Operation Warp Speed brought together a broad array of government resources to achieve a similar, seemingly impossible rapid pace of development, regulatory approval, and distribution of vaccines to prevent COVID-19. But no matter how quickly or successfully vaccine(s) are developed we have been woefully ineffective in the development of other ways to tame the pandemic, especially readily available and accurate tests and proper PPE. Will the Biden plan pick up the slack?
"Warp Speed" is the impossibly fast fictional space travel that exceeds the speed of light, which was popularized by the Star Trek TV series and movies. The Trump administration's Operation Warp Speed (OWS) has brought together a broad array of government resources to achieve a similar, seemingly impossible rapid pace of development, regulatory approval, and distribution of vaccines to prevent COVID-19, the disease caused by the SARS-CoV-2 virus.
OWS hopes to see its first vaccine available in the U.S. for limited distribution around the end of this calendar year. This would be a remarkable accomplishment given the multiyear, or even decade-long development times for previous vaccines, and holds the promise of helping to control, if not actually eradicate, COVID-19.
OWS is fashioned after WWII's Manhattan Project, a massive government effort to exploit the potential of nuclear energy to develop an atomic bomb, the ultimate military weapon. The project is considered perhaps the greatest research and development success story in history.
A COVID-19 vaccine will be only one critical intervention to control the pandemic. Regrettably, numerous failures on other fronts have handicapped the response to COVID-19 and squandered time, health, and lives. On October 7th, citing data from the Johns Hopkins Center for Systems Science and Engineering, the New England Journal of Medicine editorialized:
. . . when the disease first arrived, we were incapable of testing effectively and couldn't provide even the most basic personal protective equipment to health care workers and the general public. And we continue to be way behind the curve in testing. While the absolute numbers of tests have increased substantially, the more useful metric is the number of tests performed per infected person, a rate that puts us far down the international list, below such places as Kazakhstan, Zimbabwe, and Ethiopia.
The administration erred by not including in Operation Warp Speed the development of tests and other non-vaccine essentials. The Biden coronavirus task force should make correcting those omissions a top priority.
Problems with testing to diagnose active infections in individuals and to ascertain the penetrance of COVID-19 in the population has been another failure in U.S. prevention and suppression efforts. Testing was delayed early in the year as the Centers for Disease Control and Prevention (CDC) distributed faulty test kits, then failed to approve a working test developed by the World Health Organization or those developed by local public health laboratories. This hampered rapid diagnosis and subsequent isolation, and contact tracing and kept us constantly behind the curve, unable to keep up with the tidal wave of infections.
In addition, the limitations of the tests and widespread misunderstanding of their purposes has resulted in various entities, from airports to the White House, using testing for screening people in the same manner as the use of a magnetometer to determine whether someone is carrying a prohibited metal item. But virus testing results do not provide a comparable level of real-time yes/no certainty.
Tests that detect the presence of the virus, its constituents, or disease correlates -- the polymerase chain reaction (PCR) test, the antigen test, and the antibody test, respectively -- offer unique benefits for diagnosis or population screening purposes. A major tradeoff has been between accuracy and speed. Results of the most accurate tests may take too long for effective disease management. Rapid tests have more false positives or negatives, but results are available in a matter of minutes. The antibody test is useful to determine who has had COVID-19 recently and mounted an immune response. However, the role of the government in developing, approving, and making these available has been a study in confusion and bumbling.
An OWS effort to refine these tests, make them widely available, and establish paradigms for their optimal use would go a long way toward slowing the spread of COVID-19. Without readily available, accurate tests for specific purposes, and timely results, effective prevention through contact tracing and isolation is impossible.
Another kind of testing that has proven valuable in the U.K. and that OWS neglected is the widespread sequencing of the viral genome, which can be used to rule in or rule out chains of transmission that may have occurred. If, for example four people who work in the same office are sick, but all have different sub-strains of the virus, that would suggest that the viral infections were brought into the office from outside, but did not spread within it. The office could, therefore, safely stay open.
A real-world example of the source of spread of infection being identified by sequencing occurred in the U.K. In six British dialysis patients with COVID-19, "sequencing revealed they had been infected by almost identical sub-strains of SARS-CoV-2." After it was determined that all six had visited the same outpatient dialysis clinic on the same day of the week and many had been transported in the same van, officials put in place new policies, including mandatory masks, intense cleaning of the van, and new procedures at the clinic.
Likewise, OWS should have overseen the development of important materiel such as personal protective equipment (PPE), which are inexpensive and highly effective. An effective facemask can help to prevent the spread of coronavirus by blocking droplets that are emitted when someone coughs, sneezes, talks, or breathes, but even this far into the pandemic, we have not gotten clear and useful guidance from federal officials or other sources about which masks (and other PPE) work best. "There's a lot of information out there, but it's confusing to put all the lines of evidence together," according to Columbia University virologist Angela Rasmussen. "When it comes down to it, we still don't know a lot."
The government sets standards for PPE of various kinds. For example, condoms are the most widely used PPE, which are also made available to some for free to encourage their use. Operation Warp Speed could have flooded the country with high-quality masks and other PPE of known effectiveness certified by the government or approved private-sector entities such as Underwriters Laboratories, using production mandates under the Defense Production Act, if necessary. Americans still need to know which masks work best for preventing transmission of the SARS-CoV-2 virus, and have them readily available.
OWS staffers should be constantly monitoring for new, highly promising approaches to preventing or treating SARS-CoV-2 infections. One example is a nasal spray that blocks the absorption of the SARS-CoV-2 virus and has conferred complete protection in recently reported experiments on ferrets. It contains a lipopeptide with a stretch of amino acids that is found in the virus's spike protein, which the virus uses to attach cell receptors in the airway or lung. The work was funded by the National Institutes of Health and the Columbia University Medical Center and, according to news reports, "would require additional funding to pursue clinical trials in humans." That sounds to us like a promising candidate for OWS attention.
The White House made an effort to address some of these issues in an August 6th Executive Order, which directed the FDA "to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms," including "diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment..." But in the absence of the leadership, technical focus, and authority that OWS could have brought to bear, little progress has been evident. Regrettably, we must agree with the NEJM editorial's observation that our leaders "have taken a crisis and turned it into a tragedy." It seems that the just-released Biden COVID-19 plan does intend to pursue some of the broad spectrum of measures necessary to blunt, if not end, the pandemic.
John J. Cohrssen is an attorney who has served in a number of government posts in the executive and legislative branches of the federal government, including counsel for the House Energy and Commerce Committee. Henry I. Miller, a physician, and molecular biologist was a Research Associate at the NIH and the founding director of the FDA's Office of Biotechnology.