Rinderpest Declared Eradicated

On June 28, 2011, the United Nations Food and Agriculture Organization (FAO) declared that rinderpest—a highly contagious viral disease that affects cloven-hoofed animals, causes high rates of animal mortality, and devastates communities dependent on livestock—has been eradicated. ¹ The announcement followed verification in May by the World Organization for Animal Health (OIE) that territories with rinderpest-susceptible animals were free of the disease. ²

The Global Rinderpest Eradication Program was launched in 1994, although work to control the disease had gone on for centuries. Two major tools that aided in eradication were a heat-stable vaccine developed in the 1980s and a rapid diagnostic test to distinguish rinderpest from other diseases with similar symptoms. Disease surveillance was used to confirm that rinderpest was no longer infecting animals and as a safeguard to ensure that the disease would be recognized if it were to occur. ²

Rinderpest is the first animal disease, and only the second disease in history, to be declared eradicated.

Tara Kirk Sell

World Health Assembly Votes to Retain Variola Virus for 3 More Years

On May 24, 2011, the World Health Assembly (WHA)—the decision-making body of the World Health Organization (WHO)—held a vote to determine whether to retain or destroy the world's remaining stocks of the Variola virus. Variola, which is the causative agent of smallpox, was declared eradicated from nature in 1980. Following WHO's certification of eradication, laboratory-maintained collections of the virus were consolidated. Now, only the United States Centers for Disease Control and Prevention (CDC) and the Russian State Research Institute for Viral Preparations are known to possess stores of live Variola virus. Both countries have maintained the virus in high-containment, BSL-4 laboratories, to enable ongoing research.

Discussions regarding the fate of the last remaining Variola virus stocks began in 1986, when the issue was first raised at the WHA. During the WHA's recent deliberations, the U.S., Russia, and a group of more than 2 dozen other nations were strongly in favor of retaining the virus to allow for the completion of scientific research toward development of vaccines, medicines, and diagnostic technologies. ¹

In a New York Times op-ed dated April 25, 2011, U.S. Secretary of Health and Human Services (HHS) Kathleen Sebelius suggested that “undisclosed or forgotten stocks” of the Variola virus could still exist elsewhere in the world, and that rapid progress in the field of synthetic genomics could theoretically enable a malicious actor to create Variola virus de novo. ² She went on to say:

After what was described as a “contentious” debate between the U.S.-led coalition in favor of virus retention and a group of developing nations in favor of virus destruction, the position championed by the U.S. and Russia proved persuasive. The WHA voted to retain the virus for a period of 3 years. ³ In its summary of the annual WHA meeting, WHO noted:

The Health Assembly strongly reaffirmed the decision of previous Assemblies that the remaining stock of smallpox (Variola) virus should be destroyed when crucial research based on the virus has been completed. The state of Variola virus research will be reviewed at the 67th World Health Assembly in 2014 and in light of that, determining a date for destruction of the remaining virus stocks will be discussed. ⁴

Matthew Watson

Panel Recommends Changes to the Select Agent Program

On June 13, 2011, the Federal Experts Security Advisory Panel (FESAP), co-chaired by Dr. George Korch of the Department of Health and Human Services (HHS) and Dr. Gregory Parham of the U.S. Department of Agriculture (USDA), released a report that recommended changes to the U.S. Select Agent Program. ¹

FESAP was created in July 2010 by Executive Order 13546 to advise the federal government on biological select agents and toxins (BSAT) regulations. The order asked the FESAP to consider the following:

1. the designation of Tier 1 BSAT;

The panel's recommendations for Tier 1 select agent status were made on the basis of an agent's ability to produce a mass casualty event, its communicability, and its history of use as a biological weapon, among other criteria. Major criteria for recommending the removal of a pathogen from the select agent list included a low potential for causing mortality and difficulty in producing quantities necessary for a high consequence event. ¹ Of the 82 agents currently listed as select agents, the panel recommends that 11 be given Tier 1 status and 25 be removed from the list. ² In the area of personnel reliability, FESAP recommended that the Criminal Justice Information Services Division—Bioterrorism Risk Assessment Group, which performs background checks on researchers requesting clearance to work on BSAT organisms, have access to the mental health component of the National Instant Criminal Background Check System (NICS). The panel also recommended that behavioral assessments be used to identify qualities that would preclude clearance for researchers working in facilities housing Tier 1 select agents.

