FDA Extends Pfizer-BioNTech COVID-19 Vaccine Refrigeration Storage Time to 30 Days

On May 20, the U.S. Food and Drug Administration extended the time that Pfizer-BioNTech’s COVID-19 vaccine can be stored in the refrigerator.

The vaccine, which people get in two doses, still needs to be shipped frozen at ultra-cold temperatures in the companies’ special thermal shipping container. Doses can be kept frozen in these containers for up to 30 days as long as dry ice is used to maintain temperatures of around -70°C (-94°F). Once thawed, the vaccine doses can now be kept in a refrigerator for up to one month. Previously, the emergency use authorization issued by the FDA only allowed the vaccine to be stored, thawed, in a refrigerator for five days.

The longer refrigeration time was authorized by the FDA after the agency reviewed data provided by Pfizer-BioNTech showing the vaccine remained stable and viable under refrigerated conditions for up to one month.

More pharmacies, doctors’ offices and smaller health centers have access to refrigeration than they do the ultra-cold freezers required for longer term storage of the Pfizer-BioNTech vaccine, so the FDA’s decision will give those who are now administering vaccines more flexibility in managing their doses. The FDA also recently allowed children as young as 12 to get vaccinated, and the federal government is shipping vaccines directly to pediatricians’ and doctors’ offices to increase access to vaccinations for everyone who is eligible for the shot. The companies are also working on a version of their COVID-19 vaccine that does not need to be frozen at all but can be shipped and stored under refrigerated conditions.