By Robert Herriman @bactiman63
US and global health security-what is it, what was the genesis and how prepared are we? These are some of the things I look at in this interview with experts in the field.
In this email interview, I discuss a number of important topics with U.S health security industry expert and CEO of SIGA Technologies, Dr. Phillip Gomez, and infectious disease expert and SIGA Chief Science Officer, Dr. Dennis Hruby.
Health security is a topic most people don’t think about except in the most unusual of times, like 2001 and this year as examples. Can you give a definition of health security and what are the origins of health security policy in the US and globally?
The Center for Health Security at the Johns Hopkins Bloomberg School of Public Health has a mission “to protect people’s health from epidemics and disasters and ensure that communities are resilient to major challenges.” We think that’s a great way to define the space. Additionally, as the COVID-19 pandemic has shown, infectious diseases have significant potential to harm both physical and economic health. Consequently, the mission statement for the Center for Infectious Disease Research and Policy at the University of Minnesota also offers a useful framework for defining health security focused on disease prevention: “…to prevent illness and death from infectious disease threats through research and the translation of scientific information into real0-world, practical applications, policies and solutions.”
In the United States, the understanding of health security as a specific area for government policy and investment has been around for several decades, but President George W. Bush and Barack Obama each had personal experiences that may have helped to push health security to more prominent positions in their respective administrations. The 2001 anthrax attacks occurred during George W. Bush’s time in office, as did the “Dark Winter” exercise, which simulated a smallpox biologic attack on the United States and showed that such an attack would lead to massive civilian casualties and civil disorder. In 2005, President Bush read John M. Barry’s “The Great Influenza” about the 1918 flu pandemic, which had a profound impact on his view of the need for a national strategy to address infectious disease outbreaks that had the potential to kill hundreds of thousands of people. These experiences may have informed policy decisions, including the development of the first comprehensive pandemic plan in the United States, the passage of the Project BioShield Act of 2004, and the 2006 passage of the Pandemic and All-Hazards Preparedness Act, which established the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services.
In 2005, then Senator Obama visited a pathogen laboratory in Ukraine, and was stunned to see vials of anthrax and plague stored with minimal security. In a speech given not long after he returned from that trip, he spoke of the need for “sustained involvement by the Executive Branch, Congress, non-governmental organizations, and the international community” to prevent the use of these and other similar stocks as bioterror weapons. As President, Mr. Obama’s administration was challenged with a massive Ebola outbreak in Africa and the H1N1 flu epidemic here at home. In 2016, his administration established a Directorate for Global Health Security and Biodefense at the National Security Council, underscoring health security as a component of our national security.
These are examples of how U.S. health security policy is driven not only from the bottom up in terms of data-based risk assessments, but also by the personal experiences of Presidents and others in prominent government leadership positions, which combine to inform a necessary, comprehensive approach to address health security.
Globally, there has generally been less formal policy around health security, although we expect that may change in response to the current COVID-19 pandemic.
Health security gained a large spotlight during the 2001 anthrax attacks. How has it evolved over time during the past two decades?
We believe that there has been tremendous progress with respect to health security policy and resources, but this progress has occurred at a slower pace than many of us in the space would have liked. A key challenge in terms of advancing the vaccines, therapeutics and diagnostics that are essential for responding to pandemic health threats is that these products almost always lack a natural commercial market. In SIGA’s case, we invested along with significant US Government funding in developing, manufacturing and securing FDA approval for a product that we truly hope will never be used for its current indication of treating active smallpox infections. A key policy challenge over the years has been how to effectively and efficiently incentivize companies to invest and innovate in these areas without a clear sustainable market.
Fortunately, the landscape of public-private partnerships between government agencies and companies in the health security space has continued to evolve in order to spur and support the innovation we need to meet our health security objectives. Push incentives, such as research funding through entities such as the National Institutes of Health (NIH) or the Department of Defense (DoD), provided support for early research into the biology of leading health threats and the identification of molecules and targets that could anchor product development efforts. Purchase guarantees, under which government agencies commit to purchasing products that are successfully developed, can serve as an incentive for companies with resources on hand to get products across the finish line. They are less helpful for companies that lack these resources. A key driver for the establishment of Project BioShield was the recognition that a promise from the government to purchase a product wasn’t necessarily sufficient to secure the often substantial private-sector investments that companies needed to fund drug development, manufacturing and approval activities, and could not do so alone without Government investments in those activities as well.
BARDA is charged with helping private sector companies cross the financial “valley of death” between NIH funding for early-stage research and the actual deployment of health security assets that have been procured. BARDA works collaboratively with the NIH, the Center for Disease Control (CDC), the Food and Drug Administration (FDA), DoD, Department of Homeland Security and private companies to establish true public-private partnerships that can meet U.S. health security needs. Since its inception in 2006, BARDA has supported the development of 55 products that have received FDA approval, licensure or clearance.
