -76 Fahrenheit (-80 to -60 degrees Celsius), but these very low temperatures pose a serious challenge for shipping and storage.
Under the current EUA, the vaccine must be shipped in special thermal containers that can keep the vaccine for up to 30 days, but this is only possible if dry ice is refilled every five days. Even with a revised EUA, the vaccines will continue to be shipped in the specially designed containers, which create distribution hurdles because the clock starts ticking as soon as vials are removed. The undiluted vaccine may also be safely stored under normal refrigeration for five days, in the range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).
Pfizer said the revised EUA request is based on stability data from vaccine batches produced over the past nine months. BioNTech said it initially imposed the ultra-low storage and shipping requirements because it only knew which of four vaccine candidates it would proceed with beginning in July, so it was late in starting the stability testing.
Moderna’s vaccine can be stored at regulator freezer temperatures for six months and at standard refrigerator temperatures for one month, while the Johnson & Johnson vaccine can be stored for up to two years in a standard freezer.
Pfizer and BioNTech have filed for the same shipping and storage requirements to the European Medicines Agency and plan to file with other global regulatory agencies within weeks. ― Jason Scott