- For immediate release:
Today, the US Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for up to two weeks. This reflects an alternative to preferential storage of undiluted bottles in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is reflected in updates to the information leaflet for healthcare professionals who administer vaccines (vaccination providers).
“Pfizer sent data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transporting and storing undiluted bottles is significant and allows the bottles to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of purchasing ultra-low storage equipment for vaccination sites and should help move the vaccine to more locations, ”said Peter Marks, MD, Ph.D., director of the Center for FDA for Biological Research and Evaluation.
Pfizer Inc. has submitted data to the FDA to demonstrate that its COVID-19 vaccine remains stable after storing undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storing frozen bottles is not applicable for storing thawed bottles before dilution (which can be kept in the refrigerator for up to 5 days), or for storing thawed bottles after dilution (which can be kept in the refrigerator temperature room temperature for use within 6 hours).
The updated Technical Sheets for Health Service Providers that Administer Vaccines (Vaccine Providers) are intended to help frontline employees understand new transportation alternatives and storage temperatures. Technical data sheets are available on the FDA website.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security and protection of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.
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