The Food and Drug Administration will allow undiluted frozen vials of the Pfizer COVID-19 vaccine to be transported and stored at conventional pharmaceutical freezer temperatures (-13°F to 5°F) for up to two weeks as an alternative to its preferred storage at -112 F to -76ºF, the agency announced yesterday.
Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research, said the alternative “will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”
Pfizer submitted data demonstrating that the vaccine remains stable when undiluted frozen vials are stored up to two weeks at standard freezer temperature. The flexibility does not apply to thawed vials. For more information, see the updated FDA factsheet for providers administering the vaccine.
In other news, FDA today added new devices to its list of discontinued medical devices, including sterilization products and oxygen conservers. The Coronavirus Aid, Relief, and Economic Security requires manufacturers to notify FDA when a manufacturing discontinuance or interruption is likely to disrupt the U.S. supply of certain devices during a public health emergency.