Forgotten vials of smallpox found in NIH storage room - FOX 35 News Orlando

Forgotten vials of smallpox found in NIH storage room

Posted: Updated:

By MIKE STOBBE
AP Medical Writer

ATLANTA (AP) — A government scientist cleaning out an old storage room at a research center near Washington made a startling discovery last week — decades-old vials of smallpox packed away and forgotten in a cardboard box.

The six glass vials were intact and sealed, and scientists have yet to establish whether the virus is dead or alive, the Centers for Disease Control and Prevention said Tuesday.

Still, the find was disturbing because for decades after smallpox was declared eradicated in 1980, world health authorities said the only known samples left were safely stored in super-secure laboratories in Atlanta and in Russia.

Officials said this is the first time in the U.S. that unaccounted-for smallpox has been discovered. At least one leading scientist raised the possibility that there are more such vials out there around the world.

The CDC and the FBI are investigating.

It was the second recent incident in which a U.S. government health agency appeared to have mishandled a highly dangerous germ. Last month, scores of CDC employees in Atlanta were feared exposed to anthrax because of a laboratory safety lapse. The CDC began giving them antibiotics as a precaution.

The freeze-dried smallpox samples were found in a building at the National Institutes of Health in Bethesda, Maryland, that has been used by the Food and Drug Administration since 1972, according to the CDC.

The scientist was cleaning out a cold room between two laboratories on July 1 when he made the discovery, FDA officials said.

Officials said labeling indicated the smallpox had been put in the vials in the 1950s. But they said it's not clear how long the vials had been in the building, which did not open until the 1960s.

No one has been infected, and no smallpox contamination was found in the building.

Smallpox can be deadly even after it is freeze-dried, but the virus usually has to be kept cold to remain alive and dangerous.

In an interview Tuesday, a CDC official said he believed the vials were stored for many years at room temperature, which would suggest the samples are dead. But FDA officials said later in the day that the smallpox was in cold storage for decades.

"We don't yet know if it's live and infectious," said Stephan Monroe, deputy director of the CDC center that handles highly dangerous infectious agents.

The samples were rushed under FBI protection to the CDC in Atlanta for testing, which could take a few weeks. After that, they will be destroyed.

Peter Marks, deputy director of the FDA's Center for Biologics Research and Evaluation, said the discovery was unexpected but not a total shock. He added, however, that "no one's denying we should have done a better job cleaning out what was there."

In at least one other such episode, vials of smallpox were found at the bottom of a freezer in an Eastern European country in the 1990s, according to Dr. David Heymann, a former World Health Organization official who is now a professor at the London School of Hygiene and Tropical Medicine.

Heymann said that when smallpox samples were gathered up for destruction decades ago, requests went out to ministers of health to collect all vials.

"As far as I know, there was never a confirmation they had checked in with all groups who could have had the virus," he said.

Dr. Donald "D.A." Henderson, who led the WHO smallpox-eradication effort and is now a professor at the Center for Health Security at the University of Pittsburgh, said it is highly unlikely more such stashes will be discovered. But he conceded "things were pretty casual" in the 1950s.

Decades ago, he recalled, "I came back from many a trip carrying specimens, and I just put them in the refrigerator until I could get them to a laboratory. My wife didn't appreciate that."

Smallpox was one of the most lethal diseases in history. For centuries, it killed about one-third of the people it infected, and left most survivors with deep scars on their faces from the pus-filled lesions.

The last known case was in Britain in 1978, when a university photographer who worked above a lab handling smallpox died after being accidentally exposed to it through the ventilation system.

Global vaccination campaigns finally brought smallpox under control. After it was declared eradicated, all known remaining samples of live virus were stored at a CDC lab in Atlanta and at a Russian lab in Novosibirsk, Siberia.

The labs take extreme precautions. Scientists must undergo fingerprint or retinal scans to get inside, they wear full-body suits including gloves and goggles, and they shower with strong disinfectant before leaving the labs.

There has long been debate over whether to destroy the stockpile.

Many scientists argue that any remaining samples pose a threat and that the deadly virus should be wiped off the planet altogether. Others contend the samples are needed for research on better treatments and vaccines.

At its recent annual meeting in May, WHO put off a decision again.

___

AP Medical Writers Maria Cheng in London and Marilynn Marchione in Milwaukee contributed to this report.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


UPDATE: The CDC released the following statement on the discovery:

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.


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