Vaccine Developments: Pfizer seeks approval for storage at higher temperatures, J&J seeks WHO approval

Pfizer seeks U.S. approval for COVID-19 vaccine to be stored at higher temperatures Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing for it to be kept in pharmacy freezers, they said on Friday. Reuters Staff U.S.

FRANKFURT (Reuters) - Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing for it to be kept in pharmacy freezers, they said on Friday.

An approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that may potentially ease distribution of the shot in lower-income countries.

The companies have submitted new temperature data to the U.S. Food and Drug Administration to support an update to the current 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.

The current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

The shot’s cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.

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