Biden has promised 500 million free animated tests. Then he must find them.

WASHINGTON – As the United States saw a near-vertical increase in coronavirus cases in late December and a growing backlash over shortages of rapid tests, President Biden has promised that the administration his will send 500 million of it to the Americans for free.

There’s one big hitch: The administration has yet to secure a single test suite for the program. The notice sent officials hunting for stockpiles in warehouses around the country and uncommitted supplies from major manufacturers.

Today, the federal government is sending tens of millions of requested rapid tests through a new Postal Service website, which is heavily visited, with about 60 million households ordering the tests until Now, according to the White House. The country has a little more than double overall household, showing great interest. Currently, orders are limited to four pieces per household.

Test shortages have given the government a headache since the beginning of the pandemicand a resupply of home tests, which give results in about 15 minutes, may come too late, as the Omicron variation has peaked in many areas. But home deliveries and expanding access to tests in general are a notable turnaround for an administration that has already struggled to meet demand when it focused primarily on vaccinations.

It succeeded in part by transitioning into a new pool of players in a rapidly expanding market, including a company that had never done rapid tests before. The administration also spent billions of dollars late last summer and into the fall buying tests directly from manufacturers, while speeding up the review and licensing process for new tests.

Mr. Biden claimed the days before Christmas when the tests had disappeared from retail shelves. The world’s largest test manufacturers, already racing to meet skyrocketing demand from public and commercial buyers around the world, can’t deliver so many tests to Americans in such a short time. .

So initially the administration turned to a few little-known companies that had a supply of federally authorized tests in stock, ready to ship. One of them, Medea Inc., of Pleasanton, California, was previously imported vodka bottles are equipped with LED lights advertised by Shaquille O’Neal, drawing ridicule from a leading Republican senator in a recent hearing.

In mid-January, the administration announced a much larger set of contracts with test manufacturers – and plans to double the number of free tests Mr. Biden plans to send Americans, bringing the total. up one billion.

The program’s contractors have committed to providing more than 550 million tests, a White House spokesman said. These include Illinois-based Abbott Laboratories, which runs a popular at-home test called BinaxNOW and is receiving about $300 million; Roche, the Swiss pharmaceutical giant, is distributing tests conducted by a Korean manufacturer and is being paid roughly the same amount; and the German company Siemens Healthineers. Roche and Siemens were given federal approval for testing in December.

The administration made its biggest bet — with a $1.3 billion contract — on iHealth, a company based in Sunnyvale, California, that had never done rapid testing until late last year. Now it is a major supplier not only to the federal government, but also to states and cities. (administration announced another order with the company on Friday, buying nearly 105 million more test kits.)

The company, which previously focused on manufacturing medical devices such as forehead thermometers, received approval from the Food and Drug Administration in November. According to Jack Feng, chief executive officer of iHealth, The Chinese manufacturer has hired 16,000 more workers and sent more than 10 million tests per day to the United States on cargo jets.

Abbott said it produced 70 million tests in January and will grow to 100 million a month in March. Mr. Feng said iHealth is currently performing 300 million tests per month.

Officials said the federal government has contracted for how many tests the companies can perform, as long as they don’t disrupt other orders. Feng said the Biden administration has targeted iHealth because more established manufacturers have committed to short-term supply to other customers globally.

“We only focus on the US market,” he said.

When Mr. Biden took office last winter as the virus raged, he vowed to make testing cheap and accessible. He has established what he calls a “pandemic examination board” to improve supply and accessibility, but its work remains invisible. Although the first over-the-counter rapid antigen tests were authorized in December 2020, they were not available in pharmacies until last spring.

Some experts have said that the FDA slow review and allowed new tests last year because meticulous standards make the market’s rapid growth challenging, even during a public health emergency. In the fall, the agency worked with the National Institutes of Health to introduce an accelerated review process that has allowed the regulators to delete the tests within days of receiving the final data.

