We are living in an age of epidemics. Even before Covid-19, the frequency and severity of infectious disease outbreaks had been increasing. Since 2000, we have seen SARS, H1N1 flu, MERS, Ebola, and Zika outbreaks. The recent discovery in China of a new strain of “swine flu” reminds us that novel strains of influenza continually emerge in animals, sporadically infect humans, and are just a few mutations away from becoming the next pandemic.
Most Americans are rightly focused on getting through a pandemic that is far from over. But we must seize this moment and begin work to improve our nation’s capabilities for dealing with future—and potentially worse—epidemics. Our nation’s failures in fighting Covid-19 can serve as a map to a better response.
Since the Amerithrax letter attacks in 2001, the U.S. government has spent billions on biodefense. This funding has been primarily directed toward measures targeting man-made biological threats, such as anthrax and smallpox. The threat of a deliberate biological attack deserves our continued attention. But Covid-19 has painfully highlighted that we have been neglecting key capabilities for combatting all types of infectious disease outbreaks, whether deliberate or naturally emerging.
Going forward, we must focus on key elements that are absolutely required to contain outbreaks before they become pandemics. Outbreaks are inevitable, pandemics are not.
Historically, the Centers for Disease Control and Prevention has taken on the role of developing diagnostic tests and distributing them to public-health laboratories at the outset of an epidemic. Covid-19 exposed the shortcomings of this framework: Relying solely on the CDC majorly backfired when its test proved faulty. Without an alternative supply of diagnostic tests, the epidemic was allowed to spread undetected.
Even if the CDC had rolled out an effective test, it cannot scale up test production to meet the needs of a major outbreak. In contrast, the laboratory company Quest Diagnostics is now conducting more than 200,000 tests per day for active Covid-19 infections, illustrating that the best testing system is the one used by patients and doctors during normal times.
It is essential to engage private test developers from day 1. They have the tools, the latest innovations, can operate at scale, and are already well-integrated into the health-care system. Private developers will engage if it makes economic sense. They need the federal government to provide a clear reimbursement scheme, material assistance for test validation, a reliable supply chain of materials, and a clear and expedited regulatory pathway.
Covid-19 spurred some innovation on the fly that should become standard. For example, the Centers for Medicare and Medicaid Services nearly doubled payment for certain high-throughput Covid-19 diagnostic lab tests. However, access to virus samples and other materials for test validation and production are a recurring problem for diagnostic developers. The Department of Health and Human Services needs to establish a service to help developers access samples and other materials required for efficient test validation and production.
We need to go further and create market incentives to promote diagnostics that are truly disruptive. Imagine cheap, daily-use paper tests that allow individuals to spit into a tube and get a Covid-19 test result in 15 minutes. The tests should also have embedded technologies to submit information directly to public-health officials. The patient would know whether to go to work or self-isolate, and officials could better track the outbreak.
Contact tracing, the public-health version of detective work, has never been done at the speed or scale needed for a highly transmissible respiratory disease like Covid-19. Most states are failing miserably to execute it. Meeting this challenge will require new technology and additional manpower.
Technology to support contact tracing efforts was deployed in several countries, such as Singapore and Australia. In the United States, efforts are stalling, partly due to concerns that contact tracing technologies may violate civil liberties. We can develop contact tracing technologies that protect privacy and comport with our values, but it will require federal leadership to drive implementation working alongside technology companies, the public-health community, and civil society.
The shutdown is a chain saw, a brute instrument to rapidly force people to physically distance to avert a catastrophic failure of the health-care system. As we are seeing now going into a new cycle of shutdowns in many states, the short-term public-health gains are not sustained once cities reopen, but the social and economic impacts are long-lasting. By September, research suggests some students will have lost a year’s worth of education.
We need to figure out how to do physical distancing with a scalpel, to maximize its impact on slowing disease transmission while minimizing societal disruption. Technology can help. Much like we can check the weather on our phones before deciding whether to carry an umbrella, we may one day check an app before deciding whether to wear a mask or even to go out at all. Likewise, decisions about opening or closing businesses, schools, and crowded events should be guided by near real-time data about the prevalence of disease in a given locality.
