FDA Drops Ultra-Cold Storage Rule for Pfizer Vaccine

Allowing regular freezer temperatures should simplify distribution
By Bob Cronin,  Newser Staff
Posted Feb 25, 2021 6:35 PM CST
Regular Freezer is Fine for Pfizer Vaccine: FDA
A readout shows the inside temperature on a freezer used to store Pfizer's COVID-19 vaccine at the company's manufacturing site in Portage, Mich., last week.   (AP Photo/Evan Vucci)

The Food and Drug Administration made distribution of the Pfizer coronavirus vaccine easier on Thursday by decreeing it can be stored in regular freezer temperatures after all. The agency had required the vaccine be kept at minus 76 degrees Fahrenheit to minus 112 degrees, the Hill reports. That was a major complication; many places, especially rural ones, don't have equipment that can do that. The FDA said the Pfizer product can safely be stored in "conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks." An official said the change should "ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites."

A study found last week that it was safe to keep the vaccine at normal freezer temperatures, and Pfizer requested the change. But the FDA didn't agree until Thursday. The vaccine usually is packed with dry ice in thermal containers when it reaches vaccination sites, per the Washington Post. In new guidance for health care providers, the FDA said it still prefers the vaccine be kept in ultra-cold storage but will permit storage in standard pharmaceutical freezers. The change does not apply to vials of vaccine that have thawed. The Moderna vaccine has never had to be stored at ultra-low temperatures, but freezer issues have still had an impact. A hospital in northern California had to use up 830 doses quickly when a freezer failed, and 1,900 doses were lost when a freezer in Boston was unplugged during cleaning. (More Pfizer stories.)

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