FDA allows Pfizer-BioNTech COVID-19 vaccine to be stored at higher temperatures

Coronavirus Vaccine

Medical staff receive part of a Pfizer-BioNTech Covid-19 vaccine shipment at the UZ Leuven hospital in Leuven, Belgium, Saturday, Dec. 26, 2020. Belgium is preparing to begin its Covid-19 vaccination program, with first vaccinations beginning on Monday. (Nicolas Maeterlinck, Pool via AP)

WASHINGTON (NewsNation Now) — The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.

Last week, the companies had asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers.

“Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.

The FDA said that Pfizer submitted data showing the vaccine remains stable for two weeks at normal refrigeration temperatures. They added this does not apply though to thawed vaccines which do need to be stored at the ultra-cold temperatures.

In December, the FDA granted emergency use authorization to the vaccine and current label to be stored at temperatures between -112ºF to -76ºF, meaning it has to be shipped in specially designed containers.

Reuters contributed to this report.

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