An FDA scientist’s stunning discovery of decades-old vials of smallpox virus at an agency lab will not delay the facility’s move to FDA’s main White Oak campus this summer.

On July 1, the scientist found boxes containing the vials in a cold storage area during an inventory of the lab, which is located at the National Institutes of Health in Bethesda. The inventory was being conducted in preparing to move the lab to the agency’s campus in Silver Spring. The Centers for Disease Control and Prevention told media outlets on July 11 that two of the vials contained live virus.

FDA said the boxes appeared to have been undisturbed for many years. Since the discovery the agency has completed an inventory of all common storage areas in its NIH campus buildings and found no other materials of public health concern.

“We are carefully examining our policies and procedures regarding the security of our laboratories and storage of biologic specimens,” the agency stated in an email response to questions about the discovery. “We will ensure the implementation of a corrective action plan to ensure that our biological specimens are inventoried and properly secured.”

The agency noted that it does not have smallpox or any other agents of similar biosafety risk on its White Oak campus.

CDC Halts Transfer Of Biological Materials From Certain Facilities

Members of the Senate Health, Education, Labor, and Pensions Committee sent a July 11 letter to HHS Secretary Sylvia Burwell seeking more information about the smallpox discovery. They asked what actions are being taken in response to the finding and whether there are plans for a broader inventory of HHS laboratories. They also noted that “other unlabeled and ambiguously labeled vials” were found with those labeled as variola and asked if the contents of these vials have been tested and identified.

The 20 Senators who signed the letter also cited two other incidents in which pathogens were reportedly mishandled. In June, bioterrorism researchers at CDC discovered that they had mistakenly sent live anthrax specimens, which they thought were deactivated, to two labs with lower biosafety levels (BSLs). And in May, a CDC lab unintentionally transferred an influenza sample to a laboratory at the US Department of Agriculture that was contaminated with H5N1, a highly virulent strain of avian influenza.

On July 11, CDC announced that as a result of these two incidents it is issuing a moratorium on the movement of biological materials from BSL3 or BSL4 facilities pending review by an advisory committee.

The agency also issued a report on the anthrax incident, which concluded that scientists failed to follow a written study plan that met all laboratory safety requirements. The agency also found that there was a lack of standard operating procedures to document when biological agents are properly inactivated in laboratories and a lack of adequate laboratory oversight of scientists working in the labs. CDC said that it has established a high-level working group to accelerate improvements in laboratory safety and begun to establish an external advisory group for laboratory safety.

Move To White Oak Continues Through The Summer

NIH regulated vaccines, including smallpox vaccine, until July 1972, when the regulatory authority was transferred to FDA. At that time, the laboratories on the NIH campus were transferred to FDA. FDA said it uses the two labs that share the cold storage room to conduct regulatory research related to the production and regulation of biologics. One of the labs does research on biological proteins and the other does research on vaccines, such as influenza vaccine.

“We will ensure the implementation of a corrective action plan to ensure that our biological specimens are inventoried and properly secured,” FDA said.

“Although an investigation is ongoing, it is likely that an investigator involved in smallpox research prior to the time that smallpox was eliminated, may have left the boxes in a cold storage area,” FDA said. “These were then only discovered as part of the inventory undertaken in preparation for the move of the FDA laboratories from the NIH campus in Bethesda to the consolidated FDA campus in Silver Spring.”

The agency said the transfer of the labs is going ahead as planned. The first laboratories recently moved and the rest of the transition will continue throughout the summer. FDA built a new quad of buildings at its White Oak campus to house the agency’s Life Sciences-Biodefense Laboratory complex.

Construction had been under way since the end of FY 2010. This year, several thousand FDA employees will be moving there Also see "FDA Winding Down White Oak Construction; Outside Rents Going Up" - Pink Sheet, 10 March, 2014..

CDC issued a media statement on July 8, explaining that vials labeled “variola,” commonly known as smallpox, were discovered in an unused portion of a storage room in the FDA lab. CDC said the vials appear to date from the 1950s.

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

The vials were transported to CDC’s high-containment facility in Atlanta and testing is being done to determine if the material in the vials can grow in tissue culture. CDC said testing could take up to two weeks after which the samples will be destroyed. But on Friday, the agency said that two of the vials had viable virus.

CDC’s Division of Select Agents and Toxins is working with the FBI in investigating the history of how the samples were originally prepared and stored in the FDA lab.

Smallpox Stocks Needed For Antiviral Research, WHO Committee Says

Smallpox is an acute contagious disease caused by the variola virus. It is transmitted person to person through infected aerosols and droplets from infected symptomatic people. According to the World Health Organization, smallpox was declared eradicated in 1980 following a global WHO-led immunization campaign. Stocks of the virus are kept at two high-containment laboratories, one at the CDC and the other in Russia.

WHO’s Advisory Committee on Variola Virus Research discussed whether live variola virus was needed for further research at its meeting in September 2013. The majority of committee members concluded that there was no need to retain the virus for development of further diagnostics for smallpox or for the development of safer vaccines beyond the studies that have already been approved. But the majority felt the virus was needed for further development of antiviral agents against smallpox.

An advisory group of independent experts reviewing the smallpox research programme (AGIES) submitted a report to WHO in November in which they concluded that there was no need to retain live variola virus for development of diagnostics, vaccines or antiviral agents.

The World Health Assembly took up the issue at its meeting in May and delegates concluded that further analysis was needed before they could decide whether all stockpiles of the smallpox virus should be eradicated.

At the WHO advisory committee meeting, a representative of Chimerix Inc. gave an update on the development of its candidate antiviral bincidovofir and someone from Siga Technologies Inc. gave an update on its candidate tecovirimat.

FDA has also evaluated the two antivirals, questioning whether sponsors could use substitute pathogens in studying the treatments in animals Also see "Smallpox Treatments: Are Monkeypox Or Mousepox Acceptable Substitutes For Studying The Virus?" - Pink Sheet, 13 December, 2011..

Siga, which specializes in development of pharmaceutical agents to fight pathogens capable of use as bioweapons, plans to provide tecovirimat (ST-246) to the government’s Strategic National Stockpile.

Chimerix is also developing bincidovofir (CMX001) for treatment of immunosuppressed patients vulnerable to cytomegalovirus infection. The compound is a prodrug of Gilead Sciences Inc./Pfizer Inc.’s Vistide (cidofovir), an intravenous antiviral that is approved for the treatment of CMV retinitis in patients with AIDS ([A#14140325006]).

The WHO committee also heard updates on smallpox vaccine research. One of the vaccines, Bavarian Nordic AS’ Imvanex (Imvamune in the U.S.), was licensed in the European Union in August 2013. The company is positioning it as a next-generation smallpox vaccine for people who are immunocompromised and/or with medical conditions that make it difficult to take the older vaccines currently approved and stockpiled Also see "Uncle Sam's Orders: Emergent Scores $107 Mil. For Anthrax Plant, While Bavarian Nordic Delivers On Smallpox" - Pink Sheet, 16 July, 2010..

The U.S. government funded development of the vaccine under its Project BioShield program. The Danish company has supplied millions of doses to the U.S. Strategic National Stockpile and to other governments around the world Also see "Europe Backs Celgene’s Pomalidomide And Aegerion’s Lomitapide" - Pink Sheet, 31 May, 2013..

Smallpox Discovery Prompts FDA Action Plan; Move To White Oak Unchanged

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