Pfizer Inc and partner BioNTech SE said on Friday they have submitted new data to the US health regulator showing the stability of their Covid-19 vaccine at temperatures commonly found in pharmaceutical freezers and refrigerators.
Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose vaccine, won the US emergency use authorization (EUA) and is being widely distributed as part of the country’s mass vaccination efforts.
If approved, the less onerous storage requirements would provide a big logistical relief because the vaccine for now has to be stored at minus 70 degrees Celsius for longer periods, a challenge particularly in lower-income countries that don’t have the ultra-cold-storage infrastructure.
Pfizer/BioNTech’s current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), calling for it to be shipped in specially designed containers.
The companies said the new data has been submitted to the US Food and Drug Administration to support a proposed update to the current EUA label, which would allow for vaccine vials to be stored at -25°C to -15°C for a total of two weeks as an alternative for storage in an ultra-low temperature freezer.