EXCLUSIVE

The Biden Administration Rejected an October Proposal for “Free Rapid Tests for the Holidays”

With omicron cases spreading like wildfire, the White House is finally taking steps to make free antigen tests available to all. But this fall, Vanity Fair has learned, it dismissed a bold plan to ramp up rapid testing ahead of the holidays. Frustrated experts explain how confusion, distrust, and a single-minded fixation on vaccinating Americans left testing on the back burner for so long.
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Photo Illustration by Vanity Fair, Photograph from Getty Images.

On October 22, a group of COVID-19 testing experts joined a Zoom call with officials from the Biden administration and presented a strategy for overhauling America’s approach to testing.

The 10-page plan, which Vanity Fair has obtained, would enable the U.S. to finally do what many other countries had already done: Put rapid at-home COVID-19 testing into the hands of average citizens, allowing them to screen themselves in real time and thereby help reduce transmission. The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide “Testing Surge to Prevent Holiday COVID Surge.”

The antigen tests at the center of the plan can detect the virus when patients are at their most contagious. Though less sensitive than polymerase chain reaction (PCR) laboratory tests, which can detect the virus’s genetic material at any stage of infection, antigen tests provide a quick snapshot in time for those seeking assurance that they are safe to travel or won’t accidentally infect vulnerable relatives.

The plan, in effect, was a blueprint for how to avoid what is happening at this very moment—endless lines of desperate Americans clamoring for tests in order to safeguard holiday gatherings, just as COVID-19 is exploding again. Yesterday, President Biden told David Muir of ABC News, “I wish I had thought about ordering” 500 million at-home tests “two months ago.” But the proposal shared at the meeting in October, disclosed here for the first time, included a “Bold Plan for Impact” and a provision for “Every American Household to Receive Free Rapid Tests for the Holidays/New Year.”

The first page of the testing plan presented at the White House in October 2021. Click here to view the remaining pages.

Three days after the meeting, on October 25, the COVID-19 testing experts—who hailed from the Harvard T.H. Chan School of Public Health, the Rockefeller Foundation, the COVID Collaborative, and several other organizations—received a back channel communication from a White House official. Their big, bold idea for free home tests for all Americans to avoid a holiday surge, they were told, was dead. That day, the administration instead announced an initiative to move rapid home tests more swiftly through the FDA’s regulatory approval process.

The meeting attendees came away with mixed opinions. “The White House, in baseball terms, was playing small ball,” said Dr. Steven Phillips, a vice president of science and strategy for the Covid Collaborative, a team of high-level experts working to develop consensus recommendations for policy makers. “When it comes to rapid testing, they’re bunting the players along.” But Andrew Sweet, managing director of COVID-19 response and recovery at the Rockefeller Foundation, found the White House “responsive” and believes the meeting laid the groundwork for future announcements.

An administration official who attended the meeting told Vanity Fair that, while everyone present shared the same goal of expanding rapid testing as soon as possible, the plan could not be implemented at that time: “We did not have capacity to manufacture over-the-counter tests at that scale.” The problem, in essence, was twofold: The FDA had authorized only a handful of different home tests, and those it had authorized could not increase manufacturing fast enough.

On December 2, with omicron threatening an imminent wave of new infections, Biden announced a smattering of smaller-scale plans that included requiring insurance companies to reimburse privately insured patients who buy at-home rapid tests, which sell for as much as $35 for a box of two tests—if you can find them amid widespread shortages. Four days after that, White House press secretary Jen Psaki seemed to deride the very idea of free nationwide home tests. “Should we just send one to every American?” she mused sarcastically from the briefing room podium. “Then what happens if you—if every American has one test? How much does that cost, and then what happens after that?”

A page from the testing plan presented at the White House in October 2021. Click here to view the remaining pages.

