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Impact of Critical Biosecurity Reports – Uncertainty Remains

Domestic Preparedness published an article in 2016 discussing the uncertain impact of several biosecurity reports on national planning and preparedness for biosecurity and pandemic threats. The article focused on the consistent and repeated warnings of the consequences for failing to plan and prepare for a multitude of biosecurity threats. The identified inferior planning and preparedness concerns were as apparent and repetitive as the demonstrated lack of reaction to them in the past. The nation was vulnerable.

One of the most critical reports was released by the Blue Ribbon Study Panel on Biodefense in 2015, entitled A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts. The report was comprehensive and thought-provoking by identifying and re-enforcing numerous vulnerabilities and inadequacies regarding the planning and preparedness for a myriad of biosecurity, biodefense, and public health threats. The blue ribbon panel report identified 33 recommendations and 87 action items for national leaders and policy makers to consider and implement, but any coordinated national response to them remained to be seen in 2016.

From the blue ribbon panel report to several other important public health studies and findings addressing the Ebola virus and other outbreaks discussed in the article, it remained apparent that a whole-of-community approach was required to plan and prepare for these biosecurity threats. The article concluded with:

Time shall tell if we as a nation choose to be proactive or reactive for biodefense, biosecurity and public health threats. The blueprints and frameworks surely exist to educate, support and prepare us for the next serious black swan event. Our failures shall not be from a lack of knowledge or warning, but prioritization, planning and preparedness.

Time did tell. The answer was found in the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel virus that caused the COVID-19 pandemic. The nation and world did not demonstrate a sufficient level of planning and preparedness for the novel zoonotic virus and the consequences were staggering on countless levels. Many somber cascading consequences that shall drastically affect lives, economies, and geopolitics around the world are likely still months or years away.

Biodefense in Crisis

The Bipartisan Commission of Biodefense, previously known as the Blue Ribbon Study Panel on Biodefense, issued the report Biodefense in Crisis: Immediate Action Needed to Address National Vulnerabilities in 2021. This follow-up report identified the observable results of failing to consider their 2015 observations and guidance. According to the report:

Regrettably, most of the Commission’s recommendations were unaddressed or only partially addressed before the COVID-19 pandemic began. Had the government fully implemented A National Blueprint for Biodefense or responded to warnings from experts, the Nation would have been much better prepared for COVID-19. Our recommendations would not have prevented infectious disease, but their adoption would have greatly assisted the federal government and its state, local, tribal, territorial, and non-governmental partners in preventing COVID-19 from becoming a pandemic.

The 2021 report stressed that, five years after the original report, the United States remained at catastrophic biological risk. The report focused its action items on the categories of leadership, coordination, collaboration, and innovation.

Leadership

As clearly demonstrated by SARS-CoV-2leadership was one of the most lacking areas for the prioritization of focus and resources. There were scores of strategies, reports, studies, and other warnings stressing the need for leadership that were ignored for decades. National Security Presidential Memorandum 14, issued in 2018, was another attempt to coordinate and implement a strategy for national biodefense. The assistant to the president for National Security Affairs was designated as the lead for policy coordination and review along with the secretary of the Department of Health and Human Services chairing the Biodefense Steering Committee. The steering committee was responsible for monitoring and coordinating the implementation of the 2018 National Biodefense Strategy. The 2021 report faulted this strategy, citing that it was difficult for one department to successfully direct other independent departments and agencies for the execution of the national strategy. It was yet another example of responsibility without clear authority and power to drive policy and action.

The first 2021 report action item was a recommendation for the president to “establish a dedicated Deputy National Security Advisor for Biodefense, overseen by the Vice President of the United States and supported by NSC staff in a Directorate for Global Public Health Security and Biodefense and a Directorate for Domestic Public Health Security and Biodefense.” This recommendation would elevate the importance of the mission and enhance the powers of the assignees to encourage coordination and cooperation.

The Trust for America’s Health supported this concept in their report Ready or Not: 2021 Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. The report recommended the creation of “a White House Health Security Directorate, including senior advisors to the president with public health expertise on health security issues. This directorate would oversee the national biodefense strategy and all interagency emergency responses.”

It is unknown if this elevated level of authority would truly create responsibility within the departments and agencies for genuinely successful and coordinated efforts. It has been an enormous challenge as far back as the National Strategy for Pandemic Influenza and even well before that seminal document.

