Public Health Emergency - Leading a Nation Prepared
Seeking to protect all populations following a bioterrorism attack involving smallpox, the U.S. Department of Health and Human Services will purchase a lyophilized (freeze-dried) smallpox vaccine for women who are pregnant or nursing and people of any age with HIV or atopic dermatitis.
Using Project BioShield funding, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR), will purchase the vaccine from Bavarian Nordic headquartered in Denmark over a period of five years for a total of $100 million.
“A critical component of preparedness is making sure effective medical countermeasures are available for a range of populations” said BARDA Director Rick Bright, Ph.D. “In addition to the long-term cost savings realized with extended shelf-life, this vaccine could help protect certain populations for which other stockpiled smallpox vaccine may be less appropriate.”
Pending its approval by the U.S. Food and Drug Administration (FDA), the lyophilized vaccine could be used during a public health emergency involving smallpox if the FDA allows for its use under an emergency mechanism. The vaccine is a freeze-dried formulation of the liquid frozen vaccine already stockpiled by the U.S. Government. While the liquid frozen vaccine has a limited shelf-life, the lyophilized vaccine is expected to be stable over a longer period of time, resulting in lower life-cycle costs for taxpayers.
In clinical studies to date, this two-dose vaccine regimen has been tested safely in over 7,000 people. Studies have also shown that the safety and immune response of the lyophilized vaccine are comparable to the stockpiled liquid-frozen vaccine.
The vaccine’s development began with support from the National Institute for Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and transitioned to BARDA in 2009 for support of the vaccine’s advanced stages of development. The U.S. biodefense goal for smallpox is to have two vaccines and two antiviral drugs developed and FDA approved.
BARDA has the option of using Project BioShield funding to support any additional studies needed for the company to apply for FDA licensure of the lyophilized vaccine formulation and to make additional purchases of the vaccine. Pursuing these options would bring the total to more than $539 million. The Project BioShield Act of 2004 allows BARDA to research, develop, and purchase medical countermeasures such as vaccines, therapeutics and diagnostics.
This vaccine’s development and purchase is part of BARDA’s integrated portfolio for the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. For more information about advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov.
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