Biden vowed to fix testing. But he didn’t plan for Omicron.

By Kevin Liptak and Jeremy Diamond, CNN

As President Joe Biden was spending his holidays with family at the White House and in Delaware, he was frustrated to see images on television of Americans waiting in long lines for Covid-19 tests.

Nearly a year after he had taken office, the stubborn problem he had vowed to solve persisted, exposing a testing system that was failing once again to meet demand — and Biden’s own promises.

Anger over testing shortages has been mounting across the country — including inside the White House — since early December, when the Omicron variant began spreading widely across the country and the demand for tests began far outstripping the supply in many areas. According to people involved in the conversations, Biden himself has privately told top staff members in strong terms that he regrets that he and his team did not anticipate the shortfalls earlier, something he’s also made clear in public.

Despite those regrets, experts had been warning for months that testing capacity wasn’t where it should be as the holiday season approached, including during a virtual meeting with White House officials in October. Multiple experts argue that Biden and his team did not move quickly enough to address the coming shortfalls, and by then it was too late to dramatically increase supplies to levels that would have eased the current shortages.

“Everybody saw it coming. We knew we needed more tests,” Dr. Ashish Jha, dean of the Brown University School of Public Health, said on CNN last month. “I think the administration had dropped the ball on this.”

While Biden entered office with a plan to expand testing — pouring in billions of dollars to boost manufacturing and ramp up testing in schools — his top priority was vaccines, which kept most people out of the hospital and even slashed the chances of getting infected with and spreading the virus.

But vaccine hesitancy remains stubbornly high, and a new, highly transmissible variant that sidesteps much of the vaccines’ protection against infection has spread across the country, driving case counts to their highest levels to date. By December, it was evident Biden was falling short of the promise he had made as a candidate that “anyone who wants a test should be able to get one, period.”

That has prompted a hurried effort inside the White House to stand up a new test distribution program that officials say will provide free at-home rapid tests to any American who orders them online. Federal testing sites have opened in cities across the country and a new requirement for health insurance companies to reimburse for the cost of tests takes effect this week.

The White House says a slew of investments it made in the fall — including through the Defense Production Act — and efforts to speed up the authorization of new rapid tests have helped to dramatically increase the number of at-home tests. The monthly supply of at-home tests has risen from 25 million to 28 million in August to 46 million in October to 300 million today. The White House projects that next month the monthly supply will hit 350 million to 400 million, according to a White House memo obtained by CNN. Still, many experts say that even those ramped-up numbers are not enough.

“We’re not going to stop there. Those numbers will keep going up in the months ahead,” Dr. Tom Inglesby, the White House’s newly installed testing coordinator, said in an interview this week.

As the country shifts into a new phase of the pandemic focused less on eradicating Covid and more on learning to live with it, there is a renewed emphasis on the availability of testing to assure people they’re safe to travel and engage in other normal activities.

It’s a pivotal moment for the Biden White House. Aides to the President know he and his party will be judged by how well they navigate a return to “normal.” Pivoting quickly to improve testing supplies is a test of Biden’s ability to shift the country into a new stage of a virus he’s acknowledged is unlikely to completely disappear.

“What we’ve been hampered by is thinking that the role of testing is sort of secondary and optional, where really the role of testing is foundational throughout the course of the pandemic and throughout the exit from the pandemic,” said Dr. Thomas Tsai, assistant professor of health policy at Harvard T.H. Chan School of Public Health. “Because the testing is the information, is the early warning system, on whether cases are rising or decreasing. It’s the information that informs behavior.”

“We’ve always been chasing our tails within testing strategy,” Tsai added. “It’s never sort of coincided where we’ve had the demand and supply of tests … before the waves peak, so we can actually alter the course of the pandemic. It’s always documented the course of pandemic, as opposed to altering the course.”

An October warning

Two months before Christmas, medical experts foresaw a frantic last-minute shopping surge, with millions of Americans flooding stores in search of at-home Covid testing kits to tell them their holiday gatherings were safe. A group of doctors shared that vision with the White House at a meeting on October 22, urging officials to expand the nation’s testing capacity in a hurry.

The participants say they got what they wanted: “Massive efforts” to expand production and distribution of tests, as one of those physicians described it to CNN.

Yet it turned out the warning and the effort came too late. By that point, the doctors’ vision of 732 million tests per month by March 2022 was simply impossible to pull off. Demand for the tests had tumbled so low during the summer that manufacturers had dramatically reduced production. And at that point, only a handful of at-home tests were available for purchase.

“I think the bold initiative, had it come to fruition, would have been amazing,” said Dr. Michael Mina, a physician who was part of that October briefing with the Biden administration. “But it would have been very, very difficult in the last two months.”

Inglesby, who joined the White House this month as the Covid-19 Response Team testing coordinator, said the goals presented in the meeting were “ambitious” but impossible to reach in October because of the limited number of authorized over-the-counter tests.

“We all wish it could have been sooner if it were feasible. Everyone would have liked it to be earlier,” he said in an interview this week.

Inglesby noted that the testing shortage is not unique to the US: “If you look at newspapers all over the world, every country is having challenges meeting demand.”

Administration officials have been working behind the scenes for weeks in a hurried effort to stand up the free test program, including working with test manufacturers to solicit proposals and with website programmers to develop the portal where Americans will be able to request the tests.

Contracts between private companies and the federal government to procure the 500 million tests began being awarded on Friday, and more information about the website is expected in the coming days. The White House said it expected the first free rapid tests to be delivered to the government “early next week.”

White House officials insist the steps Biden took over the past months have made it possible to order the 500 million tests at all, including purchasing $3 billion in rapid tests during the late summer and early fall to bolster the market and spending another $1 billion to secure key supplies for test-makers using the Defense Production Act. They say those steps increased capacity when demand was low. But they have acknowledged it wasn’t enough to avert the Omicron-induced shortage.

