The FDA has issued an update regarding the discovery of vials containing the smallpox virus in a FDA storage room on July 1, 2014. The report includes information on additional vials with biological samples that were discovered in the laboratory in question.
In addition to the smallpox vials, 12 boxes containing a total of 327 vials labeled with biological agents that included dengue, influenza, Q fever, and rickettsia were also discovered on July 1, 2014. All vials were turned over to the National Institutes of Health (NIH) and transferred to the proper investigative agencies per standard protocol.
Six vials labeled “variola” (the virus that causes smallpox) and 10 additional samples with unclear labeling were transferred to the Centers for Disease Control and Prevention’s (CDC) high-containment facility in Atlanta. In addition, 32 samples (28 labeled as normal tissue and four labeled as “vaccinia” the virus used to make the smallpox vaccine) were destroyed according to standard protocols. The remaining 279 samples that did not include smallpox samples are under safeguard by the U.S. Department of Homeland Security’s National Bioforensic Analysis Center.
It is believed that the samples were collected from 1946–1964, when work and storage protocols for biological specimens differed from those in place today. All vials labeled as infectious agents were stored in glass vials that were heat-sealed, intact, well-packed, and free of any leakage.
The FDA asserts that there is no evidence that any employees were exposed to these agents and that efforts are underway to review all common storage spaces to ensure that similar material is not present in other cold storage areas. It is also reviewing its policies and procedures to avoid these events in the future.
For more information call (888) 463-6332 or visit FDA.gov.