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U.S. Department of Health and Human Services


Fifteen Years, Fifteen Stockpiled Medical Countermeasures: Leveraging Project BioShield to Build an Unprecedented Array of Drugs, Vaccines, Therapeutics, and More to Enhance Health Security

Author: Gary Disbrow, Ph.D., BARDA Deputy Director
Published Date: 7/24/2019 8:36:00 AM
Category: Medical Countermeasures;

When Project BioShield was signed into law 15 years ago, the nation had few medical countermeasures to rely on in national emergencies. In the interceding years, BARDA has worked with its partners throughout government and industry to find creative solutions to address health security threats. Together, we have developed safe and effective medical countermeasures to protect the public in emergencies.

BARDA has supported 27 projects using Project BioShield authorities and funding. We’ve added 15 products to the Strategic National Stockpile. We’ve worked with industry partners to achieve FDA approval of 10 of those products and to make the others available under Emergency Use Authorization from the FDA. In 15 years, that’s unprecedented!

The commitment of Project BioShield shows what government and private industry can do for the American people when we work together. We’ve developed a broad portfolio of medical countermeasures to address such diverse threats as Ebola, anthrax, botulism, smallpox, nerve agents, radiation, thermal and radiation burns.

Some of the medical countermeasures supported under Project BioShield are being used to enhance global health security by addressing the ongoing Ebola Virus Disease outbreak in the Democratic Republic of Congo. Secretary of Health and Human Services Alex Azar recently described the current Ebola outbreak as one of the department’s top global health priorities. He cautioned the current Ebola outbreak is unlikely to be the last and noted that investing in vaccines today either will help defeat this outbreak or be vital to beginning the response to the next one.

BARDA is supporting late-stage development of two Ebola vaccines with the goal of vaccine licensure. One of these vaccines is being used as part of a voluntary ring-vaccination campaign to help protect more than 162,000 people in the current outbreak. In addition, two Ebola therapeutics being supported under Project BioShield are being used as part of an ongoing randomized clinical trial in the Democratic Republic of Congo.

We also are using Project BioShield funds to develop medical countermeasures that address burns and blast trauma, two potentially deadly consequences of nuclear incidents. Almost half a million people in the U.S. suffer from burn injuries every year leading to about 40,000 hospitalizations. The products being developed under Project BioShield will address the medical needs and treatment challenges associated with burns to improve the quality of care every day and in disasters.

By developing products we need for emergency response and leveraging their daily use in the commercial market, we reduce the tax payers’ cost of development and of stockpiling and stimulate an important financial return on investment for private partners. In addition, healthcare providers become familiar with how to use the products so they’re comfortable using them in national emergencies.

With recent legislation and new initiatives, we’re poised to build on that success for years to come. The commitment to preparedness has to be continuous and, because of Project BioShield, the U.S. healthcare system is increasingly prepared to respond to disasters and save lives. That’s the most important return on investment.


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