The fury with which public-health experts greeted Psaki’s comments reflected their longstanding frustration with an administration that, in their view, has put almost all its focus on vaccinating the American public, at the expense of other critical aspects of the response, from getting shots into arms overseas to making high-quality masks widely available. The rapid-test push, in particular, seems to have bumped up against the peculiar challenges of fighting COVID-19 in the 21st-century United States. Difficulties include a regulatory gauntlet intent on vetting devices for exquisite sensitivity, rather than public-health utility; a medical fiefdom in which doctors tend to view patient test results as theirs alone to convey; and a policy suspicion, however inchoate, that too many rapid tests might somehow signal to wary Americans that they could test their way through the pandemic and skip vaccinations altogether. “It’s undeniable that [the administration] took a vaccine-only approach,” said Dr. Michael Mina, a vocal advocate for rapid testing who attended the October White House meeting. The U.S. government “didn’t support the notion of testing as a proper mitigation tool.”

On Tuesday, faced with a terrifying omicron surge, a stampede of holiday travel, and images of Americans waiting in hours-long testing lines from Brooklyn to Miami, Biden finally announced that his administration would do what many experts had been urging since the earliest days of the COVID-19 pandemic: Give Americans the ability to diagnose themselves. The federal government will launch a website next month where individuals can request free rapid tests that will be mailed to their homes. That plan requires 500 million test kits that the administration has yet to procure.

“The administration has been focused on expanding testing since the very beginning,” Dr. Tom Inglesby, who in January will become senior adviser for testing on the White House COVID-19 response team, told Vanity Fair. “It has always been a major pillar of the approach.” When Biden took office, there were no rapid, at-home COVID tests on the market; there are now 13. And the monthly supply has almost quadrupled since late summer. The administration has invested more than $23 billion on expanding testing, surging manufacturing capacity, and improving genomic sequencing, according to Mara Aspinall, cofounder of the biomedical diagnostics program at Arizona State University.

But the president’s announcement on Tuesday struck many experts as “an exemplar of too little, too late,” as Dr. Eric Topol, director and founder of the Scripps Research Translational Institute in La Jolla, California, put it in a Substack post on Tuesday. Topol called the plan to make 500 million free rapid tests available sometime next year “totally inadequate,” writing, “We need several billion of these, and have needed them for over a year to help prevent spread, as validated and relied upon in many countries throughout the world.”

Critics say the Biden administration has been slow to act on testing, in part because it saw vaccination as the best pathway out of the pandemic. The Centers for Disease Control and Prevention assured Americans early this summer that, once vaccinated, they could shed their masks and forgo testing. Those declarations quickly proved untrue as breakthrough infections have risen. “We put all our eggs in the vaccine basket and it’s not enough,” Dr. Jay Wohlgemuth, chief medical officer at Quest Diagnostics, told Vanity Fair.

Three experts who interacted with the White House came to believe that the Biden administration had deprioritized rapid testing, partly out of concern that people would opt for that instead of getting vaccinated. As one expert put it, “It was clear they felt that people who didn’t want to get vaccinated might like no-strings-attached rapid testing.” The White House’s Tom Inglesby said the administration was always committed to both: “In our analysis, they are not competing with each other. They are not zero sum.”

It has fallen to a small but determined group of advocates to argue that rapid testing is an essential strategic tool, and should be pursued as aggressively as vaccinations. Chief among them is Dr. Michael Mina, who until recently worked as an assistant professor of epidemiology and immunology and infectious diseases at the Harvard T. H. Chan School of Public Health, and as an associate medical director of molecular virology diagnostics at the Brigham and Women’s Hospital. He is now chief science officer at a Miami-based diagnostic company, eMed.

His journey began as early as January 2020, when he saw clearly that Boston was going to need COVID tests it didn’t have. He sought funding from Brigham and Women’s Hospital to build a test. “They thought it was a joke,” he said of some of the hospital’s pathology officials.

