For immediate release:

Today, the United States Food and Drug Administration announced it is allowing undiluted frozen vials of Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of time. up to two weeks. This reflects an alternative to the preferred storage of undiluted vials in an ultra-low temperature freezer between -80 ° C and -60 ° C (-112 ° F to -76 ° F). The change is reflected in the updates to the Information Sheet for Health Care Providers Administering Vaccines (Vaccine Providers).

“Pfizer has submitted data to the FDA to support this alternative temperature for transport and storage. This alternate temperature for transport and storage of undiluted vials is significant and allows vials to be transported and stored under more flexible conditions. The alternate temperature for transport and storage will help ease the burden of purchasing ultra-low cold storage equipment for vaccination sites and should help get the vaccine to more sites, ”said Peter Marks , MD, Ph.D., director of the FDA Center for Biologics Evaluation and Research.

Pfizer Inc. has submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storing undiluted vials for up to two weeks at standard freezer temperature. The alternate temperature for storing frozen vials is not applicable for storing thawed vials before dilution (which can be stored in the refrigerator for up to 5 days), or for storing thawed vials after dilution (which can be refrigerated temperature or room temperature for use within 6 hours).

The updated information sheets for healthcare providers who administer vaccines (vaccine providers) are intended to help front-line workers understand the new transport and storage temperatures. The fact sheets are available on the FDA website.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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