February 19, 2021
Pfizer and BioNTech are asking the U.S. Food and Drug Administration to allow their COVID-19 vaccine be stored in standard pharmaceutical freezers, a change that could significantly simplify distribution efforts.
The companies have submitted data showing their vaccine remains stable when stored for two weeks at temperatures between -13 degrees and 5 degrees Fahrenheit.
The FDA's emergency use authorization currently requires the vaccine to be stored at -112 to -76 degrees — temperatures that require ultra-cold freezers. It also must be transported in specialized thermal containers.
"If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply," Pfizer CEO Albert Bourla said.
The storage challenges were among the reasons the pace of vaccinations got off to a slow start in the United States. The process has sped up, but the increased storage flexibility could further aid the rollout.
President Joe Biden pledged to administer 100 million shots in his first 100 days in office and the U.S. has nearly caught up to the pace it needs to be at in order to achieve that goal, The Washington Post reported.
Nearly 1.5 million shots were administered each day over the past week. However, with more contagious variants spreading across the country, health experts are pushing the administration to over deliver on its promise.
The temperature requirements of the Pfizer vaccine also are a barrier to vaccine distribution in countries without the necessary equipment. Pfizer and BioNTech said they plan to submit their data on the vaccine's stability to global regulatory agencies in the coming weeks.
The specialized thermal containers used for distribution also can double as a storage freezer for up to 30 days when refilled with dry ice every five days, according to the companies. The vaccines can be refrigerated for up to five days in standard refrigerators between 36 and 46 degrees.
Moderna's COVID-19 vaccine — the only other one authorized by the FDA — can be stored for six months at -4 degrees. It can be kept in a refrigerator for up to 30 days.
The FDA will consider authorizing Johnson & Johnson's COVID-19 vaccine later this month. That vaccine, which requires a single shot, can be stored in standard refrigerators. So can a vaccine developed by AstraZeneca, which has been approved by several countries but is currently undergoing Phase 3 trials in the U.S.
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