So he went to the Broad Institute, got approval to use its sequencing platform, and helped establish what became a prodigious testing laboratory there. From the Broad, he went back to top Boston hospitals, including Brigham and Women’s, Tufts Medical Center, and Beth Israel Deaconess Medical Center, to offer the Broad’s new testing capacity as an additional resource. “The pushback I got was amazing and swift,” he said. There were “pissing contests everywhere,” as the physicians worked to protect their turf running hospital-based tests.

Once Mina began to advocate for rapid home tests, he encountered the same mindset: doctors “trying to guard their domain.” Some doctors had long opposed home testing, even for pregnancy and HIV, arguing that patients who learned on their own about a given condition would not be able to act on the information effectively. Testing, in this view, should be used only by doctors as a diagnostic instrument, not by individuals as a public-health tool for influencing decisions.

A similar view prevailed within the FDA. The agency had approved PCR tests with perfect sensitivity that could tell people for certain whether they were infected with SARS-CoV-2. Those tests, while crucial, were expensive, hard to access, and tended to take days to yield results, meaning that they had little mitigating effect on spread. By contrast, low-cost antigen tests, which patients could administer themselves at home, were less sensitive. And sensitivity is what mattered inside the agency. As one FDA medical device reviewer told Vanity Fair, “We review data. If the data we’re presented with aren’t great, we’re not going to want the public to use that device.”

Mina understood that mentality. That’s why he told the Biden-Harris transition team in late 2020 that the FDA should have a separate, streamlined pathway to approve devices—such as less sensitive at-home tests—that are crucial to public health. “We had rapid tests last summer and fall, but the FDA wouldn’t authorize them,” said Mina. “But they were completely fine with PCR tests giving back results seven days later.” Ultra-accurate tests that take a long time to process have a clinical benefit for treating patients, but they are of no help in deciding if you should go to work or get on a plane that day. “If our goal is defined as public health, every test run last year was practically useless.”

Speaking for the administration, Inglesby said of Mina’s idea, “There is a strong scientific consensus in the administration that there should not be a second, lower public health standard for some tests. Not only would this be confusing, but members of the public will use these tests to make very serious decisions for themselves and their families and so they need to meet the same standard.”

Doctors and regulators weren’t the only ones with qualms about rapid tests, which have been generally viewed as unreliable thanks to shaky reviews, bad press over recalls, and widespread confusion over what they can and cannot measure. One study found that the popular Binax Now test was 87% accurate in symptomatic cases and only 71% accurate in asymptomatic cases. According to Mina, however, the tests are “extremely sensitive for very contagious people. When you’re at peak viral load, these tests approach 100 percent sensitivity.”

Many Americans also recall that the Trump White House relied heavily on rapid tests in order to avoid canceling events or making them virtual, only to wind up swarmed with COVID cases. Only later did it turn out that Trump himself had ignored a positive test result and may well have sparked a September 2020 superspreader event in the Rose Garden himself. “That Rose Garden event created so much uncertainty around rapid tests,” says Mina. “It was the worst publicity.” But lost in the uproar was the fact that “the Trump administration tested every day before work and managed to go a full six months without having outbreaks,” he says. “No reporter ever writes about the outbreak that doesn’t happen. It’s not interesting.”

To address the misconception that rapid tests are all but uselessly inaccurate, Mina developed a chart that has made the rounds on social media. It shows that while a PCR test will detect an infection for many more days, rapid tests specifically indicate whether you are actively contagious at the time—a status that can change quickly, which is why it’s necessary to test often if you want to avoid infecting your grandmother at the Christmas party.

As the FDA lumbered along, rejecting antigen tests that inevitably failed to compete for accuracy with PCR tests, rapid home tests became ubiquitous in Europe. Private industry had leapt into the antigen home-testing market, with European governments from Germany to the United Kingdom becoming its biggest customers. “In Germany, you could take one [free] test a week,” said Peer Schatz, managing director of PS Capital Management, a venture fund for clinical diagnostics. “The U.K. was even more liberal. They flooded the market with these tests.”

