Pfizer Inc. and BioNTech SE asked the US Food and Drug Administration to allow their Covid-19 vaccine to be stored for two weeks at temperatures found in normal pharmaceutical freezers, a change that could simplify distribution for the shot.
The partners submitted new data showing stability when the vaccine is stored at minus 25-to-minus 15 degrees Celsius (-13°F to 5°F), they said in a statement on Friday. Current protocol is for storage for up to six months in an ultra-cold freezer at temperatures of -80ºC to -60ºC and shipping in a special thermal container.
“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer Chief Executive Officer Albert Bourla said in a statement. The partners will keep looking for new formulations to make the vaccine easier to transport and use, BioNTech CEO Ugur Sahin said.
The cold storage necessary for messenger RNA vaccines is one complicating factor for vaccine rollout, particularly in countries without the necessary infrastructure. Vials of the Pfizer-BioNTech vaccine are shipped in a specially-designed thermal container, which if refilled periodically with dry ice, can be used as a makeshift ultra-cold freezer for as many as 30 days.
Vials of the Pfizer-BioNTech vaccine are shipped in a specially-designed thermal container, which maintains a temperature range of -90ºC to -60ºC and — if refilled periodically with dry ice — can be used as a makeshift ultra-cold freezer for as many as 30 days.
Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at 2⁰C to 8⁰C. The vaccine is administered at room temperature.
The partners said they will file the data to other regulators as well in coming weeks.