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BARDA and Project Bioshield Progress Report Details Core National Security Role

Amesh A. Adalja, MD, FACP, FACEP, FIDSA, February 17, 2017

In order to further the national security of the United States and fortify it against an intentional attack using biological weapons—as occurred in 2001 with anthrax—Congress and President George W. Bush created Project Bioshield in 2004. Project Bioshield was tasked with facilitating the development, acquisition, and stockpiling of diagnostics, vaccines, and medications against chemical, biological, radiological, and nuclear (CBRN) threats. Initially funded with $5.6 billion for a 10-year period and reauthorized in 2013, Project Bioshield, and the related Biomedical Advanced Research Development Authority (BARDA), recently published a 10-year progress report on their efforts in this field in Clinical Infectious Diseases.

 

6 CBRN Licensed Products

In the report, Larsen and Disbrow catalog the products BARDA and Project Bioshield have supported. Achievements that are highlighted include 80 candidate countermeasures, 21 stockpiled countermeasures, and 6 FDA approvals for CBRN indications. 

Included in the FDA approval are 2 monoclonal antibodies for anthrax, which represent the first licensed monoclonal antibodies for a bacterial infectious disease, as well as the heptavalent botulism antitoxin and a postexposure prophylaxis dosing regimen for the existing anthrax vaccine. Additionally, several nonlicensed but important products have been developed and stockpiled and would be used under an emergency use authorization. These include a smallpox antiviral and a smallpox vaccine to be used in people for whom the standard vaccine is contraindicated. 

Radiation countermeasures have also progressed under BARDA/Project Bioshield stewardship, with both biodosimetry devices and cytokines being supported. Stockpiling of an antimicrobial burn dressing, development of burn eschar dissolving agents, and development of skin growth/regeneration products have also occurred.

In the chemical realm, a midazolam auto-injector, to be used in the event of nerve gas poisoning, is in late stages of development.

 

Essential to National Security

Over a decade has passed since the anthrax attacks of 2001; preparedness has increased substantially since that time, and defense against CBRN threats has become melded into national security. Both BARDA and Project Bioshield are essential elements of national security, and, especially in light of a change in presidential administration, it is important to emphasize the critical role these agencies have had in fortifying the nation against intentional CBRN threats. Larsen and Disbrow note, however, that despite the reauthorization of Project Bioshield in 2013 with annual funding at $2.8 billion (from 2014-2018), that funding is subject to annual congressional appropriations; as such, only a fraction of that funding has been appropriated. 

If resilience to ever-present CBRN threats is to be maintained and expanded, BARDA and Project Bioshield should be recognized and adequately supported for the national security role they have played and will continue to play.

 

Reference

Larsen JC, Disbrow GL. Project Bioshield and the Biomedical Advanced Research Development Authority: a ten year progress report on meeting U.S. preparedness and objectives for threat agents. Clin Infect Dis 4 Feb 2017. https://academic.oup.com/cid/article/2967925/Project-BioShield-and-the-Biomedical-Advanced. Accessed February 15, 2017.