Smallpox Research Oversight Activities: WHO Advisory Committee on Variola Virus Research

Smallpox is an acute contagious disease caused by variola virus, a member of the Orthopoxvirus genus.

It was one of the world's most feared diseases until it was eradicated by a collaborative global vaccination program led by the World Health Organization.

The last known natural


case was in Somalia in 197 7. Upon eradication, all existing stockpiles of the virus were moved, by international agreement, to two ÂœWHO International Collaborating Centers.

The Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, USA, and the State Research Center of Virology and Biotechnology, Novosibirsk, Russia.

Under this agreement, any and all work with variola virus by either group must be directly approved through an oversight committee established by the WHO.

The WHO Advisory Committee on Variola Virus Research (ACVVR) was established in 1999 to determine what essential research, if any, must be carried out with live variola virus.

The ACVVR monitored the research progress in order to reach global consensus on the timing for the destruction of existing variola virus stocks.

In 2007, the World Health Assembly (WHA) requested the ACVVR undertake a thorough review of the approved research program with a report presented in 201 0. The results were presented at the 64th WHA meeting in May of 201 1. The ACVVR continues to serve a critically important function for global public health, and to oversee research.

The U. S. Government supports the development of medical products, including vaccines and drugs, for use within the U. S. upon verification of a smallpox case.

The U. S. government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies, which require access to the variola virus to satisfy regulatory requirements for product approvals.

The U. S. maintains a need to work directly with the virus for its strategic needs in developing medical countermeasures, such as safer vaccines, new antiviral agents, and better diagnostic systems as a defense against potential bioterrorism threats, thus strengthening our national security.

A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005).

A case of smallpox detected by a member state requires notification to WHO as soon as possible, and any confirmed smallpox case would generate an immediate global public health response.

Since May 1999, when the 52nd World Health Assembly (WHA) resolved to postpone the destruction of the variola virus to allow for this essential research (WHA 5 2. 10), WHO has been charged with convening a group of experts to advise on the need for continuing such research, to review proposals for research involving viable variola virus, to review the progress of such research, and to report to the WHA each year.

The need to support the activities described in this FOA has not changed.

The variola virus research and stocks destruction are expected to be substantive agenda items at the 70th World Health Assembly in 201 7. ASPR will provide a single source cooperative agreement to support the WHO Advisory Committee on Variola Virus Research to advise WHO on all activities in respect to variola virus research and the biosafety inspection of the variola virus repositories.

The only eligible awardee is the World Health Organization (WHO).

This FOA will only support non-research activities supported by HHS.
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