FDA Summary: FDA Approves Extension of Refrigerator Storage Period for Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Thawing, Making the Vaccine More Widely Available
The following quote is from Peter Marks, MD, Ph.D., director of the FDA's Center for Biologics Evaluation and Research.
Making the COVID-19 vaccine widely available is key to getting people vaccinated and ending the pandemic, Pfizer Inc. has submitted data to the FDA to support storage of undiluted, thawed vials of COVID-19 vaccine at refrigerator temperatures for up to one month. The data has been submitted to the FDA. This change should make the vaccine more widely available to the American public, as it will allow vaccine providers, such as local physician practices, to receive, store, and administer the vaccine.
Commentary
Based on the report submitted by Pfizer, the FDA has approved the storage of undiluted, thawed Pfizer-BioNTechCOVID-19 vaccine vials in refrigerators at 2-8°C (35°). This represents up to one month of storage; previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days.
The report briefly describes the data to show that undiluted, thawed vials are stable at refrigerator temperatures for up to one month, and a recently updated fact sheet for health care providers (immunization providers) who administer vaccines This fact sheet is now available on the FDA website and should be viewed by anyone who is interested.