What is Project BioShield?
The Project BioShield Act of 2004 established Project BioShield as a program of the Department of Health and Human Services “to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents,” which is now overseen by BARDA. It encompasses three key sets of activities: funding the purchase of critical medical countermeasures, facilitating research and development through NIH grants and contracts, and facilitating the use of medical countermeasures during an emergency. This last activity included the establishment of Emergency Use Authorization (EUA), which has played a critical role in expediting the availability of tests, therapies and vaccines to address the COVID-19 pandemic.
Who are the major players in health security both here and abroad?
The U.S. government is probably the biggest single entity actively engaged in health security from both policy and budgetary perspectives. Additionally, currently there are nearly 20 companies that are members of the Alliance for Biosecurity, an international coalition of biopharmaceutical companies and laboratory/academic partners that promotes public-private partnership to ensure medical countermeasures are available to protect public health and enhance national health security. The Alliance includes large pharma companies, such as Sanofi Pasteur, GSK and Roche, as well as smaller companies, such as SIGA. Additionally, other companies have stepped into focus with the COVID-19 pandemic, like Pfizer, Moderna and BioNTech.
Health Security not only focuses on medical countermeasure for threats like smallpox and anthrax, but also therapies and vaccines for influenza; diagnostics, therapies and vaccines for emerging infectious diseases; and addressing therapies for growing antimicrobial resistance to approved products. This includes a wide range of companies involved in these Health Security challenges.
In a 2017 talk at the Munich Security Conference, Bill Gates encouraged more countries to focus on health security, noting that “the Ebola epidemic might have been much worse if the U.S. and UK governments had not used military resources to help build health centers, manage logistics, and fly people in and out of affected countries.” These investments in infectious disease as a national security issue highlight the importance of government investments as we prepare for the next threats.
Even prior to the COVID-19, more countries were focusing on pandemic preparedness as a component of their national security priorities, and we believe the current experience will likely increase the pace with which countries and regional cooperative organizations take more concrete step toward implementing strategies for and investing in pandemic preparedness measures.
SIGA Technologies is one of the players, particularly with TPOXX® (tecovirimat) approved for the treatment of smallpox, which could provide significant potential benefit in the event of a smallpox pandemic or outbreak. What is TPOXX® and why is smallpox of particular concern to the U.S Government?
TPOXX® (USAN tecovirimat, ST-246), a small molecule therapeutic, is the first FDA-approved drug that is specifically indicated for the treatment of smallpox disease. Smallpox is a particular concern to the U.S. and other governments because it has the potential to be used as a bioweapon. Although naturally occurring smallpox was eradicated in 1980 after decades of intensive and coordinated vaccine campaigns, laboratory stocks of variola, the virus that causes smallpox still exist. Russia and the United States are known to have viral stocks, but there is concern that other governments or entities may hold unaccounted stocks that might be accidentally released or used for bioterror purposes. Additionally, in 2017 researchers in Canada announced that they were able to recreate horsepox virus, an extinct virus in the same family as variola, for only $100,000 using mail-order DNA. Given that the gene sequence for variola is in the public domain, there are concerns that a terrorist organization could synthesize the virus de novo.
Today we are witnessing first-hand the human and economic toll of the COVID-19 pandemic, and SARS-CoV-2, the virus that causes COVID-19 is likely less lethal and less infectious than variola. Current estimates suggest that each person infected with SARS-CoV-2 can infect 2-2.5 other people; based on data from prior to the eradication, each person with smallpox may infect 5-7 other people. Smallpox can be spread through speaking, breathing or touching and through contact with contaminated objects and fluids from an infected person. Another concerning aspect of smallpox infection is that it can have asymptomatic spread, just as we are seeing with COVID-19. Symptoms of smallpox don’t appear until 14 days after infection, during which time infected individuals unaware that they are infected can transmit the virus to others. Additionally, although the data continue to evolve, SARS-CoV-2 appears to have a fatality rate of less than 3%, while smallpox historically had a fatality rate of up to 30%. So there’s a great sense of urgency within the U.S. government to be prepared to respond to a potential smallpox outbreak.
Being prepared for smallpox includes having vaccines and therapeutics on hand for immediate deployment in response to an outbreak. The Strategic National Stockpile (SNS) has both, including TPOXX. TPOXX would be particularly important following an outbreak, as vaccination would need to occur within 3-5 days of becoming infected to provide protection – a time during which symptoms would not yet have occurred. Additionally, the growing number of vaccine skeptics in the United States might limit the number people willing to be vaccinated.