“We do not have the tests that we need to meet all the demand,” Inglesby said of the current state of play, echoing a blunt acknowledgment from the President.

“Creating a system that can scale 50 to 60 times is challenging. We are working to meet that challenge, but it’s just really important to understand that this virus that we are working against now — this strain of virus — is moving and has accelerated in a way that was very different even from Delta and certainly from the world before Delta,” Inglesby said. “We have all the levers pulled.”

Too late to help?

Testing companies are poised to make the most of the moment. Manufacturers whose tests have been authorized by the US Food and Drug Administration — including Abbott, ACON and iHealth — had been increasing their capacity already and there have been significant changes in capacity for the start of 2022.

“It has taken a year and a half for the US to embrace the important role of rapid testing,” said a spokesperson for Abbott, who said the company was producing 70 million of its BinaxNOW products in January and prepared to “scale significantly further” in the coming months.

“It is important for the US to maintain the testing manufacturing capacity and supply during periods of low demand so we can respond to future variants and surges. We’re on the right path now, but we can’t be complacent or think that testing won’t play a critical role in our ability to gather safely later on.”

Yet even if tests begin reaching Americans by the end of January, that would be more than a month after the latest wave began hitting communities and the testing shortfalls became apparent.

Some in Congress have sharpened their criticism of the administration’s testing approach in recent weeks. In a letter last week addressed to US Health and Human Services Secretary Xavier Becerra, two senior Republicans on key health committees demanded answers on the Biden administration’s “lack of strategy” for Covid-19 testing.

“With over $82.6 billion specifically appropriated for testing, and flexibility within the Department to allocate additional funds from COVID-19 supplemental bills or annual appropriations if necessary, it is unclear to us why we are facing such dire circumstances now,” wrote Sens. Roy Blunt of Missouri and Richard Burr of North Carolina.

On Monday, a group of 50 lawmakers who included some high-profile Biden allies — such as Democratic Sens. Elizabeth Warren of Massachusetts and Amy Klobuchar of Minnesota, along with independent Sen. Bernie Sanders of Vermont — wrote a letter to the President urging “additional, immediate steps” to ramp up testing supply so that every American has access to one rapid test a week.

Officials say the scarcity of at-home tests this month was driven by a steep uptick in demand, particularly in major cities where cases began surging at the same moment Americans were entering the holiday stretch. Increased travel and family get-togethers prompted fresh interest in getting tested, which depleted stocks of at-home tests at drugstores and online.

The plan Biden announced in December to procure and distribute hundreds of millions of at-home rapid tests developed quickly over a stretch of days that month as reports emerged of empty shelves and sold-out notices, according to officials familiar with the matter.

Still, when Biden made that announcement, several details of the plan remained unresolved. Administration officials were unable to provide any specific details about when the website to request the tests would launch or how quickly tests would be shipped, pointing only to a broad timeline of early January. They also did not detail a plan to get tests to those with limited internet access.

A problem Biden promised to solve, but hasn’t

A buildup of factors over the past two years led to a shortfall in testing that became apparent only as the Omicron variant began spreading across the country in the weeks after Thanksgiving, according to administration officials and others familiar with the matter.

Since the beginning of the pandemic, testing has been an issue in the US pandemic response, many public health experts say.

The first tests developed in the United States by the US Centers for Disease Control and Prevention in early 2020 were faulty, keeping many local officials in the dark about the sizes of their outbreaks. Correcting these tests took nearly a month, leaving the country in a blind spot about how to contain the growing pandemic. There also were questions over who should be tested — only those who had symptoms, or close contacts of people with confirmed infections as well.

Biden entered office vowing to remedy the testing issues that had plagued the previous administration, and he signed an executive order on his first day in office meant to expand the availability of testing, including in schools and other “priority populations.”

He established a Pandemic Testing Board — a campaign promise modeled on President Franklin D. Roosevelt’s War Production Board — early in his term. And in February he announced a series of investments meant to increase testing capacity by scaling up the production of raw materials and establishing regional centers to distribute test kits and collect samples.

But Biden’s central focus in the early days of his term ultimately was on getting as many Americans vaccinated as possible, a campaign that diverted public attention from the testing initiative he’d entered office vowing to execute.

“Right from the start, the CDC, for lack of a better word, screwed up testing. They got the testing kits wrong; they sent out the wrong kits. Then we finally built up an infrastructure, but it came simultaneously with the vaccine, and we thought the vaccine would solve the problem and we didn’t need to maintain that infrastructure,” said Dr. Ezekiel Emanuel, a physician at the University of Pennsylvania who served on Biden’s Covid advisory team during the transition.

The White House rejects the notion that it prioritized vaccination at the expense of testing.

“That is not true at all,” Inglesby said. “It was never zero sum between the two.”

Still, without adequate testing, public health officials and hospitals aren’t in the best position to anticipate how many cases may be coming their way or how much treatment may be needed.

Testing is taking on an additional importance with the introduction of antivirals such as the recently authorized product from Pfizer, Paxlovid, which can reduce hospitalization by nearly 90% in high-risk adults. For that medication to work properly, the pills need to be taken within the first five days of symptoms occurring. The only way to know if those symptoms are caused by Covid is through testing.

“If you don’t have a strategy around testing, you’re just kind of shooting in the dark and really addressing issues as they come up,” said Lori Freeman, chief executive officer of the National Association of County and City Health Officials. “And I think we might be feeling the consequences of that right now.”

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CNN’s Jen Christensen, Nadia Kounang and Amanda Sealy contributed to this report.