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February 10, 2016

FDA Lab With Smallpox Vials Had Other Dangerous Biological Agents

The Food and Drug Administration lab on the NIH campus where six vials of smallpox were discovered also had biological agents causing such diseases including dengue, influenza, Q fever, and rickettsia, government officials have disclosed.

“Overlooking such a sample collection is clearly unacceptable,” FDA said in a statement Wednesday. “The FDA has already taken steps to ensure that similar material is not present in its other cold storage areas by initiating a thorough review of all common cold storage spaces.”

A bipartisan letter from the Senate Health, Education, Labor and Pensions Committee last week asked HHS officials about what other items were found along with the six vials of smallpox. It also asked what measures the department was taking in all of its labs to ensure proper handling of dangerous biological agents. FDA’s statement said that “all of the items labeled as infectious agents found in the collection of samples were stored in glass, heat-sealed vials that were well-packed, intact, and free of any leakage, and there is no evidence that anyone was exposed to these agents.”

The various agents at the lab were discovered July 1. FDA said investigators found “12 boxes containing a total of 327 carefully packaged vials.” FDA employees “followed standard protocol and turned them all over to the appropriate NIH safety program officials, who in turn transferred them to the appropriate investigative agencies, as per standard protocols.” The smallpox samples were believed to date back to 1954.

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