Coordination

None of the previous processes for the coordination of biodefense strategies and activities over the past decades was overly successful. The 2021 report identified them all as flawed. The recent response to SARS-CoV-2 only reinforced their observations. The Biodefense Steering Committee reportedly did not possess all of the required stakeholders and subject matter experts to properly address the exploding pandemic – including state, local, tribal, territorial, and private sector partners. An action item was recommended to create a federal advisory committee with other partners to advise the Biodefense Steering Committee. It is unknown if one more advisory committee with vague authorities would be a solution.

It was recommended to establish a broader implementation plan for the National Biodefense Strategy to better achieve its mission, goals, and objectives. The stronger plan would identify tangible activities, milestones, and timelines for completion for each specific goal and objective for enhanced accountability. The report again identified the challenges with coordinated and coherent congressional oversight and recommended for Congress to better focus on the vast and critical subject. As in 2015 and many years before and after, that essential recommendation was easier said than done. In the present political environment, it appears even less likely to succeed.

One of the most important recommendations for future threats may be the subject of biological attribution as demonstrated most recently with SARS-CoV-2. With the stakes being enormously high, the timely and accurate attribution of a biological incident or attack would be critical for the appropriate response. As stated in the report, “the implications of imposing sanctions and embargoes, cutting off diplomatic relations, and declaring war are too important to leave to a loose set of occasional federal players and policies.” The attempt to identify and confirm the actual origins of SARS-CoV-2 clearly demonstrated the difficulty of establishing biological attribution. Attribution can be incredibly difficult in the cyber environment; the physical world may be even more arduous.

It was recommended for Congress to instruct the executive branch to develop, plan for, and establish a national biological attribution apparatus to inform decision-making. Once again, transitioning from coordination to collaboration on such a complicated subject may be easier said than done – even in a post COVID-19 world.

Collaboration

Beyond coordination, outreach and collaboration with nonfederal stakeholders for biosurveillance are essential according to the report. The National Biosurveillance Integration System was created to aggregate, analyze, and disseminate biosurveillance information from inside and outside the federal government. However, according to the report, too few federal departments and agencies provide information to the system or value the issued products from it. The system and its National Biosurveillance Integration Center (NBIC) were routinely criticized for reportedly failing to meet its designated mandates and responsibilities.

According to a United Sates Government Accountability Office (GAO) 2009 report, NBIC was not fully equipped to carry out its mission because it lacked key resources – including data and personnel from its partner agencies, which created serious challenges. The findings were similar in a 2015 GAO report identifying continued limited participation from its partners for information and personnel. GAO identified five options for the improvement of NBIC. Subsequent reviews have not indicated inspiring progress.

The 2021 report recommends that Congress should direct the Department of Homeland Security to conduct a comprehensive assessment of the National Biosurveillance Integration System to determine its performance and identify any additional authorities required to execute its responsibilities. However, a review of the numerous biosurveillance reports released by GAO indicated that various assessments have already occurred and identified a variety of options and recommendations for improvement. Another assessment without mandated and tangible actions could just add to the list of disregarded or unimplemented recommendations.

Planning and preparedness for COVID-19 were lacking despite adequate warning. Will the same happen for the next biosecurity threat to include bioterrorism?

Innovation

Medical countermeasures were identified as another area requiring improvement for development and multi-year funding. For example, Project BioShield was created in 2004 to accelerate the research, development, purchase, and availability of effective medical countermeasures against weapons of mass destruction – including biological, chemical, radiological, and nuclear agents. The government recognized that pharmaceutical companies were not developing these unique medical countermeasures without an existing and profitable market to underwrite their substantial investments. The companies needed financial encouragement, which Project BioShield and other legislation provided. The 2021 report recommended another comprehensive review of medical countermeasures programs, policies, and assets.

Along with Project BioShield, the 2021 report recognized that the current BioWatch Program technology performed poorly and was far from the deterrence mechanism it was originally intended to be when the program was established in 2003. According to the report, BioWatch detectors, when they work, only provide useful data hours or days after an event. The BioWatch Program provides air-monitoring, analysis, notification procedures, and risk assessment support to over 30 jurisdictions across the nation to minimize the catastrophic impact of a biological attack. The BioWatch Program has been discussed in numerous assessments by GAO and other organizations identifying key areas of concern. The limited number of detectors with uncertain detection capabilities may not be the vital tripwire needed to identify an emerging biological attack. The 2021 report recommended that “Congressional appropriators should deny further funding for BioWatch activities until proven replacement technology is identified and confirmed to meet the needs of the program.”

Report Findings

The Bipartisan Commission of Biodefense provided a review and assessment of the implementation status of the 33 recommendations and 87 actions items from their 2015 report. They found that only three of the action items were completed and partial action was taken for 54 action items. Reportedly no action was taken for 24 action items. Due to COVID-19, emergency action was reportedly executed for 6 action items without evidence of permanent policy or planning changes for future threats.

