Smallpox Research Oversight Activities: WHO Advisory Committee on Variola Virus Research | Apply Online

Opportunity Summary:

This funding opportunity, titled "Smallpox Research Oversight Activities: WHO Advisory Committee on Variola Virus Research," is a U.S. Department of Health and Human Services (HHS) cooperative agreement administered through the Office of the Assistant Secretary for Preparedness and Response (ASPR). It focuses on supporting the World Health Organization (WHO) in its formal oversight role for any work involving live variola virus, the virus that causes smallpox. Even though smallpox was eradicated through a WHO-led global vaccination campaign and the last naturally occurring case was recorded in Somalia in 1977, two official repositories of the virus still exist under international agreement. Those repositories are located at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and at the State Research Center of Virology and Biotechnology in Novosibirsk, Russia. Because these are the only authorized locations holding the virus, and because the stakes are exceptionally high, any research using viable variola virus must be reviewed and approved through WHO-established oversight.

The core purpose of the award is to support the ongoing work of the WHO Advisory Committee on Variola Virus Research (ACVVR), which was created in 1999. The ACVVR exists to answer a difficult global question: what, if any, essential research still requires live variola virus, and when should the remaining virus stocks be destroyed. Since the World Health Assembly (WHA) decided in 1999 (WHA resolution 52.10) to postpone destruction of the stocks to allow essential research, WHO has been responsible for convening experts to evaluate whether continued research is justified, to review and assess proposals that involve viable variola virus, to monitor progress and outcomes from approved work, and to provide regular reporting back to the WHA. The committee has also conducted major program reviews when directed, including a thorough review requested by the WHA in 2007, with results ultimately presented to the 64th WHA meeting in May 2011. The opportunity notes that variola research and the question of destruction of remaining stocks were expected to be significant agenda items for the 70th WHA in 2017, highlighting that this oversight function remains active and politically and scientifically consequential.

A major driver described in the announcement is public health preparedness and national security. While a natural re-emergence of smallpox is considered not possible, the document emphasizes that an intentional or terrorist release would be catastrophic, triggering an immediate international response and meeting the definition of a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (IHR 2005). Under those regulations, any suspected or confirmed smallpox case must be reported promptly to WHO, and confirmation would prompt rapid global coordination. Against that backdrop, the U.S. Government maintains strategic reasons to continue certain work that depends on access to the live virus, particularly to meet regulatory expectations tied to medical countermeasure development. ASPR describes U.S. efforts to develop and maintain vaccines and to advance antiviral drug candidates and diagnostics, noting that some product development and approval pathways require testing that involves variola virus. The ACVVR oversight framework is therefore presented as a necessary mechanism to ensure such work is tightly controlled, justified, and aligned with global governance expectations.

Importantly, this specific funding opportunity is not meant to pay for laboratory research itself. It explicitly supports non-research activities, meaning the administrative, technical, and governance functions that allow WHO and the ACVVR to operate: convening expert meetings, reviewing and tracking proposals and approved projects, documenting outcomes, coordinating with the authorized repositories, and supporting biosafety-related oversight, including inspection activities connected to the variola repositories. In other words, the award is designed to fund the structure of oversight and accountability rather than experiments or product development in a lab.

The award is structured as a single-source cooperative agreement, reflecting both the collaborative nature of the work and the fact that only one organization is eligible to receive it. The only eligible awardee is the World Health Organization, because WHO is the body mandated by WHA resolutions to convene the committee, manage the review process, and report back to Member States. The funding listing identifies the opportunity as discretionary, under the Science and Technology and other Research and Development category (even though the supported activities are non-research oversight), with CFDA number 93.019. The expected number of awards is one, with an award ceiling of $300,000.

Key administrative details include the funding opportunity number (EP IDS 16 007), the sponsoring agency (HHS/ASPR), the posting date (June 22, 2016), and the original closing date (August 22, 2016). Applications were required to be submitted electronically through Grants.gov by August 21, 2016 at 11:59 pm Eastern Time. Overall, the opportunity is essentially a targeted federal investment in global smallpox governance: sustaining the WHO-led system that authorizes and monitors any remaining use of live variola virus, supports biosafety assurance at the only two authorized repositories, and helps maintain international consensus and transparency around a pathogen that remains a high-consequence security concern even after eradication.

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