Covid-19 showed how many of the facets of treatment are broken in the U.S.
The world looked in shock as American health-care workers pleaded for personal protective equipment to do their jobs with a modicum of safety. The PPE supply chain needs to be fixed. Some critical components may have to be re-shored for domestic production. The distribution of limited PPE resources needs to be guided by the best logistics technology.
At the onset of an epidemic, the first treatments tested are those already approved for other indications; we need to promote technologies that can help identify promising preapproved drugs. For example, the artificial intelligence startup Benevolent AI discovered that an arthritis drug, an Eli Lilly biologic known as baricitinib, might be effective against Covid-19. That finding spurred a clinical trial that is continuing.
We must modernize our clinical-trials infrastructure to provide definitive answers on safety and efficacy of new drugs quickly. The most efficient approach is to embed randomized clinical trials (the gold standard) within the routine delivery of care in large health-care systems.
The U.K. has done that. It launched an ambitious but pragmatic randomized clinical trial that leverages data from the National Health Service system. Within a few weeks, the trial established that hydroxychloroquine doesn’t work but that dexamethasone does improve survival of certain Covid-19 patients. The U.S. is repurposing existing clinical-trial networks for diseases such as HIV to study Covid-19 treatments, but the process is much slower than the U.K.’s.
The U.S. government’s Operation Warp Speed has the goal of producing 300 million doses of a Covid-19 vaccine by January 2021. It’s worth applauding. This would be enough vaccines for most Americans, just one year after release of the novel coronavirus genetic sequence.
But for the next pandemic, “warp speed” for a vaccine needs to be faster than a year. We should continue to invest in platform technologies for the rapid design of vaccines. For example, Moderna’s innovative mRNA platform enabled it to quickly design a vaccine and initiate a clinical trial for its Covid-19 vaccine candidate. But vaccine development fails at a high rate. We need an arsenal of vaccine platforms to increase the chances of viable candidates for an emerging outbreak.
We also need to ramp up investments in vaccine manufacturing technology to quickly scale up production. It turns out that the rate-limiting step for having an ample supply of vaccine is likely neither vaccine design nor testing in clinical trials, but scaling up manufacturing processes. Operation Warp Speed is looking for facilities to augment manufacturing capacity for Covid-19 vaccines, but investing in innovative vaccine manufacturing technology for faster production will be essential in the future.
Metrics are powerful influencers. For far too long, our government has measured success in biodefense by how many vaccines, therapeutics, and other medical countermeasures are placed in the Strategic National Stockpile. Many of these countermeasures are geared toward just a handful of threats, like anthrax and smallpox. Covid-19 has shown the limitations of the “one bug, one drug” focus in the age of epidemics. These metrics were easy to tally up in the SNS, but didn’t provide us with the needed capabilities for Covid-19.
In the age of epidemics, speed and flexibility are paramount. The right metrics will assess our ability to test, trace, physically distance, treat, and vaccinate against a rapidly emerging infectious disease with many unknowns. And we will never meet these ambitious goals without better integration of the private sector and improved technology. We need to quickly manufacture, at scale, diagnostic tests that provide rapid readouts. We need to contact trace at an unprecedented pace. We need advances in data gathering and analysis, along with user-friendly apps, to enable a more flexible approach to physical distancing. We need to use artificial intelligence and other technology to effectively repurpose existing drugs and a modernized infrastructure to rapidly evaluate them in people. We need vaccine manufacturing technologies that allow us to scale up to 300 million doses within weeks, not months.
Metrics for these capabilities can be tough to quantify, but they offer the truest road map for what’s needed to combat the next potential pandemic. We will be tested again, and next time we must do better.
Luciana Borio is a vice president at In-Q-Tel and was director for medical and biodefense preparedness policy at the National Security Council, 2017-19. Joseph Buccina is a director at In-Q-Tel’s B.Next, a strategic initiative focused on biotechnology and national security.