FDA Updates Storage, Transportation Guidance for Pfizer-BioNTech COVID-19 Vaccine

Officials with the FDA recently announced updates to required storage and transportation conditions for the Pfizer-BioNTech COVID-19 vaccine.

The agency is now allowing undiluted frozen vials of the Pfizer-BioNTech vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezer for up to 2 weeks. Previously, the preferred storage of undiluted vials were ultra-low temperature freezers between -80 degrees and -60 degrees Celsius, or -112 degrees and -75 degrees Fahrenheit.

The updated guidance is based on data submitted by Pfizer to demonstrate that the COVID-19 vaccine remains stable after storage of the undiluted vials in the standard freezer temperature. The alternative temperature for storage is not applicable to the storage of thawed vials before dilution, which can be held at refrigerator temperature or room temperature for use within 6 hours.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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 vaccine to more sites.”

The updates are reflected in the agency’s Facts Sheets for Health Care Providers Administering Vaccine (Vaccination Providers), which are available on the FDA website.

Reference

1. Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine. News release. FDA; February 25, 2021. Accessed March 1, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer