Fri, 05 Mar 2021

FRANKFURT, Germany - U.S. health regulators are being asked to allow the Coronavirus vaccine to be stored at warmer temperatures than currently required.

The request comes from Pfizer Inc and BioNTech SE, who have petitioned the US Food and Drug Administration (FDA) to allow their COVID-19 vaccine to be stored at higher temperatures, including in pharmacy freezers.

Accompanying their requests, they submitted new data to the FDA to support allowing vials to be stored at -25 to -15 degrees Celsius (-13F to 5F) for up to two weeks.

Current requirements include storing vaccination vials at temperatures between -80C and -60C (-112F to -76F), resulting in the use of specially designed containers when shipping Covid vaccinations.

The higher temperatures would "greatly expand the ability to use this vaccine in many parts of the world (or even the U.S.) that do not have the capacity for deep freeze storage," according to Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, as quoted by Reuters.

Besides petitioning the American FDA, Pfizer and BioNTech SE intend to seek permission from global regulatory agencies to store vaccinations at higher temperatures, said company officials.

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

The World Health Organization has limited distribution of the Pfizer-BioNTech vaccines to only a few countries, partly due to concerns about the availability of cold storage in developing nations.

"We are aware of reports of this and look forward to seeing the data. If proven correct, this could make rollout of the vaccine easier in all countries, and particularly in low-income ones," WHO officials said in a statement.

Moderna's vaccine has already received permission to be stored at temperatures of -25 to -15 degrees Celsius.

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