FDA allowing longer refrigerator storage for Pfizer-BioNTech vaccines
The Food and Drug Administration (FDA) ruled to allow longer storage of Pfizer-BioNTech coronavirus vaccines in typical refrigerator temperatures on Wednesday, in a decision expected to boost accessibility to doses.
The agency moved to extend the storage time for thawed shots to up to one month between 35 and 46 degrees Fahrenheit, instead of the previous regulation of up to five days.
The FDA permitted the increased storage time after Pfizer submitted data showing that its vaccine remained “stable” at refrigerator temperatures for up to a month.
“Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a release.
“This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine,” Marks added.
The European Medicines Agency also decided earlier this week that the Pfizer-BioNTech vaccine could be kept at refrigerator temperatures for up to a month after analyzing Pfizer’s new data.
One of the challenges of distributing the Pfizer-BioNTech vaccine has been the temperature requirements for transport and storage.
The drugmaker previously said the vaccine needed to be stored at temperatures between minus 112 and minus 76 degrees Fahrenheit, which required special and more expensive freezers.
Earlier this year, the FDA approved storing the doses at regular freezer temperature up to two weeks, making it easier to get the vaccine to places such as rural communities or lower-income countries.
More than 149 million doses of the Pfizer-BioNTech have been administered in the U.S., making up more than half of all doses given in the country, according to Centers for Disease Control and Prevention data.