Additionally, FESAP recommended that all foreign nationals requesting access to biological select agents and toxins be monitored on a recurring basis rather than on the periodic schedule currently being used. For those foreign nationals requesting access to Tier 1 BSAT, the panel suggested that the Department of Justice investigate the feasibility of obtaining criminal background checks from the researchers' home countries.¹

Related to laboratory security, FESAP made several technical recommendations for increasing the physical and cyber security of facilities that work with biological select agents and toxins. The panel noted that some laboratory facilities that perform functions vital to national security, such as those that participate in the Laboratory Response Network (LRN), may require additional security measures.

FESAP is chartered through July 2, 2014, and will continue to refine their recommendations for the select agent list based on the most current information. The panel also will continue to review the evidence base for personnel reliability recommendations and will provide technical consultation regarding the Select Agent Program on request. ¹

Cameron Ward

IOM Examines Ways to Advance Regulatory Science for MCM Development

The U.S. Department of Health and Human Services' (HHS) review of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) in August 2010 concluded that, in order to improve the speed, agility, capacity, and success of medical countermeasures development (MCMs), investment in innovative regulatory science is needed.

In response to the PHEMCE review, the U.S. Food and Drug Administration (FDA) established a 3-part MCM initiative to enhance and modernize its approach to evaluation and regulation of MCMs. At FDA's request, the Institute of Medicine (IOM) conducted a joint workshop in March 2011 with its Forum on Drug Discovery, Development, and Translation and its Forum on Medical and Public Health Preparedness for Catastrophic Events, to help inform FDA's approach to regulating MCMs.¹ The objectives of the IOM workshop were to:

• Provide a broad overview of current efforts under way at FDA and other agencies in HHS and the Department of Defense (DoD) to support the research, development, evaluation, and production of MCMs;

Proceedings and major findings of the workshop, published on June 15, 2011, focused on 4 broad areas of regulatory science:

First, the IOM solicited the perspectives of relevant MCM stakeholders, including the FDA's Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH); DoD; the National Institute of Allergy and Infectious Diseases (NIAID); the Biomedical Advanced Research and Development Authority (BARDA); the Centers for Disease Control and Prevention (CDC); academia; and industry. ¹

Second, the workshop examined, in detail, scientific efforts to advance MCM regulatory science, including nonclinical approaches to assessing the efficacy of an MCM, safety and safety monitoring issues, the need for new antimicrobials, and the role of rapid diagnostics. The workshop also addressed advancements in vaccine science and adjuvants, recommending that an adjuvant advisory group be convened to work through adjuvant-specific issues. Additional discussions were held on systems biology, synthetic biology, and new platform technologies. Finally, the workshop covered improvements to statistical approaches in drug development and clinical trials to facilitate regulatory evaluation of MCMs. ¹

As the third broad area of focus for the workshop, participants considered MCM regulatory science needs for at-risk populations. Participants considered some of the unique vulnerabilities of children and pregnant women, including respiratory rates of children, sensitivity to different doses of infectious agent or MCM, and differences in the blood-brain barrier. Participants recommended that specific formulations, biomarkers, and models for understanding and addressing the threats to these populations be developed. ¹

Finally, the workshop addressed some of the crosscutting themes and future directions for advancing regulatory science. One such theme was the interest in platforms that are not yet approved by the FDA but that could streamline MCM development in the future. Another theme was the need for better communication among industry, regulators, and other stakeholders. Specifically, participants found that BARDA and FDA need to clarify their roles in the different stages of MCM development. ¹

Kunal J. Rambhia