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Medical Countermeasures for Smallpox

The Threat

valSmallpox (Variola virus) is considered a high-priority biological threat agent. It can be spread using an aerosol spray, transmitted from person to person via close contact, and can survive in the environment up to one day, depending on ambient conditions. The fatality rate following infection is high, and there is no effective, approved treatment. Routine smallpox vaccination ended in the U.S. in 1972. Those who received the vaccination may experience a reduction in symptom severity and a decreased mortality rate, however, the infection rate and spread of disease amongst the general population is expected to be high.

On September 23, 2004, the Secretary of Homeland Security determined that the smallpox virus is a material threat to the U.S. population sufficient to affect national security. Because the threat is credible and smallpox has the potential to cause significant casualties and massive disruption of political, economic, and social infrastructures in the U.S., strong efforts to reduce U.S. vulnerability to smallpox are warranted. As such, BARDA is supporting the development of both vaccines and antivirals that can protect against or treat smallpox. An effective antiviral treatment could mitigate the effects of smallpox disease. It is likely that such an antiviral may also be effective against other pox viruses.

Smallpox Medical Countermeasure Efforts

As part of its programmatic activities, BARDA is supporting the development of both vaccines and antivirals that can protect against or treat smallpox. An effective antiviral treatment could mitigate the effects of smallpox disease. It is also likely that such an antiviral may also be effective against other pox viruses. Given the current status of the most advanced products as well as the status of animal model development, HHS will pursue a mid-term acquisition of a smallpox antiviral for the treatment of smallpox. The ideal antiviral will be highly effective post-exposure as well as an effective treatment early in the symptomatic phase of the disease.

In 2007, BARDA entered into a contract to develop of the smallpox vaccine IMVAMUNE®. This is an attenuated smallpox vaccine which is also designated for individuals with weakened immune systems.

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BARDA’s near-term strategy for anthrax vaccines leverages funding to support improvements in the utility and capability of BioThrax®. Significant progress toward this goal includes delivery of BioThrax® to the Strategic National Stockpile (SNS) under PBS funding and submission in late 2014 of the Supplemental Biologics License Application (sBLA) for post-exposure prophylaxis (PEP) indication, with anticipated FDA licensure in 2015. Projects are ongoing to expand the vaccine’s label indication for post-exposure prophylaxis, increase the current U.S. manufacturing production capacity and support the development of an enhanced vaccine formulation candidate with adjuvant (NuThrax®) that may produce a more rapid immune response with fewer doses required for protection. NuThrax® will enter Phase 3 clinical development in 2015 and potentially transition to procurement under PBS later in the decade. Successful execution of this near-term strategy may have a significant impact on U.S. preparedness against an anthrax attack and provide a substantial reduction in costs across the PHEMCE.

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Other investments in smallpox advanced research and development include:

  • In 2011, BARDA entered into a contract with Chimerix, Inc. to support development of CMX-001, a broad spectrum antiviral. CMX-001 has the potential to treat variola virus infection (causative agent of Smallpox) as well as infections caused by double-stranded DNA (dsDNA) viruses like adenovirus, cytomegalovirus, and BK virus.
  • In 2011, the National Institute of Allergy and Infectious Diseases (NIAID) transitioned to BARDA the SIGA advanced research and development contract supporting "Expanded Utility and Additional Indications" for the antiviral ST-246 against smallpox disease. BARDA is now managing the contract awarded by NIAID in September 2008. BARDA is providing technical and financial support for the development of an intravenous (I.V.) formulation and post-event prophylactic (PEP) treatment indication for ST-246.
  • In 2011, BARDA also contracted with SIGA Technologies, Inc. for the development and procurement of treatment courses of ST-246. This contract for late stage development and procurement is funded through Project Bioshield.

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