FDA allows more flexible storage option for Pfizer vaccine
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掳F to 5掳F) for up to two weeks as an alternative to its preferred storage at -112 F to -76潞F, the agency .
Peter Marks, M.D., director of FDA鈥檚 Center for Biologics Evaluation and Research, said the alternative 鈥渨ill help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.鈥
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 for providers administering the vaccine.
In other news, FDA today added new devices to its , 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.