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U.S. Department of Health and Human Services


Crossing the Finish Line: Project BioShield is Transforming the Nation’s Health Security with Cutting-Edge Innovation, Sound Investments, and Strong Partnerships

Author: Rick A. Bright, Ph.D., BARDA Director
Published Date: 8/7/2019 10:53:00 AM
Category: Medical Countermeasures; Innovations; National Health Security;

Project BioShield is revolutionizing the way we protect Americans from 21st century health security threats. Think back almost 18 years ago to the anthrax attacks of 2001. That crisis highlighted just how few medical countermeasures our nation had to respond to a bioterrorism incident. The anthrax attacks taught us important lessons that still guide our thinking:  innovation is critical, partnerships matter, and the threats that we face are very real and very serious.

21st Century Health Security Threats: From Anthrax to the Unknown

Although we have developed medical countermeasures to address some of the injuries and illnesses caused by many the most pressing national health security threats, challenges remain. Some of the injuries or illnesses remain as risks; some threats and their impacts remain unknown.

Since 2001, our understanding of the threat space has evolved and we have worked with our partners across government, notably within the Department of Homeland Security, to better understand the threats our nation faces. Improving the available medical countermeasures to address 21st century health security threats is a national security imperative.

Threat Wheel

As directed in the National Biodefense Strategy, we are continuing to enhance preparedness to ensure health security and save lives. We are expanding our portfolio of medical countermeasures to address the remaining threats and to counter new and unknown threats.

We are better prepared today than we were 15 years ago because of sound investments in biodefense made using Project BioShield, strong partnerships, and a shared commitment to cutting-edge innovation. Project BioShield is our commitment to accelerate product development and ensure availability of those products for Americans.

A Portfolio Approach to Medical Countermeasure Development

The anthrax attacks of 2001 brought our needs into sharp focus: we didn’t just need a vaccine. To save lives in a future bioterrorism attack, the nation needed an array of medical countermeasures, including diagnostic tests to inform triage and treatment; post-exposure vaccine to provide quick protection against infection; antitoxins to counteract the toxic effects of the bacteria; and next-generation antibiotics. Today, BARDA supports a broad array of medical countermeasures not just against anthrax but also to combat the health effects of other chemical, biological, radiological, and nuclear threats.

Unique Approach to Partnerships

Developing novel medical products can require decades and billions of dollars in the private sector, and the same is true of medical products needed for national security. As a nation, we have accomplished much in a relatively short time due to strong and long lasting public-private partnerships. Project BioShield isn’t just a funding mechanism; BARDA also provides technical expertise and resources. We have a network of organizations to assist product developers with non-clinical and clinical studies. We have a network of companies that provide formulation and fill-finish manufacturing services to get vaccines and other products into vials or syringes for ease of use in communities during crises. And our expert staff may be our greatest resource of all, providing technical recommendations based on decades of experience.

BARDA also uses unique authorities provided to us to forge partnerships with companies to develop entire portfolios of products. Using this portfolio approach, each company works with BARDA to decide which products move in and out of their joint development portfolio to serve commercial and national emergency needs. Our expectation is that products advance to be supported under Project BioShield to save lives in emergencies.

Transforming the Future of Health Security

To invest public funds wisely, BARDA focuses on products that have commercial market potential as well as emergency uses whenever possible. We look for partners on development portfolios, and look for solutions to some of our nation’s most daunting health security challenges. The future for Project BioShield is to broaden our commitment to Americans to be ready in America’s darkest hour.  With Project BioShield and our partners, we can decrease the negative health consequences from  health security threats and save lives.


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