Although the WHO declared smallpox eradicated worldwide in the 1980s, the virus remains a potential global security threat. BARDA Director Rick Bright explains how this new vaccine is part of HHS’ commitment to guard against health security threats.
Developed and manufactured by Bavarian Nordic A/S of Denmark, initial research on the vaccine was funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, in 2003, and transitioned to the Biomedical Advanced Research and Development Authority , part of the HHS Office of the Assistant Secretary for Preparedness and Response, for late-stage development support in 2007, under.
Throughout the clinical development of the vaccine, FDA’s scientific and regulatory expertise and advice to Bavarian Nordic ensured an application inclusive of clinical and non-clinical data that would support the vaccine’s safety and effectiveness for the prevention of smallpox.
During the later stages of clinical development, partnerships with the Centers for Disease Control and Prevention and the Department of Defense supported licensure of the vaccine. ASPR began stockpiling the vaccine in 2010 to make it available for special populations, if needed, under an Emergency Use Authorization from the FDA. This is an example of the commitment and work by both agencies to support the availability of critical medical products under the authorities available to FDA. We will continue to stockpile the vaccine and work with Bavarian Nordic on licensure of a lyophilized formulation of the vaccine that has a longer shelf life.
One of BARDA’s goals is to work with our industry partners to obtain FDA approval for their products that prepare our nation against health security threats. We are honored to have helped achieve that goal with Bavarian Nordic A/S for JYNNEOS, which is the 49product supported by BARDA to achieve FDA approval in the past 12 years.
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