Pfizer seeks U.S. approval to ease handling of COVID-19 vaccine

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By Reuters Staff

(Reuters) - Pfizer Inc and BioNTech SE have submitted new temperature data to the U.S. health regulator which they said on Friday could allow their COVID-19 vaccine to be stored in pharmacy freezers rather than in ultra-cold storage facilities.

If approved, the less onerous storage requirements would provide a significant logistical relief for the roll-out of the vaccine, particularly in lower-income countries that do not have the necessary infrastructure.

Pfizer/BioNTech's vaccine, along with Moderna Inc's two-dose shot, won the U.S. emergency use authorization (EUA) and is being widely distributed as part of the country's mass vaccination efforts.

The new data has been submitted to the U.S. Food and Drug Administration to support a proposed update to the current EUA label that would allow vaccine vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks as an alternative for storage in an ultra-low temperature freezer.

"The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility," BioNTech Chief Executive Officer Ugur Sahin said.

Pfizer/BioNTech's current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), calling for it to be shipped in specially designed containers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted

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