First Smallpox Vaccine for Special Populations Delivered Under Project BioShield

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project
BioShield contract.

Under this contract the Danish company Bavarian Nordic is manufacturing and delivering 20 million doses of its next generation smallpox vaccine known as modified vaccinia Ankara (MVA) or Imvamune. Delivery of the first million doses began in May and deliveries will continue through
2013. The contract is administered by the Biomedical Advanced Research and Development Authority, BARDA, a part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

In an emergency, such as the virus being obtained from a secure lab and used in an act of terrorism, the vaccine may be authorized for use to protect people who have weakened immune systems, specifically HIV persons who have not progressed to AIDS. Addressing the needs of such special populations is mandated under the Pandemic and All-Hazards Preparedness Act (PAHPA).

The Strategic National Stockpile (SNS), operated by the Centers for Disease Control and Prevention (CDC), has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.

Project BioShield gives BARDA the contracting authority to develop and procure medical countermeasures against chemical, biological, nuclear and radiological threat agents. In 2007, Bavarian Nordic was awarded a $505 million contract to develop and deliver the MVA smallpox vaccine to the SNS. This contract was the first to use advance and milestone payments under Project BioShield as modified by PAHPA.

"This product began with a basic research and development program initiated by the National Institute of Allergy and Infectious Disease at the National Institutes of Health in 2003, and progressed to the point that Project BioShield could be used for further development and procurement," said BARDA Director Dr. Robin Robinson. "It represents a concerted, coordinated effort among federal agencies and with the private sector throughout the R&D process. It's a model for us going forward."

As a next step, BARDA is supporting Bavarian Nordic's work to improve the product further by developing a freeze-dried version of Imvamune. The freeze-dried formulation may have an improved shelf-life, reduced storage costs, and simplified transportation logistics compared to the
current vaccine formulation.

U.S. government agencies including BARDA, CDC, the National Institutes of Health, the Food and Drug Administration, and the Department of Defense have collaborated to develop requirements and policies, provide guidance, and work with manufacturers to develop and procure smallpox
medications and vaccines - known as medical countermeasures - for the SNS.

BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing
infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, and pandemic influenza, and emerging infectious diseases. For additional information, visit www.hhs.gov/aspr.

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