Militarizing Global Health Isn’t the Right Answer
In 1990, I was a chemical officer stationed at Aberdeen Proving Ground when I was told to prepare for a potential deployment to Saudi Arabia. It seems that there was a conflict brewing with an adversarial nation that had a significant chemical and biological weapons program, and my skills were in demand (for a change). In anticipation of the deployment, I received two anthrax vaccination shots before the conflict blew over. It was not until years later that I learned that the Department of Defense was struggling with significant shortfalls of anthrax and botulinum toxin vaccines. There was one small company in Lansing, Michigan, producing all of the U.S. military’s vaccine stock, and there wasn’t enough for the total force. The botulinum toxin vaccine was provided only to special operations forces, although a crash program at Fort Detrick had started on producing more. The Army medical research community does have a long track record of developing vaccines for natural infectious diseases, which affected far more servicemembers every year than biological warfare agents. But it was unprepared for Iraqi biological warfare agents in 1990.
Now, 30 years later, the Pentagon is poised to make the same mistake as it did then. The American public was recently informed of “Operation Warp Speed,” which has the lofty goal of providing “substantial quantities of a safe and effective vaccine” to 300 million Americans by January 2021. Instead of U.S. health officials, however, the U.S. military is in charge of the program. Unfortunately, this effort will leave no one well served, whether you are an American who fears COVID-19 or you want to be confident that the U.S. military will be able to face future bio-threats, which have featured prominently in warnings from the intelligence community.
By militarizing the government’s accelerated program to produce a vaccine in six months, it is possible that the effort will divert resources and attention away from the mission of developing chemical and biological defense equipment for the military. In addition, by excluding the Department of Health and Human Service’s agencies, the government’s efforts are ignoring the traditional experts in developing and implementing public health measures.
Engage Warp Drive
COVID-19 is an emerging infectious disease, a novel coronavirus that has caused considerably more incapacitations and deaths than seasonal influenza. But it is a naturally occurring disease, and most people would like to have a vaccine for it so that they could go back to some level of pre-crisis normalcy.
Let’s start with how the federal government is supposed to respond to a pandemic, by design and according to law.
Congress designated the Department of Health and Human Services through the Public Health Service Act to lead the federal response to public health emergencies. Under that department’s jurisdiction, the National Institutes of Health oversees the National Institute of Allergy and Infectious Diseases, which has a strategic plan for COVID-19 research. The assistant secretary for preparedness and response, also of the Department of Health and Human Services, oversees the Biomedical Advanced Research and Development Authority (BARDA). Since 2004, this agency has been responsible for developing and procuring medical countermeasures for public health threats, to include emerging infectious diseases, and putting them into the Strategic National Stockpile. In addition, BARDA funded three Centers for Innovation in Advanced Development and Manufacturing, whose purpose is to provide a domestic infrastructure capable of rapidly producing medical countermeasures. These public-private partnerships are necessary given that much (if not all) of commercial vaccine development has moved overseas. Over the past few months, BARDA has been instrumental in developing new partnerships with industry to develop diagnostics, medical vaccines, and therapeutics for COVID-19.
This sounds like a great vehicle to develop a COVID vaccine, right?
President Donald Trump does not seem to agree. He announced Operation Warp Speed as a vaccine development project to rival the Manhattan Project in its scope. And of course, since an Army general officer was in charge of that project, that must mean that an Army general officer has to be in charge of this one. Gen. Gustave Perna, commander of the U.S. Army Materiel Command, was chosen to lead the task force along with Moncef Slaoui, a venture capitalist who used to work for GlaxoSmithKline, a major pharmaceutical company based in the United Kingdom, and who currently sits on the boards of multiple vaccine developers. So now the Army’s top acquisition officer and “Big Pharma” are working hand in hand on a $10 billion race to the cure.
According to media reports, this project is co-chaired by the secretaries of Health and Human Services and the Defense Department. A detailed project framework lays out the multiple teams of the Warp Speed organization. It shows three leadership positions, all from Health and Human Services — one each for developing vaccines, therapeutics, and diagnostics. The first two will be filled by senior leaders from the Food and Drug Administration, and the last by the director of the National Institute of Biomedical Imaging and Bioengineering (under the National Institutes of Health). These three health officials will lead five technical teams, all matrixed from the Department of Defense.
