FDA Allows More Flexible Storage, Transportation for Pfizer-BioNTech COVID-19 Vaccine

Undiluted, frozen vials of Pfizer and BioNTech’s COVID-19 vaccine can now be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for up to 2 weeks, according to updated FDA guidance.¹

Authorizations have required the vaccine vials to be stored in freezers at temperatures between -112 degrees and -76 degrees Fahrenheit, where they can be kept for up to 6 months. Before mixing with a saline solution, they could also be refrigerated for up to 5 days at standard refrigerator temperatures between 36- and 46-degrees Fahrenheit.²

The companies submitted new data to the FDA earlier in February, demonstrating the stability of their vaccine at storage temperatures of -13 degrees to 5 degrees Fahrenheit.² The approval of these changes may make the vaccine more widely available and easier to stock.

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement. “This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions.”¹

The alternative temperature is not applicable to the storage of thawed vials before dilution, which can be held in the refrigerator for up to 5 days, or to the storage of thawed vials after dilution, which can be held at refrigerator temperatures or room temperature for use within 6 hours. The changes will be reflected in updates to the Fact Sheet for Health Care Providers Administering Vaccine.¹

“The 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 vaccines to more sites,” Marks said in his statement.¹

REFERENCES

• Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine [news release]. FDA; February 25, 202 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer. Accessed February 26, 202
• Pfizer, BioNTech Data Demonstrate COVID-19 Vaccine Stability at Standard Freeze Temperature. Pharmacy Times; February 19, 2021. https://www.pharmacytimes.com/news/pfizer-biontech-data-demonstrate-covid-19-vaccine-stability-at-standard-freeze-temperature. Accessed February 26, 2021.