The FDA “authorizes the frozen and undiluted doses of the Pfizer / BioNTech vaccine against COVID-19 to be transported and stored at conventional temperatures commonly used for pharmaceutical freezers for up to two weeks,” the agency said in a statement. a statement.
“This is an alternative to favored storage of undiluted doses at an ultra-low temperature,” between -80 and -60 degrees Celsius, the FDA said.
Pfizer and BioNTech announced last Friday that they had made this request to the US health authorities, stating that they provided data demonstrating the “stability of the vaccine” when stored at temperatures between -25 and -15 degrees Celsius, ie the temperature of regular medical freezers.
According to the request, this duration was to be added to the possibility of keeping the product in a normal refrigerator (at temperatures between +2 and +8 degrees Celsius) for five days.
Authorization by the FDA “is important and allows doses to be transported and stored in more flexible conditions,” Peter Marks, director of the FDA’s Center for Biological Control and Research, was quoted as saying.
“This alternative temperature will help reduce the challenge of purchasing ultra-cold storage equipment at vaccination centers, and should help transport vaccines to more centers,” he added.
The other vaccine based on messenger RNA technology and authorized by the FDA, the vaccine developed by Moderna, can be stored for 6 months at -20 degrees and remains stable in a classic refrigerator for 30 days.
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