Since its creation in 2006, the Biomedical Advanced Research Development Authority (BARDA) has taken a lead role in helping to procure an arsenal of medical countermeasures that the agency says should serve as a deterrent to anthrax, smallpox and botulism being weaponized in a future biological attack.
After letters laced with anthrax were sent by mail in 2001, killing five Americans in the worst biological attack in U.S. history, the U.S. government strengthened its national preparedness position against chemical, biological, radiological and nuclear (CBRN) threats.
BARDA, part of the U.S. Health and Human Services Department, recently published a 10-year progress report on its efforts to meet U.S. preparedness goals for CBRN threats.
“Ten years ago we would have had no ability to respond to a radiation event or a mass burn event,” Joseph Larsen, acting deputy director of BARDA, told Homeland Preparedness News in a recent interview.
“And for some of these threats now – particularly for smallpox, botulism and anthrax – we’ve made such progress that we can begin to talk about being prepared sufficiently for those threats and then begin to pivot and focus on other threats that are now outstanding,” he added.
Over the next five years, BARDA will ramp up its investment in two key areas: medical countermeasures for viral hemorrhagic fevers like Ebola and chemical threat agents.
BARDA was an active participant in the response to the Ebola outbreak in West Africa beginning in 2014. “… It’s absolutely critical that we finish the late stage development and stockpile and get approved or license both an Ebola therapeutic and an Ebola vaccine to protect the American public from the potential of future outbreaks of that virus,” Larsen said.
Chemical weapons such as nerve agents also top the list of potential CBRN threats, highlighted by the use of VX, the nerve agent authorities said recently killed Kim Jong-nam, the half brother of North Korea’s leader Kim Jong-un.
BARDA is in the process of preparing to stockpile the anti-seizure medication midazolam in an autoinjector that would treat the effects of nerve agents on the neurological system. The product from Pfizer Inc. subsidiary Meridian Medical Technologies is expected to be available for use in emergencies by 2018.
“We also see threats like mustard as well as chlorine gas, as is being used in the Syrian conflict, as major areas where we need to make our research and development more robust so that we can begin to transition programs into Project BioShield in the 2018-2023 timeframe,” Larsen said.
The Project BioShield Act of 2004 created a funding vehicle to speed up the research, development and stockpiling of vaccines and treatments that could be tapped during public health emergencies, like a CBRN terrorism attack. BARDA directs funding toward providing economic incentives for pharmaceutical and biotechnology companies to create medical countermeasures.
In the last decade, BARDA has procured and stockpiled 21 products for use in potential public health emergencies. Six of those products have been approved by the U.S. Food and Drug Administration (FDA) and more approvals are expected in the next couple of years.
Anthrax preparedness is one threat that BARDA has thoroughly addressed. BARDA’s investments have resulted in three FDA-approved products for inhalational anthrax and one vaccine that can be used as a post-exposure prophylaxis countermeasure.
BARDA also has made investments in the late stage development and procurement of NuThrax, a next generation anthrax vaccine from Emergent Biosolutions Inc. NuThrax will provide protective immunity after two doses versus the three for the currently stockpiled vaccine, “which will lower the total life cycle cost of that vaccine and save the U.S. taxpayers money because it will cost us less to maintain that preparedness,” Larsen said.
Vaccines and antiviral drugs for the treatment of smallpox also have been stockpiled for a declared emergency.
In addition, BARDA supported the development and procurement of the only available therapy for botulism. It is routinely used in foodborne outbreaks of botulism that occur in the United States, but also could be deployed in the event of an attack with botulism.
Another area where progress has been made is in the ability of the nation to respond to an improvised nuclear device or dirty bomb.
“We now have procured cytokine products, which are traditionally used to treat patients that are experiencing the effects of chemotherapy and radiation when they have cancer, and we’re leveraging off that commercial market to make procurements and investments in products that we can use to treat the effects on the body of acute ionizing radiation,” Larsen said.
Technologies also have been developed that allow doctors to detect how much radiation a victim has potentially absorbed into their body. The agency plans to procure two different types of these biodosimetry devices in late stage development to diagnose the level of radiation a person has been exposed to.
The need to treat burn injuries is another critical component of preparedness efforts related to radiological or nuclear attacks. In the last year BARDA procured four products that help treat burn injuries. Silverlon, a metallic silver-based antimicrobial wound dressing from Argentum Medical, has been approved by the FDA and stockpiled.
Meanwhile, three other products that would allow for an improved standard of care for burn wounds are in late stage development. One product involves an artificial skin substitute to minimize skin grafting.
CBRN threats aside, BARDA is grappling with the challenges of not being able to reliably predict its level of funding from year to year.
The current $2.8 billion that was authorized for BARDA and Project BioShield from 2014-2018 is annually appropriated by Congress under the Pandemic All Hazards Preparedness Reauthorization Act. But so far, less than two thirds of the total funding has been appropriated.
“Having stability in our funding would be very advantageous to allow us to strategically plan future procurements and acquisitions,” Larsen said.
After products are licensed and approved, the new set of challenges becomes sustaining companies that have made investments in developing medical countermeasures for CBRN threats. Because many of those products cannot be sold in the commercial marketplace, it becomes difficult to sustain companies that are developing products where the majority of their revenues are directly tied to procurements by the U.S. government.
Larsen asked, “How do maintain that it is still a priority to keep stockpiled typically hundreds of thousands of units of product to keep the American public safe?”
“If we can’t create an environment where companies want to continue making these products, they aren’t going to make them,” he added.