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Pfizer Seeks FDA Approval For Higher Coronavirus Vaccine Storage Temperatures

Pfizer and its German partner, BioNTech, have submitted data to the FDA that shows its coronavirus vaccine can be stored at "temperatures more commonly found in pharmaceutical freezers and refrigerators."

Pfizer Inc.  (PFE) - Get Pfizer Inc. Report said Friday that its coronavirus vaccine could be stored at higher temperatures, making it easier to transport and distribute, and asked the U.S. Food & Drug Administration to change the terms of its emergency approval.  

Pfizer and its German partner, BioNTech  (BNTX) - Get BioNTech SE Report, submitted new data to the FDA that it hopes will change its Emergency Use Authorization (EUA) approval order from December and allow for the BNT162b2 vaccine to be stored at between -25 and -15 degrees Celsius for up to two weeks,  "temperatures more commonly found in pharmaceutical freezers and refrigerators." 

The Pfizer vaccine, which uses messenger RNA technology, must currently be stored in ultra-cold freezers at temperatures of between -80 and -60 degrees Celsius, and then thawed for three hours in a refrigerator and then diluted within the next two hours.

"We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,' said CEO Albert Bourla. 'We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions."

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"If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply," he added.

Pfizer shares were marked 0.23% lower in early trading Friday to change hands at $34.50 each.  

Earlier this month, Pfizer boosted its 2021 profit forecast thanks in part to expected sales of around $15 billion for its recently approved coronavirus vaccine. Pfizer said its sees adjusted earnings in the region of $3.10 to $3.20 per share -- a 10 cent improvement from its prior forecast -- on total revenues of between $59.4 billion and $61.4 billion.

The drugmaker vowed in January to boost the manufacturing pace of its coronavirus vaccine with the aim of delivering 2 billion doses by the end of the year.