FDA grants longer refrigerator storage for Pfizer-BioNTech vaccines
The 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 decision came after Pfizer submitted data showing that its vaccine remained “stable” at refrigerator temperatures for the time period.
“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,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a release.
Follows: 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.
Why this matters: One of the challenges of distributing the Pfizer-BioNTech vaccine has been the temperature requirements for transport and storage. Before refrigerator temperatures were approved, the vaccine had to be kept at temperatures between minus 112 and minus 76 degrees Fahrenheit, requiring special freezers that weren’t available in rural communities and lower-income countries.