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CDC Media Statement on Newly Discovered Smallpox Specimens

For Immediate Release: Tuesday, July 8, 2014

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 2 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.

Smallpox vials from 1950s found in U.S. lab storage room

By Julie Steenhuysen and David Beasley

CHICAGO/ATLANTA Tue Jul 8, 2014 7:21pm EDT

(Reuters) – Stray vials of the deadly smallpox virus from the 1950s have been discovered at a federal lab near Washington, U.S. health officials said on Tuesday, the second lapse discovered in a month involving a deadly pathogen at a government facility.

The U.S. Centers for Disease Control and Prevention said that workers discovered the vials in a cardboard box on July 1 while clearing out an old lab on the National Institutes of Health campus in Bethesda, Maryland.

The six glass vials contained freeze-dried smallpox virus and were sealed with melted glass. The vials appeared intact and there is no evidence that lab workers or the general public are at risk, said CDC spokesman Tom Skinner.

The mishandling of smallpox follows the CDC’s recent mishap in which the agency believed it may have transferred live anthrax samples to a CDC lab that was not equipped to handle them, potentially exposing dozens of employees to the pathogen.

The CDC is testing the vials to see if the smallpox is viable and could make someone sick, said Skinner. After those tests, which could take up to two weeks, the samples will be destroyed, Skinner said.

Smallpox was eradicated worldwide in 1977, but samples of the pathogen are kept in two repositories for research purposes: the CDC’s facility in Atlanta and the State Research Center of Virology and Biotechnology in Novosibirsk, Russia. The two repositories are monitored by the World Health Organization.

The CDC said it has notified WHO about the discovery. If the specimens turn out to be viable, the CDC said it will invite the WHO to witness the destruction of the smallpox samples.

Skinner said the CDC is working with the Federal Bureau of Investigation to determine how and when the samples were prepared and how they came to be stored and forgotten in the FDA lab.

Infectious disease expert Dr. Michael Osterholm said the discovery of abandoned vials of smallpox is a reminder to labs globally to take stock of what is in their freezers.

Although there have been concerns smallpox could be used in bioterrorism, the CDC says the chances of that occurring are very low. Currently, the government has a stockpile containing enough vaccine for every U.S. citizen.

The bigger threat, Osterholm said, is that these vials could have fallen into the hands of someone who would convert them into an aerosolized form and use them as a bioterror weapon.

“That could be a disaster,” he said.

(Additional reporting by David Beasley in Atlanta; Reporting by Julie Steenhuysen; Editing by Chizu Nomiyama, Richard Chang and Lisa Shumaker)

‘Forgotten’ US smallpox vials found in cardboard box

8 July 2014 Last updated at 19:20 GMT

Long forgotten vials of smallpox left in a cardboard box have been discovered by a government scientist at a research centre near Washington, officials say.

The virus, believed dead, was located in six freeze-dried and sealed vials, according to the Centers for Disease Control and Prevention (CDC).

It is said to be the first time unaccounted-for smallpox has been discovered in the US.

The disease was officially declared eradicated in the 1980s.

“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, [Maryland],” according to a CDC statement.

“There is no evidence that any of the vials labelled variola has been breached, and onsite biosafety personnel have not identified any infectious exposure risk to lab workers or the public,” the statement added.

Government agencies were notified of the discovery on 1 July, after National Institutes of Health (NIH) employees discovered the vials labelled “variola”, also known as smallpox.

The vials were located in an unused area of a storage room in a Food and Drug Administration laboratory on an NIH campus in Bethesda.

The vials were subsequently transported to a secure facility in Atlanta, Georgia, on 7 July.

Tests will be conducted on the material to determine if it is viable before it destroyed, the CDC said.

The virus may remain deadly even after freeze-drying, though is it typically kept cold to remain alive.

The CDC also notified the World Health Organization (WHO) of the discovery. The WHO currently oversees two designated repositories for smallpox; one in Atlanta as well as one in Novosibirsk, Russia.

It is the not the first time vials of smallpox have been unexpectedly discovered. Several were found at the bottom of a freezer in Eastern Europe in the 1990s, according to media reports.