The massive COVID-19 relief bill just passed by Congress provides $22.4 billion for "the necessary expenses for testing, contact tracing, surveillance, containment and mitigation to monitor and suppress COVID-19." The provision would fund tests for both active infection and prior exposure and bankroll the ramped up manufacture, procurement, and distribution of tests and testing equipment and supplies. The funds are supposed to be made available no later than 21 days after the bill becomes law. In addition, the appropriated monies are supposed to support the development of COVID-19 testing plans, however, the legislation does not outline how an effective COVID-19 testing regime should be set up and rolled out. So, what to do?
Since the early spectacular federal government failures with respect to developing and deploying COVID-19 tests at the beginning of the pandemic, the country has always been a step behind the proliferating coronavirus. It didn't have to be that way. At the end of April, the federal government launched its Rapid Acceleration of Diagnostics (RADx) initiative at the National Institutes of Health, funded with $1.5 billion. Contrast this budget with Operation Warp Speed's $18 billion budget to develop and deploy vaccines against COVID-19.
The RADx initiative, it must be acknowledged, has been successful in stimulating research and development on a remarkably wide variety of COVID-19 tests, including molecular, antigen, and serological tests. The Food and Drug Administration (FDA) brags that it has issued Emergency Use Authorizations (EUA) for 305 COVID-19 tests so far. However, 10 months after the first COVID-19 cases were detected in the U.S., none of the tests funded by RADx or approved by the FDA have been deployed on nearly the scale needed to blunt the course of the pandemic.
Still, the number of COVID-19 tests in the past week was just over 13 million, up from a few tens of thousands per week back in March. So if a couple of million tests per day is not enough to "monitor and suppress COVID-19," how many would be?
Harvard epidemiologist Michael Mina and his colleagues have been advocating for months now a plan to roll out community COVID-19 testing using rapid, cheap at-home antigen tests. COVID-19 antigen tests would have the convenience that at-home paper pregnancy and HIV tests provide. In a recent open letter to Congress signed by 50 leading infectious disease experts, Mina urged the federal government to spend "$500 million—$1 billion to jump-start upfront manufacturing capacity and $5 billion—$10 billion to implement nationwide rapid antigen testing for one year."
At a press conference in November, Mina estimated that it would take between 10 and 20 million tests per day to achieve vaccine-like herd immunity effects through halting the transmission of the virus through the population. As he noted in Time magazine, "Unlike vaccines, which stop onward transmission through immunity, testing can do this by giving people the tools to know, in real-time, that they are contagious and thus stop themselves from unknowingly spreading to others."
Such a strategy works. For example, as daily diagnosed COVID-19 cases were rising in the Eastern European country of Slovakia, its government initiated a nationwide campaign in which 3.6 million of its 5.5 million citizens were tested using a South Korean point-of-care antigen test over the first weekend in November for COVID-19 infections. Those who tested positive isolated themselves so as to not transmit the virus to others. Subsequently, daily COVID-19 infections fell by 60 percent in that country. Thereafter, the government moved quickly to ease COVID-19 curbs and testing fell off in November. Diagnosed cases subsequently began rising in December. Now the country is once again increasing its daily number of tests.
Washington Post columnist Megan McCardle explained in a thought experiment how testing can spare millions of Americans from the disease. Start with 100,000 pre-symptomatic and asymptomatic infected people who will, on average, infect three other people. If that 100,000 had taken advantage of a COVID-19 test that detects only 90 percent of infections, that would still catch 90,000 cases. Being responsible individuals who do not want to risk infecting other non-consenting people, the 90,000 with detected infections would then voluntarily isolate themselves. So instead of 300,000 new infections, the 10,000 undetected folks transmit the virus to only 30,000 other people. In the next round of testing, the 3,000 undetected cases transmit to just 9,000 other people. And so forth until the epidemic is essentially crushed.
As it happens, the FDA finally got around on December 15 to approving an at-home over-the-counter antigen test from the Australian company Ellume that provides results in 15 to 20 minutes. The company expects to provide 3 million at-home tests in January and deliver 20 million tests to the U.S. within the first half of 2021. A day later, the agency issued an EUA for the Abbott Laboratories at-home BinaxNOW antigen test. However, the FDA limits the test only to symptomatic people, requires a prescription for it, and taking it must be supervised by online telehealth experts. As a result, BinaxNOW is not a fast, cheap at-home test that could be widely deployed for community-scale testing. The open letter basically begs the FDA to stop over-regulating rapid antigen tests aimed at community testing by treating them like they are medical tests for diagnosing individual patients.
The open letter from Mina and his colleagues concludes:
Over the next six months, it is our profound hope that the vaccination of the majority of Americans may bring substantial relief from COVID-19. Until then, widespread and frequent rapid antigen testing is one of the best available public health tools at our disposal today.
Antigen tests can detect contagious people early in the disease, before symptoms develop. Used appropriately, these tests could curb outbreaks of the virus by reducing transmission. They provide a critical layer of protection to supplement masks, social distancing, and other precautions. They can help bridge the gap until broad vaccination is achieved.
The hopeful news is that despite federal government's manifold failures in this arena the Rockefeller Foundation estimates in a recent report that by the end of January, the country will likely be able to conduct more than 70 million tests each week, rising to 200 million by April. In other words, we may finally be getting close to Mina's threshold for throttling back the pandemic. Is it too much to hope that, in its remaining time, the Trump administration will seek to build on its amazing Operation Warp Speed vaccine successes by directing $10 billion or so of the COVID-19 relief funds to making tens of millions of cheap rapid antigen tests available daily to Americans?