Pfizer and BioNTech, a German biotech company, have applied to the U.S. Food and Drug Administration (FDA) for a change in storage conditions for their Wuhan pneumonia (novel coronavirus disease, COVID19) vaccine, requesting approval to store it at a higher temperature, i.e., -15 to -20 degrees Celsius, for 2 weeks.
This storage condition is much more relaxed than the previous requirement of -60 to -80 degrees Celsius ultra-low temperature environment. If the FDA approves the change, it will not only help alleviate the problem of domestic vaccine distribution in the United States, but also reduce the difficulty of distribution to low-income countries.
Pfizer said on the 19th that it has submitted new information to the FDA to support the vaccine’s stability at -15 to -20 degrees Celsius, and that the relaxed storage requirements will allow the vaccine to be stored in freezers commonly found in pharmacies. Albert Bourla, the company’s chief executive, said in a statement that if approved by the FDA, “the new storage option will give pharmacies and vaccination centers greater flexibility in managing vaccines.
The FDA’s current storage requirements for Pfizer/BioNTech vaccines are -60 to -80 degrees Celsius for up to six months and dry ice containers for up to 30 days to maintain quality. Moderna’s vaccines must be shipped at -20 degrees Celsius, but the company says they can also be stored for 30 days at temperatures between 2 and 7 degrees Celsius, which is the temperature of a typical household refrigerator.
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