Update: According to information published by Wired, the smallpox vials were among a consignment of 327 vials, some of which contained infectious diseases. The full statement from the FDA is as follows:
The investigation found 12 boxes containing a total of 327 carefully packaged vials labeled with names of various biological agents such as dengue, influenza, Q fever, and rickettsia. Upon the discovery of these vials on July 1, 2014, 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.
As announced on July 8, 2014, six vials labeled “variola” (the causative agent of smallpox) along with ten other samples with unclear labeling were transported safely and securely with the assistance of federal and local law enforcement agencies in a government aircraft to CDC’s high-containment facility in Atlanta. In addition, 32 samples were destroyed following inventory at the NIH facility, including 28 labeled as normal tissue and four labeled as “vaccinia,” the virus used to make the smallpox vaccine. To be clear, vaccinia does not cause smallpox. These vials represented no value to forensic sciences and were destroyed according to standard protocols.
The remaining 279 biological samples were then transferred by the investigating agencies to the U.S. Department of Homeland Security’s National Bioforensic Analysis Center for safeguarding. There were no smallpox samples included in this transfer. The FDA received confirmatory information about the samples yesterday, thus permitting public disclosure of this additional information.
Further announcements from the NIH go on to clarify that there was no evidence that anyone was exposed to these agents. The collection was probably assembled between 1946 and 1964, when standards of collection and storage were very different from today.
“We have developed a plan of action for the conduct of this search,” says Doctor Francis Collins of the NIH, outlining a plan of action after the discovery. “It requires investigators to examine all freezers, refrigerators, cold rooms, storage shelves, and cabinets, as well as all other areas of storage such as offices associated with laboratories, to be sure that there are no further examples of potentially harmful materials that are being improperly stored.”
“The vials appear to date from the 1950s,” says the CDC. “Upon discovery, the vials were immediately secured in a CDC-registered select agent containment laboratory in Bethesda.”
During a routine clear-out of a FDA storage area at a National Institute of Health research lab at Bethesda, Maryland, “employees discovered vials labelled ‘variola,’ commonly known as smallpox, in an unused portion of a storage room,” says the Center for Disease Control. It is not yet known whether the smallpox, kept in six glass vials in a cardboard box, is viable. Tests are being carried out, and will take two weeks to complete, after which the samples will be destroyed.
Smallpox, declared eradicated in 1979, is one of the most virulent infectious diseases mankind has ever dealt with. It’s estimated to have been responsible for 300-500 million deaths during the 20th Century alone; it kills one in three infected. There are supposed to be only two high security labs keeping a stock of the disease, one in Russia’s Novosibirsk State Research Centre of Virology and Biotechnology, the other at CDC Atlanta.
The FBI is trying to find out how the samples were prepared and eventually stored at the Food and Drug Administration lab. The vials seem to date from the 1950s, and the lab was transferred from the NIH to the FDA in 1972. However the building itself wasn’t built until the 1960s, which begs the question where the samples were before they went to the lab.
Both labs authorized to hold smallpox take extreme precautions with their stock; the last known case, in Britain in 1978, occurred when a lab accident infected a university photographer who subsequently died. The photographer wasn’t even in the same room as the disease, but in a lab above, and was infected via the ventilation system. Scientists who work with smallpox wear full body suits, including gloves and goggles, and shower with strong disinfectant before leaving the lab. It’s been suggested that the current stock should be destroyed, but so far the prevailing view has been that it might yet be needed to research better treatments and vaccines.
While it was once routine to have a smallpox vaccination, the treatment proved to have serious side effects in a small percentage of the population. As a consequence, in the US the vaccination program was abandoned in 1972, since at that point the potential consequences of vaccination were more worrying than the disease. There was a period from 2002 to 2004 when military and some civilian health care workers received vaccination due to the potential threat of a bioterrorist attack, but apart from that small pool the majority in the US have no immunity.
According to Dr. William Schaffner, infectious disease specialist working at Vanderbilt University “every single research lab in the world was asked to scour their facilities and submit all specimens for accounting and destruction.” Dr Schaffner finds it “seems curious beyond belief” that these vials escaped destruction.
The full CDC statement concerning the discovery can be found here.