Monday, October 12, 2020

What is—and should be—the military’s role in COVID-19 research?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

A recent STAT News report found that Operation Warp Speed—the government’s Manhattan Project-style effort to quickly develop a COVID-19 vaccine—has substantial military involvement. Although it might initially seem counterintuitive to think of the virus as a military issue, the military’s involvement is part of a long history of government military spending on public health aims. What has been the role of military involvement and spending on preventing and treating diseases with pandemic potential? What’s different, if anything, for COVID? And what should policymakers and scholars be focused on going forward?

What role has the military previously played in R&D for infectious diseases?

As emphasized in a 2017 National Academies report, “global health security is national security,” and an infectious disease pandemic poses a particularly serious risk. Despite many such warnings, the United States still severely underinvested in pandemic preparedness; for example, a September 2019 report requested by the World Bank and WHO described “insufficient R&D investment and planning” for vaccines, antivirals, nonpharmaceutical interventions, and related innovations. But the military played an important and often overlooked role in the investments that were made. Americans have long supported massive military spending to prepare for and prevent national security threats, and some of this funding has been used for R&D. Indeed, across all areas of technology, the Department of Defense (DOD) provides more R&D funding than any other single agency, and DOD medical and health research expenditures are higher than those of any agency other than NIH (see Table 4 here). 

The military has played an important role in fighting infectious diseases throughout U.S. history, particularly when these diseases have threatened U.S. servicemembers. George Washington’s Continental Army created the first organized program to prevent smallpox after half of the 10,000 soldiers around Quebec caught the disease in 1776. Widespread yellow fever among U.S. troops during the Spanish-American War of 1898 spurred the U.S. Army to study the disease, determining that mosquitoes were responsible for its spread and laying the groundwork for a vaccine. After WWII, a 1953 respiratory disease outbreak among Army troops led researchers at the Walter Reed Army Institute of Research to identify a new adenovirus family and to create a vaccine a record-breaking three years later, in 1956.

More recently, military researchers have helped develop candidate vaccines for HIV and malaria, in addition to helping with development and distribution of HIV and malaria treatments. As Professor Ana Santos Rutschman has documented, the military also has played an important role in the efforts to develop Ebola and Zika vaccines. 

These efforts occur across the service branches as well as through the Defense Advanced Research Projects Agency (DARPA). Of the 238 sponsored projects currently listed on DARPA’s website, 15 are disease related, including a project with five teams of researchers focused on targeting pathogens in animals before they jump to humans and a project to produce protective antibodies for first responders to halt any outbreak within 60 days. These moonshot plans may sound like science fiction for now, but DARPA has successfully spurred past breakthroughs ranging from technology that formed the basis of the Internet (ARPANET) to the use of graphical user interfaces. DARPA’s creativity is not limited to the high-risk projects it funds; it has also experimented with novel methods of providing innovation funding, such as the $500,000 prize fund offered for predicting chikungunya epidemics across the Americas for a six-month period.

What role does the military play for the development of COVID-19 vaccines and therapies?

The military has been highly involved in the government’s response to COVID-19, most remarkably in Operation Warp Speed. Roughly two-thirds of the OWS leadership are employed by the DOD (the rest are mostly from the Department of Health and Human Services (HHS)).

To date, the military’s role in OWS has been focused on logistics. As we have noted before, manufacturing and distributing vaccines at very large scale brings substantial challenges; military resources have been involved in distributing raw production materials and in stockpiling the resulting products. Cold-chain logistics are especially difficult; Pfizer’s vaccine, for instance, must be stored in special freezers that maintain a temperature -80ºC. This presents particular challenges to getting the vaccine from manufacturers to patients, requiring a cold chain (perhaps even a particularly complex one) and administering not one but perhaps two doses for several of the leading candidates. The Army Corps of Engineers has also been particularly involved in tackling these issues, including maintenance of freezers. Aside from aliquots of the vaccine itself, distributing a COVID-19 vaccine will require ensuring there are enough associated supplies (such as syringes) to vaccinate the vast majority of Americans. The military may be well-suited to manage these vast logistical challenges in a way that other administrative agencies are not—especially with the assistance of the United States Public Health Service Commissioned Corps.

And of course, the military is also doing what you’d expect the military to do: it is providing security, both physical and cyber, to therapeutic and vaccine developers and manufacturers. It might seem surprising that the makers of products to stop devastating global pandemic would be the target of cyberattacks—but they are. Hacking, cyberattacks, and ransomware, including on clinical trials, are all increasing.

For Operation Warp Speed, the military is not doing is the science itself. Paul Mango, the deputy chief of staff for policy at HHS, and high in the OWS organizational chart, stated that “we are not conducting any science whatsoever inside the government to support Operation Warp Speed, none.”

Finally, in addition to its role in therapeutic development, the military has also been involved in the caring and triage of COVID patients, most famously, perhaps, in New York State at the height of the state’s outbreak. There, the Army Corps of Engineers converted the Javits Convention Center into a 2,000-bed hospital and the USNS Comfort, a naval hospital ship, took overflow patients—though by the time the 1,000-bed sailed from New York, it had treated only 186 patients.

What should policymakers be attuned to about military involvement in public health projects like these?

As policymakers consider when and how the military ought to be involved in the development and distribution of health care technologies, both for COVID-19 and beyond, they should consider both the strengths and weaknesses of military involvement.

One of the strengths of the military for innovation comes from its use of procurement policy to drive novel research and development. As we have discussed previously, pull incentives that provide certainty about the expected reward for a newly developed technology can be important in encouraging the development of innovation in a particular technological area. In the COVID-19 context, the United States has entered into a number of advance purchase agreements for vaccine candidates with the result of promoting early investment in vaccine manufacturing, but in other contexts where the potential market for a product is less certain, procurement agreements may provide sufficient incentives to invest in a product that would otherwise not have been developed.

At the same time, there are also reasons to be skeptical about the military’s involvement in the distribution of public health interventions. Given the diversity of settings into which the military is likely to be deployed, the military is unlikely to understand community dynamics on the ground everywhere, and will need to partner with local organizations—local public health officials and community organizations of various types—to build the trust needed to achieve its goals. Americans generally have more confidence in the military than in other U.S. institutions, so military involvement may help some communities overcome vaccine skepticism. But trust in the military likely varies by community, and in light of abuses against minority groups in particular, in some communities military involvement may increase rather than decrease skepticism.

When policymakers consider how the military might helpfully be involved in the development and distribution of new health care technologies, they ought to consider how the military should coordinate and cooperate with other agencies in doing so. In 2017, the Government Accountability Office recommended that DOD, HHS, and the Department of Homeland Security ought to use their “existing coordination mechanisms to improve their pandemic preparedness.” These agencies do have ongoing collaborative efforts, for instance, as the FDA and DOD collaborate on the development and approval of medical products intended for use in military personnel. But in the same way that Operation Warp Speed aims to orchestrate this coordination with leadership at the White House level, existing initiatives could benefit from greater centralized review and management, of the type articulated by Professors Stuart Benjamin and Arti Rai in their work. And for some efforts, like distributing vaccines requiring a complex cold chain to hundreds of millions of Americans, centralized and effective leadership at the top may make all the difference.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post. 

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