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Regulatory Focus™ > News Articles > 2021 > 2 > FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

Posted 25 February 2021 | By Michael Mezher 

FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

The US Food and Drug Administration (FDA) on Thursday updated the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine to allow the vaccine to be transported and stored at temperatures found in conventional pharmaceutical freezers for up to two weeks.
 
The announcement comes one week after Pfizer and BioNTech disclosed they had submitted data demonstrating their vaccine’s stability at higher temperatures based on manufacturing data from the past nine months. The companies said they would provide the data to other global regulators in the coming weeks.
 
The alternative transportation and storage conditions should alleviate one of the most challenging aspects of deploying the Pfizer-BioNTech vaccine. When it was first authorized, the undiluted vaccine was required to be shipped in specialized thermal containers and stored in ultra-low temperature freezers between -80C and -60C.
 
In an updated fact sheet for health care providers administering the vaccine, FDA explains that undiluted vials should be preferably be stored at those ultra-low temperatures until their printed expiry date but may alternatively be stored in at -25C to -15C for up to two weeks.
 
FDA notes that the alternative storage temperature does not apply to thawed vials before dilution, which can be stored in a refrigerator for up to five days, or to diluted thawed vials, which can be stored at fridge or room temperature for up to six hours.
 
“This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage with help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” said Center for Biologics Evaluation and Research Director Peter Marks.
 
FDA

 

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