Report: Pfizer asking FDA to let its COVID-19 vaccine be stored at higher temps
Pfizer and BioNTech have asked the Food and Drug Administration to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing for it to be kept in pharmacy freezers, according to a Reuters report.
An approval by the FDA could send a strong signal to other regulators around the world that may potentially ease distribution of the shot in lower-income countries.
The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vaccine vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.
The current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC(-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.
The shot's cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.
A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted, according to the report.
"The data submitted may facilitate the handling of ourvaccine in pharmacies and provide vaccination centers an even greater flexibility," BioNTech chief executive Ugur Sahin said.