TPOXX is currently approved to treat active smallpox infection. However, we are conducting studies in collaboration with the DoD to develop TPOXX for use in post-exposure prophylaxis (PEP). In PEP, TPOXX would be given to people with known or expected smallpox exposure in order to reduce morbidity and mortality.
What do you believe to be the risk and potential for a smallpox bioterror attack?
There are multiple government and non-governmental agencies in the United States and abroad that are focused on health security risk assessments. These assessments include both the likelihood that an event will happen as well as the impact the event would make. The CDC and NIH currently list smallpox as a Category A Bioterrorism Agent.
In two separate talks in 2017, Bill Gates raised concerns about the potential devastation of a smallpox bioterror attack, noting that “the next epidemic could originate on the computer screen of a terrorist intent on using genetic engineering to create a synthetic version of the smallpox virus,” and that it “would not only kill millions, it could potentially kill billions.”
Let’s talk about health security preparation in 2020. Where do we stand nearly 20 years after the anthrax attacks and what lessons are we learning from the current COVID-19 pandemic?
We believe that there’s been significant progress in establishing public/private partnerships that stimulate the innovation we need to address current and future health security threats. More needs to be done in this realm to encourage additional players to participate in these important undertakings. The COVID-19 pandemic has also shown that the SNS is under-stocked and underfunded. We need sufficient quantities of effective medical countermeasures in the SNS, as well as protocols for how to distribute what’s available to achieve maximum impact and benefit to our citizens. Availability alone without coordinated operational plans will hamper effective deployment and response. While BARDA and BioShield have done a great job supporting the development of new countermeasures, the SNS needs sufficient funding to procure them, or the result may be lost opportunity for preparedness. SIGA is pursuing expansion of the number of TPOXX doses in the SNS, because the 1.7 million that are currently available would be insufficient if we actually face a smallpox outbreak.
Earlier this year, Tom Cole a Congressman from Oklahoma who is the top Republican on the House Appropriations subcommittee on Labor, Health and Human Services and Education, advocated for increasing baseline spending on pandemic defense programs, saying “I think, honestly, spending billions to save trillions is a no-brainer to me, and I think that’s where we’re at.” This is an important recognition that we need to ensure the Strategic National Stockpile has sufficient diagnostics, therapies, vaccines, and devices to deploy in the event of an emergency.
COVID-19 has been a wake-up call that we need to re-think what health security actually means and what it takes to achieve it, and that we may be vulnerable to health security risks that arise anywhere in the world.
Lastly, how will the current pandemic alter healthcare going forward?
There have been many lessons learned on multiple fronts. For one, the pandemic highlighted just how vulnerable global supply chains are to border closures. Pharmaceuticals, testing reagents and personal protective equipment often comprise components or handling in multiple countries, and border closures can have catastrophic impacts on the ability to get health security assets to where they are needed in a timely fashion. The entire supply chain for TPOXX is within the United States, and we believe that more companies – in health security and other industries – are going to pay closer attention to the physical location of the suppliers on which they rely.
We also expect that other countries will take steps to keep the production of critical health security assets within their own borders or within regional cooperative groups. Toward this end, we think it likely that members of the international community will develop their own cooperative versions of BARDA serving countries within Europe or Asia.
The pandemic also emphasized the importance of having resources where and when they are needed and a process for prioritizing distribution of these resources to achieve maximum impact. While the SNS will always be a critical component of our national health security strategy, we believe that some states may consider establishing their own stockpiles of critical health security assets. Toward this end, SIGA is evaluating a potential label expansion for TPOXX that would allow us to sell directly to states or large healthcare providers and could increase these organizations’ ability to respond to smallpox outbreaks in their communities.
Finally, the current pandemic has highlighted how health crises have the capacity to bring the entire world economy to a halt. We expect that will spur essential investment in health care and preparedness in the US and worldwide for the foreseeable future.
Any final thoughts?
COVID is just the most recent respiratory virus that has significantly threatened not just our health but our economy and the foundations of our society as well. The prior SARS and MERS epidemics burned themselves out, but COVID-19 reminds us that emerging viruses must be taken seriously before they take root in our communities. This pandemic also underscores that effective, consistent and reliable communication is critical to addressing health security challenges. Recent surveys suggest that half the U.S. population might not take a COVID-19 vaccine if one becomes available. Skepticism about vaccines is decreasing vaccination rates and increasing our risks for spread of diseases that the generations before us fought valiantly to contain. Companies and governments can invest trillions of dollars and decades of research into developing the assets we need to address our health security challenges. But if people won’t use them, we all remain at risk.