The diagnostics team and therapeutics team will be led by the Defense Health Agency, the military’s organization for managing all of the medical treatment facilities in the United States through a $31 billion budget. The task of leading production and distribution goes to the principal deputy assistant secretary of defense for acquisition enablers (a new office under the under secretary of defense for acquisition and sustainment) and two teams from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, which is the acquisition arm of the Chemical Biological Defense Program. The latter two teams include a brand-new vaccine development and acquisition office identified as “enabling biotechnologies” and something called “security and assistance” that requires a “chief intelligence officer” — for a natural disease project.
But what about the Department of Health and Human Services agencies?
BARDA and the National Institutes of Health still have billions of dollars appropriated by Congress to spend in addition to whatever these teams execute. But the Warp Speed teams have no representatives from BARDA or the National Institute of Allergy and Infectious Diseases, and no participation from the Centers for Disease Control and Prevention.
The Defense Department Is Not a Best Practice
After the failure to have adequate amounts of vaccines for the Persian Gulf War, the Department of Defense mandated that the Army’s medical research and development community would have to spend funds allocated for biological warfare vaccines based on a list of validated biological warfare agents. The department created a Joint Program Office for Biological Defense in 1994 to fast-track the development of biological detectors (separate programs for the Army and Navy) and to upscale the anthrax vaccine program. This office became part of a Joint Chemical Biological Defense Program, which began to develop joint chemical biological defense equipment for the military in 1996. For the first 10 years, about all that came out of the program was an improved version of the anthrax vaccine and a lot of scientific studies on potential vaccine candidates.
There was one significant project that stood out in the Chemical Biological Defense Program. The Transformational Medical Technologies Initiative was started in 2006 in an attempt to move more than a billion dollars over eight years through science and technology efforts to develop broad-spectrum medical treatments. This meant that military servicemembers might require only one drug that would protect them from all dangerous bacteria, or from all hemorrhagic fevers, or perhaps from genetically altered diseases. Defense leadership was unwilling to provide funds for the project, so funds were moved from existing traditional chemical and biological defense modernization programs. This meant significant delays for fielding chemical detectors and individual protective equipment and for researching new decontamination and collective protection equipment.
The funds were dispersed to over 20 companies and government laboratories, and after 10 years of research, the result was disappointing to say the least. The only promising technology that had come out of the project was a platform that might allow for developing a countermeasure to the flu — not a biological warfare agent, but something of interest to the domestic vendors. Another part of the program had evolved to create products for a joint bio-surveillance and response system for which no branch of the military had provided requirements. Neither product advanced the military’s biological defense capabilities. Other than that, it was a great experience for science and technology researchers.
Between 2009 and 2016, hundreds of millions of research and development dollars continued to be diverted from traditional chemical and biological defense programs to global bio-surveillance and medical diagnostics projects that lacked service sponsorship but were touted as addressing national guidance. This trend continued to delay vital programs that the services needed to modernize their capabilities. The Chemical Biological Defense Program did move forward on some critical biological warfare vaccines. Over the past 10 years, the program fielded vaccines for botulinum toxin, plague, Rift Valley fever, and Venezuelan equine encephalitis. All of these currently have investigational new drug applications, meaning they have not been tested for efficacy in humans. They have been used in animal models, and there is good reason to believe they will work. But one still needs to sign a waiver stating that one understands the risk of using the vaccine as a pre-treatment for exposure to biological warfare agents. Over a 20-year period and after spending billions of defense dollars, the Department of Defense has a half-dozen vaccines against the (roughly) one dozen dangerous pathogens listed on the CDC’s Category A priority list. This is not a process that can be rushed.
The Chemical Biological Defense Program also likes to note its contribution to the Ebola vaccine. You might remember that the U.S. military contributed to the massive U.S. response to West Africa’s Ebola outbreak in 2014. Most of the work was conducted by the Department of Health and Human Services and the U.S. Agency for International Development, but the military likes to remind people that it was there, too. The Chemical Biological Defense Program had been working on an Ebola vaccine since 2001. Additional funds and energy were applied after 2014, and that finally bore fruit at the end of 2019 when the Food and Drug Administration approved the vaccine Ervebo to be produced by the giant pharmaceutical firm Merck and Co. Ebola was on the list of validated biological warfare agents, but this vaccine is licensed for the natural disease outbreak. Eighteen years of work, and an extensive partnership with BARDA, industry, and the Canadian government, resulted in a good product. But why would the American public trust the Department of Defense to effectively execute a multibillion-dollar defense acquisition program to deliver hundreds of millions of vaccine doses within a six-month period given this track record? It defies logic. And let’s not even get into the department’s general record of managing major defense acquisition programs.
