The Blue Ribbon Study Panel on Biodefense’s “National Blueprint for Biodefense” warned that “the United States is underprepared for biological threats,” adding that “biological events may be inevitable, (but) their level of impact on our country is not.”
To combat a biological event, either manmade or a naturally occurring threat such as the recent Ebola outbreaks, the study said that the United States needs to focus on biodefense.
“Biodefense touches many aspects of society, falling within the purview of national security, homeland security, public health security and economic security,” the report said. “As such, it requires an enterprise approach – eliminating stovepipes; transcending agency-centric activity; drawing upon stakeholders throughout government, academia and the private sector; and recognizing the extraordinary breadth of the challenge – to provide flexible solutions that address the full spectrum of the threat.”
Maryland-based Emergent BioSolutions is one of the stakeholders working on biodefense.
“Emergent is a global specialty biopharmaceutical company focused on developing and manufacturing bioterrorism countermeasures,” Chris Frech, senior vice president of global government affairs at Emergent, said. “We focus on the threat issues identified by the U.S. government that pose a risk to the public and to the men and women in our military. We take our mission to ‘protect and enhance life’ seriously and we develop products to support that mission. Our first product was BioThrax, the only FDA-licensed vaccine, which back then was only for pre-exposure protection against anthrax. We have grown from there .”
To date, three million U.S. military personnel have received the BioThrax vaccine. BioThrax is now also licensed for post-exposure prophylaxis of anthrax disease. BioThrax is part of the Strategic National Stockpile (SNS), which would be used by the government to protect the public in the event of a national emergency.
“It is hoped that it will never be used, but we have large quantities of it (stored in the SNS),” Frech said. “In 1998 the Department of Defense realized that anthrax was a threat to the troops so they made vaccination mandatory for all of the troops. There is now a Strategic National Stockpile from which vaccines are used to administer to the men and women in the military.”
“There is a surplus of the vaccine that expires before it is used. One of the proposed ideas emerging from the Blue Ribbon Study Panel on Biodefense was to make these short-dated vaccines available on a voluntary basis to first responders and that is also something we are pursuing.”
The First Responders Anthrax Preparedness Act, H.R. 1300, introduced by U.S. Rep. Peter King (R-TX), would do just that.
Enacting other recommendations from the Blue Ribbon Study Panel on Biodefense should be another priority this year, Frech said, including increasing flexibility and incentivizing private companies to enter the biodefense space, as well as identifying and expanding the understanding of current threats and their appropriate countermeasures.
“A big part of that is raising awareness on Capitol Hill,” Frech said. “The Ebola crisis was a teachable moment for our country and for members of Congress and others involved in biodefense. Ebola brought to light a number of concepts, including the importance of investment, procurement, ongoing development and stockpiling vaccines. It opened up the opportunities for members of Congress and others in this field to address how we can do things better in the future.
“The silver lining of the Ebola crisis was that it awakened a sleeper issue and reminded everyone of the importance of being prepared. Zika is doing that again and is forcing us to examine our preparedness and response.”
To determine what products to develop and what products to stockpile, Emergent turns to the yearly HHS “Material Threat List,” which contains a list of what the government has identified as the biggest threats to the nation.
“[B]ased on that list, we can evaluate what vaccines need to be developed or which need to be stockpiled,” Frech said. “The threat risks on the list are usually classified as low probability but high consequence events that would be catastrophic if they occurred.”
Frech added that “we are in a very dynamic and dangerous time” and that the threat against the U.S. is growing, not diminishing. Despite that, however, “each year, we are better prepared than the last,” he said.