Pfizer, BioNTech Ask FDA to Approve Easier Vaccine Storage

(Bloomberg) -- Pfizer Inc. and BioNTech SE asked the U.S. 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 minus-80ºC to minus-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. The partners will keep looking for new formulations to make the vaccine easier to transport and use, BioNTech CEO Ugur Sahin said.

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The cold storage necessary for vaccines using messenger RNA technology is one complicating factor for inoculation drives, particularly in countries without the necessary infrastructure. Vials of the Pfizer-BioNTech vaccine are shipped in a specially designed thermal container, which can be used as a makeshift ultra-cold freezer for as many as 30 days if refilled periodically with dry ice.

Moderna Inc.’s mRNA vaccine is stable at minus-20⁰C for as long as six months and can be stored at refrigerator temperatures for as many as 30 days. By contrast, the AstraZeneca Plc vaccine -- which uses a different technology -- can be stored at refrigerator temperatures for as long as six months.

Before mixing with a saline diluent, the Pfizer-BioNTech vaccine may also be refrigerated for as much as 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.

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