The Army’s Medical Research and Development Command at Fort Detrick, Maryland, does in fact have a Military Infectious Diseases Research Program for emerging infectious diseases (Army-funded) as well as a Medical Chemical Biological Defense Research Program (funded by the Chemical-Biological Defense Program). The “enabling biotechnologies” office created for Operation Warp Speed will be located at Fort Detrick, but it is unclear to what extent these existing teams will be part of the new work. At the least, the animal testing facilities at Fort Detrick will be used to support clinical trials. The Defense Advanced Research Projects Agency also has a Biological Technologies Office that does work like this, but it’s more prone to investing in high-risk, high-reward projects with industry that are not expected to have a near-term release. None of this is done in a short time frame. Anything to do with medical research takes years to complete, and for good reason. You don’t want an ineffective or unsafe medical treatment introduced into a community that already has a significant portion that doesn’t trust vaccines.
The Bad Side of Global Health Security
This convergence of public health and national security started about 20 years ago, when the security studies community discovered that pandemics did in fact have an impact on society. This was codified during the Bush administration in the 2004 “Biodefense for the 21st Century” presidential directive, which was primarily aimed at advances in biotechnology and the life science that might lead to new biological threats. That guidance also addressed the threat of “potentially infectious agents from beyond our borders” that would require “safe, effective medical countermeasures” developed by the Department of Health and Human Services. This national focus on countering biological threats, both deliberate and natural, continued through the Obama administration and into the Trump administration. This has perpetuated a long-term delay in modernizing non-medical chemical and biological defense equipment that the U.S. military sorely needs.
The U.S. public health community, on the other hand, has been very aware of the impact of natural disease outbreaks on society, having been working on this very issue for over a hundred years. Global health security may be new, but the impact of natural disease outbreaks on society and international relations certainly is not. There’s a very real difference in cultures between the security studies community and the public health community, in that the security studies community views crises like a dog views squirrels. When an infectious disease pops up in the United States, the national security community goes into full alert, moving to manage the crisis until the threat passes. Then it goes to sleep until the next health crisis emerges to threaten the homeland.
The public health community understands that, if one is serious about global health issues, one has to address the broader challenge of human security in which serious efforts to improve health systems would include building health infrastructure in poorer countries, reducing the prices of medical treatments and diagnostics, and addressing access to clean water, housing, and education. It’s a longer process, but it’s more effective than the security-sided “whack-a-mole” approach, in which the United States took actions only when a significant disease outbreak crossed U.S. borders. Just look at America’s record — SARS in 2002, pandemic influenza in 2009, Ebola in 2013, and now COVID-19. One would hope that there was a refined process in place by now, if in fact global health was considered a significant national security concern. Significant outbreaks of influenza, yellow fever, malaria, dengue fever, and cholera in Africa and Asia weren’t an issue to the extent that they didn’t get to America.
Today, the pharmaceutical firm Pfizer has made great strides working toward a COVID-19 vaccine. Working with a German company, BioNTech, it is ready to start human trials on four vaccine candidates and may have an approved vaccine by the end of the year. This is without the extensive U.S. government aid that is going to Operation Warp Speed. There are over 100 promising vaccine candidates being tested around the world. Oxford University has a potential candidate lined up for a fall release. Moderna Therapeutics and Kaiser Pharmaceutical are working with the Food and Drug Administration and Health and Human Services on fast-tracking their vaccine candidate. Why does the Department of Defense need to be leading a vaccine development project?
The popular view inside the national security community today is to ruminate on how COVID-19 will change national security priorities. The lesson isn’t that national security concerns should be broadened to include public health threats. It’s that the public health community should receive the resources and priorities required to advance global health goals, which will ultimately benefit the United States. Global health needs to be decoupled from global security, rather than deepening the connection, so as to ensure that long-term strategies take hold and address relevant health policy issues. This will require extensive engagement with the political process that rules all government efforts. Why not start with this crisis?
Al Mauroni is the director of the U.S. Air Force Center for Strategic Deterrence Studies and author of the book Countering Weapons of Mass Destruction: Assessing the U.S. Government’s Policy. The opinions, conclusions, and recommendations expressed or implied within are those of the author and do not necessarily reflect the views of the Air University, U.S. Air Force, or Department of Defense.