With roughly 200 different home tests approved in Europe, the price is as low as $1.50 a test, said Schatz. “You go to offices and meetings, you see these tests lying around. It’s a free giveaway, like masks.” Schatz says the prevalence of home tests reflects a different mindset: “I really like the aggressive use of testing and the acceptance of this being a key pandemic tool and embracing the value of information, which tests provide, and accepting some of the weakness.” By contrast, some of the biggest testing companies, from Siemens to Roche, have not had rapid tests authorized by the FDA yet.

The U.S. is not the only country facing a shortage of rapid tests, as omicron sweeps the globe. This month, the British government ran out of rapid tests that it distributed through an official website. In Spain, pharmacy shelves were empty of rapid tests, after demand rose 500 percent in November. In Canada, after provincial governments vowed to distribute millions of rapid tests at pop-up sites, many citizens seeking them went away empty-handed

Once the Biden administration came into office, Mina, like many experts, saw an opportunity to transform the nation’s testing infrastructure.

In January, Mina and Dr. Steven Phillips of the COVID Collaborative sent the new administration a 23-page document outlining a national rapid-testing strategy that they argued would enable the country to reopen safely even before the vaccine rollout was complete. It made a case for rapid testing as the most powerful tool to reduce transmission and case counts quickly. But the Biden administration, said Phillips, lacked “the imagination to have an Operation Warp Speed-level program for testing.”

So far, the FDA has authorized only 13 rapid antigen tests. It has also authorized three at-home molecular tests, which have a sensitivity closer to that of a laboratory PCR test.

One of those molecular tests, Detect, was developed with an $8 million grant from the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative. Authorized by the FDA on October 28, it was invented by Dr. Jonathan Rothberg, who set out back in March 2020 to make an affordable at-home COVID test that could detect the virus’s genetic code. The idea was to take a “$25,000 technology and put it into a $50 design,” said Owen Kaye-Kauderer, Detect’s cofounder and chief business officer.

The challenges were immense. The supply chain was so constrained that the start-up had to control all its materials, down to making its own swabs. It also had to raise $110 million without regulatory approval. But Rothberg had a considerable track record. Awarded the National Medal of Technology and Innovation by President Obama in 2016, he invented the Ion Torrent Next Generation sequencing technology, and the machine on which it runs, which was used in South Africa to first detect and sequence the omicron variant.

To design the at-home test, the Detect team analyzed 2 million separate sequences of the COVID-19 virus and conducted preclinical studies throughout Guilford, Connecticut, where the company is headquartered, testing more than 9,000 townspeople, including firefighters and police officers.

The resulting Detect test is 1,500 times more sensitive than a typical rapid antigen test. “When you get a positive on our tests,” says Rothberg, “you have COVID.”

The starter kit, which comes with the Detect hub and a single test, sells for $75, and additional tests cost $49 each. They went on sale December 15 and swiftly sold out. “Within minutes, we had to limit” the number of tests per order, said Rothberg. “We don’t want any stockpiled. We want people to use it.” The team hopes to get the cost down to roughly $20 per test.

Rothberg and his team view the Detect test as one in an array of tests necessary to end the pandemic. “If you are trying to get 30,000 people into a stadium, rapid antigen tests are great,” said Kaye-Kauderer.

If Detect is part of a promising future, it feels all too distant from the reality today, when many Americans would be glad to get their hands on any test at all. Still, Mina sees the administration’s long-awaited U-turn as a hopeful sign. “Omicron pushed them over the edge,” he said. “We have to admit at every level of government that vaccines are not the end of this.”

Primary Source: the ten-page document presented at the White House in October 2021. Click here to enlarge the full PDF.

Christina Silcox, Ph.D.
Christina Silcox, Ph.D.
Christina Silcox, Ph.D.
Christina Silcox, Ph.D.
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