The U.S. Medicines Agency (FDA) on Thursday cleared the Pfizer / BioNTech alliance’s COVID-19 vaccine to be stored at freezer temperatures, higher than hitherto permitted, which will facilitate its distribution.
The FDA “allows frozen and undiluted doses of Pfizer / BioNTech’s COVID-19 vaccine to be transported and stored at conventional temperatures commonly used for pharmaceutical freezers for a period of up to two weeks,” he said. -she said in a press release.
“This constitutes an alternative to the favored storage of undiluted doses at an ultra-low temperature” between -80oC and -60oC, she specified.
Pfizer and BioNTech announced Friday that they had made this request to US health authorities.
They said they had provided data demonstrating “the stability of the vaccine” when stored between -25 and -15 degrees Celsius, the temperature of common medical freezers.
According to the request of the two companies, this period was to be added to the possibility of keeping the product in a normal refrigerator (between +2 and +8 degrees) for five days.
This FDA clearance “is important and allows doses to be transported and stored under more flexible conditions,” Peter Marks, director of the Agency’s Center for Biological Research and Control, said in the statement.
“This alternate temperature will help alleviate the burden of providing ultra-cold storage equipment at vaccination sites, and should help deliver vaccines to more sites,” he added.
Another vaccine based on messenger RNA technology, Moderna’s vaccine can be stored for six months at -20 degrees and remain stable in the conventional refrigerator for 30 days.