When a bioterrorist attacked in September 2001 by sending anthrax through the mail, our nation awoke to the fact that we were ill-prepared to fight bioterrorism. Although bioterrorism attacks are high impact with stark health consequences, in the United States, such attacks have been low frequency, so pharmaceutical companies had no incentive to invest the millions of dollars necessary to develop drugs and other medical products. Yet, our nation needed to be better prepared for these threats and able to protect the health of Americans should an attack occur.
The federal government needed a way to entice companies to develop the drugs, vaccines, diagnostic tests, and medical devices to save lives following a chemical, biological, radiological or nuclear (CBRN) attack. Federal agencies also needed funding to stockpile these products to use in an emergency.
Recognizing this necessity, Congress passed the Project BioShield Act of 2004. Through Project BioShield, BARDA has supported the late-stage development and procurement of 21 medical countermeasures – the drugs, vaccines, and medical devices that our nation would use to protect Americans following a CBRN emergency.
Developing and procuring critical medical countermeasures
Project BioShield helped to accelerate the research, development, purchase, and availability of effective medical countermeasures against CBRN agents. In 2004, there were few effective medical countermeasures available for purchase. BARDA has worked extensively with partners across government through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to coordinate efforts to develop these drugs, vaccines, therapeutics and devices.
Of the 21 medical countermeasures supported under Project BioShield, 14 have been added to the Strategic National Stockpile for use in the event of an emergency. Six of these products are licensed or approved by the FDA. Several more products are expected to achieve approval by the FDA in 2017 and 2018.
Project BioShield has been used to procure medical countermeasures that can be used by at-risk populations. A Project BioShield-supported botulinum antitoxin is now licensed for pediatric use and has been used to treat naturally occurring cases of botulism in infants, children, adults, and elderly patients in the United States and Mexico. Under Project BioShield, ASPR/BARDA sponsored development of three anthrax antitoxins that are now licensed or approved with pediatric dosing recommendations and purchased the products. ASPR/BARDA purchased radiation medical countermeasures that can be used to treat children as well. The program also procured a smallpox vaccine that could be given to people with HIV or atopic dermatitis as well as to pediatric patients and nursing or pregnant women.
Supporting research and development
Developing medical countermeasures is a lengthy process, and ASPR/BARDA has worked with its PHEMCE partners to strengthen the medical countermeasures development pipeline. ASPR/BARDA has supported over 80 advanced research and development projects and many of these candidates have transitioned to ASPR/BARDA from other PHEMCE partners. Promising products supported under ASPR/BARDA’s advanced research and development program have transitioned and are now supported under Project BioShield; ASPR/BARDA can purchase the products that reach FDA approval or could be used under emergency use authorization from FDA.
The Path Forward
The successes of Project BioShield and the improved coordination under the PHEMCE have attracted the attention of pharmaceutical companies large and small. Partnerships with these companies are vital to ensuring that we implement sustainable preparedness programs.
Since 2004, Project BioShield has made significant progress in preparing the nation to respond to a variety of CBRN attacks, but gaps still exist and there is much work to be done. The Project BioShield program, as part of an integrated PHEMCE, is poised to address challenges and fill gaps so that we can be better prepared to protect health and save lives in the event of a CBRN emergency.
