The world looks different than it did 20 years ago yet the need to protect the American people remains just as urgent. It’s time to step back and acknowledge a milestone in the protection of the American people against serious public health threats. This July we mark the 20th anniversary of the Project BioShield (PBS) Act. Signed into law on July 21, 2004, the Act allows the U.S. government (USG) to accelerate development of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats to our national security.

The essential gains over the last two decades would not have happened without crucial USG funding and authorities granted under Project BioShield. Both are essential for the Biomedical Advanced Research and Development Authority (BARDA) to establish public-private partnerships to develop the products needed to protect these potentially deadly threats. Vital to the program’s success has been the interagency collaborations with the National Institutes of Health and the Department of Defense which supported the early-stage development of products that transitioned to support with BARDA under Project BioShield.

Over the past 20 years, we have leveraged over $12 billion of Project BioShield funding to expand our portfolio of medical countermeasures, which strengthens national security preparedness against some of the most pressing national security threats. By developing and procuring products under PBS, we can be sure they are available during emergencies, which means the U.S. is better positioned to tackle current and future challenges. Overall, we have supported 39 products using PBS authorities and related funding. Three of the products were already FDA approved and purchased under PBS to address radiation and nuclear threats in 2004-2005. Of the other 36 products, 22 have progressed to FDA approval under the FDA’s Animal Efficacy Rule or through a traditional approval process; two products are available and regulated under a different mechanism; and six are now in late-stage development.

PBS was established to improve national security, preparedness, and response. While we all hope that a CBRN emergency will never happen, the investments made under PBS mean these products will be available if needed. The products we supported and procured under PBS have made a positive impact on public health. In fact, one of BARDA’s aims is to develop products that can prevent, diagnose and treat patients during major incidents but also have more immediate, day-to-day public health uses, such as cancer treatment and severe burn case. Some of the products have been used in emergencies, such as:

• The first FDA approved vaccine and therapeutic to address Ebola virus deployed to multiple outbreaks in Africa.
• A smallpox vaccine for at-risk populations and two smallpox antivirals used to curb the mpox outbreak.
• Heptavalent botulism antitoxin deployed to address naturally occurring cases of botulism.
• Anthrax antitoxins deployed to treat cutaneous anthrax.

The biggest challenge facing these public-private partnerships is sustainment. Sustained funding and the authorities granted under Project BioShield and PAHPA are essential to maintain sufficient stockpiling of medical countermeasures and ensure access to manufacturing capabilities for production of additional products if required during a CBRN emergency. The United States is stockpiling the majority of these essential products and will need international partners, agencies and organizations to leverage the significant investments made by the USG and support procurement of essential MCMs. Additional procurements by other governments and/or the private sector can expand manufacturing capabilities that are currently only able to support the USG requirements. BARDA will continue to work within USG and with congress, international counterparts, and industry partners to address ongoing challenges in protecting health security.

The PBS Act was intended to bolster national security against CBRN threats. We have overcome scientific and regulatory challenges in the past 20 years, and as a result, our nation is better prepared for health security threats.

Visit the Project BioShield site to learn more about the legislation and how BARDA is leveraging PBS in three main approaches to biodefense.