Pfizer and BioNTech have requested the FDA to alleviate requirements for their vaccine to be stored at ultra-low temperatures. Approval may ease distribution in lower-income countries.
The companies have submitted new temperature data to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius for a total of two weeks. The current label requires temperatures between -80ºC and -60ºC, meaning it has to be shipped in specially designed containers.
If approved, the less onerous storage requirements would provide significant logistical relief.
Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -25 to -15 degrees Celsius.
