First Smallpox Vaccine for Special Populations Delivered Under
Project BioShield
14 July 2010
HHS (U.S. Department of Health & Human
Services)
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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