The 2021 report concluded with:

The Commission urges policymakers to learn from the COVID-19 pandemic and address critical gaps in the Nation’s biodefense, without waiting for COVID-19 to disappear, and before we find ourselves facing the next infectious disease pandemic or biological attack.

To further encourage interest and progress, the Bipartisan Commission of Biodefense created an interactive webpage to track and update the commission recommendations and action items. The proactive measure was a shrewd idea to maintain active focus on the recommendations and action items for prioritization and advancement and not wait until the next report years from now.

The fundamental findings from the 2015 and 2021 reports provide a foundational roadmap for biodefense planning and preparedness. The guidance was not only for public health threats from naturally occurring pandemics but for possibly even more serious threats from bioterrorism and biowarfare from state and non-state actors. The nation’s overall performance for a novel zoonotic disease with a mortality rate of approximately one percent was not impressive. The response to an intentional biological attack with a much more lethal and directed pathogen may be even less impressive without serious motivation and progress.

Beyond Novel Viral Pandemics

From the 2012 National Strategy for BioSurveillance to the National Biodefense Strategy, the government continued to clearly identify the biosecurity threats to the nation and world. The goals of the National Strategy for BioSurveillance were to achieve a well-integrated national biosurveillance enterprise that saves lives by providing essential information for better decision-making at all levels of government. The National Biosurveillance Science and Technology Roadmap was released in 2013 to support the strategy by identifying and prioritizing research and development needs with the goal of giving decision-makers at all levels of government more accurate and timely information when biological incidents threaten health. These strategies were distributed well before the COVID-19 pandemic outbreak without substantial observable preparedness results.

The National Biodefense Strategy addressed deliberate and accidental biological threats along with naturally occurring biological threats. According to the strategy, “nation-states and terrorist groups have found value in pursuing biological weapons, and there can be no confidence that will change in the future.” Through its five goals and linked objectives, the strategy established a layered risk management approach to biological threats. Included in the goals was to disrupt plots, degrade technical capabilities, and deter support for terrorists seeking to use weapons of mass destruction. The current and future threats include a great deal more than naturally occurring epidemics and pandemics.

With technological advancements, the creation of dangerous and lethal pathogens becomes considerably less complicated for researchers with good and bad intentions. The reconstruction of the 1918 pandemic influenza virus in a laboratory was fascinating and frightening at the same time. The ability to create a strain of the polio virus in a laboratory with publicly available information and materials, along with other similar scientific developments, provide substantial reason for concern and consideration. The expanding scientific advancements are genuine and cannot be ignored.

The amazing capabilities derived from CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) to edit genes shall surely enhance medical advancements and magnify concerns for bioterrorism and biowarfare in the future. Either from an advanced laboratory or a musty basement, the next pathogen may become a much more significant threat to the world than SARS-CoV-2 with drastically higher morbidity and mortality rates.

Time Shall Tell

Once again, time shall tell if the nation chooses to be proactive or reactive for biodefense, biosecurity, and public health threats. After SARS-CoV-2, the correct answer should be obvious. However, the concerns and signals were evident to many after the previous emergence of SARS, MERS, Ebola, H1N1, and other high-profile pathogenic warning shots over the past two decades with incredibly modest planning and preparedness results.

The previous and new reports, strategies, and frameworks continue to educate, support, and prepare the nation for the next biological black swan event. Bioterrorism attacks and biowarfare may be as close as COVID-19 was less than two years ago – just over the horizon. Once more, future failures shall not be from a lack of knowledge, warning, and recent experience, but prioritization, planning, and preparedness.

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Robert C. Hutchinson

Robert C. Hutchinson, along-time contributor to Domestic Preparedness, is a director at Black Swans Consulting LLC. Before joining the private sector, he was the chief of police for the Broward County Public School, Special Investigative Unit. He retired after over 28 years as a federal agent with the U.S. Department of Homeland Security and the U.S. Department of the Treasury. His positions included deputy director, assistant director, deputy special agent in charge, assistant special agent in charge, supervisory special agent, and special agent at offices in Florida, Washington DC (HQ), Maryland, and Texas.  He was the deputy director of his agency’s national emergency preparedness division and assistant director for its national firearms and tactical training division. His over 40 publications and many domestic and international presentations address the important need for cooperation, coordination, and collaboration between public health, emergency management, and law enforcement, especially in pandemic preparedness. He received his graduate degrees at the University of Delaware in public administration and Naval Postgraduate School in homeland security studies.

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