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On July 1, 2014, the National Institutes of Health (NIH) notified the appropriate regulatory agency, the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC), that employees discovered vials labeled ”variola,” commonly known as smallpox, in an unused portion of a storage room in a Food and Drug Administration (FDA) laboratory located on the NIH Bethesda campus.
The laboratory was among those transferred from NIH to FDA in 1972, along with the responsibility for regulating biologic products. The FDA has operated laboratories located on the NIH campus since that time. Scientists discovered the vials while preparing for the laboratory’s move to the FDA’s main campus.
The vials appear to date from the 1950s. Upon discovery, the vials were immediately secured in a CDC-registered select agent containment laboratory in Bethesda.
There is no evidence that any of the vials labeled variola has been breached, and onsite biosafety personnel have not identified any infectious exposure risk to lab workers or the public.
Late on July 7, the vials were transported safely and securely with the assistance of federal and local law enforcement agencies to CDC’s high-containment facility in Atlanta. Overnight PCR testing done by CDC in the BSL-4 lab confirmed the presence of variola virus DNA. Additional testing of the variola samples is under way to determine if the material in the vials is viable (i.e., can grow in tissue culture). This testing could take up to two weeks. After completion of this testing, the samples will be destroyed.
By international agreement, there are two official World Health Organization (WHO)-designated repositories for smallpox: CDC in Atlanta, Georgia and the State Research Centre of Virology and Biotechnology (VECTOR) in Novosibirsk, Russia. The WHO oversees the inspection of these smallpox facilities and conducts periodic reviews to certify the repositories for safety and security.
CDC has notified WHO about the discovery, and WHO has been invited to participate in the investigation. If viable smallpox is present, WHO will be invited to witness the destruction of these smallpox materials, as has been the precedent for other cases where smallpox samples have been found outside of the two official repositories.
DSAT, in collaboration with the Federal Bureau of Investigation, is actively investigating the history of how these samples were originally prepared and subsequently stored in the FDA laboratory.