Now available 14 authorization of over-the-counter rapid antigen testscompared to about half a dozen at the end of summer.

The Biden Administration can also move more actively by Some experts say larger, European-style investments in at-home tests in early 2021 will ensure a larger, more stable market for manufacturers and allow the government to reserves for future spike variants.

Tom Inglesby, the White House’s testing coordinator, said last year the administration made a targeted effort to deliver tests. He cites billions of dollars worth of rapid and lab tests being delivered to schools and long-term care facilities.

Mr Inglesby said: “It’s portrayed somehow that the government is no longer interested in testing. “Absolutely not true.”

In the spring and early summer, cases of the virus dropped dramatically, and the need for home testing increased. Abbott get rid of test supplies in Maine and temporarily closed the plant in Illinois. At the time, the Centers for Disease Control and Prevention said that fully vaccinated people exposed to the virus did not need to be tested unless they had symptoms, that guidance was then reverse.

The administration didn’t make its most significant commitments to at-home testing until late summer and fall, when fewer tests were allowed. In September and October, the government pledge 3 billion dollars To secure the purchase of at-home tests, it helps companies like Abbott and Quidel keep supply lines open, officials said.

White House officials say the investment is now paying off as the tests return to drug shelves and are sent to community clinics and schools.

Mr Inglesby said the administration’s $3 billion investment had supported test producers as demand was substantially lower in the late summer and fall. The number of over-the-counter tests available to the US market, he said, increased from 25 million in August to 375 million last month, with another increase expected in February. that’s separate from the tests in the admin mail program.

The Biden administration also frequently invoked the Defense Production Act last year, which can be used to force companies to prioritize production of key supplies; Tim Manning, a White House supplies official, said they have also taken other actions with a similar effect, including giving pipette manufacturers better access to the resin needed for the kit. test tool.

The new accelerated review process has attracted interest from many test manufacturers, who must demonstrate that they can perform a large number of tests. A test, by Maxim Biomedicalwas authorized in mid-January after an expedited review.

It remains unclear whether a better supply of rapid tests could contain a potentially infectious variant like Omicron, which also overwhelms countries where such tests are widely used even before it appeared.

But the tests also have another important public health purpose: New treatments for the virus must be introduced early in the infection, so identifying cases quickly. Fast is very important.

The tests are also providing an extra layer of security for Americans, who are now more used to them. In one Axios-Ipsos . Poll conducted at the end of January, 44% of respondents said they had ordered free tests through the government. Eighty-four percent of respondents said they supported the plan, including the majority of unvaccinated respondents.

Sending tests by mail required an elaborate effort. The Department of Health and Human Services recently hired Steven Goddard, a senior FedEx official, to help with logistics. The Postal Service, which is managing the delivery, hire thousands of temporary employees and arrange dozens of finishing centers.

The website where people can order the tests for free – so far largely without problems – recommend using them at least five days after close contact with someone infected with the virus; if symptoms appear; or before gatherings, especially with vulnerable people.

The Biden administration has said it doesn’t cannibalize supplies of tests from states, because its contracts for the mail program stipulate that companies cannot pass on supplies to other customers. But Gene Burk, Connecticut’s chief procurement officer, said that iHealth told him the federal government contract initially slowed that company’s test shipments to his state, even though the problem was be remedied.

Mr. Burk added that although Connecticut is in talks with Roche to provide future trials, “their ability to deliver product to states is directly affected by their ability to meet their commitments.” with a federal contract.”

iHealth’s Mr. Feng admits that he initially gave preference to the federal government, and states have complained about slower deliveries.

Noting that mail-in tests are most likely coming in too late to have much of an effect on Omicron’s rise, Dr. Mark B. McClellan, a Duke University professor of health policy, said that one Biden’s other new policy, requiring insurance companies to reimburse people at home. testing, “seems like a more promising long-term direction.”

However, Mara Aspinall, an expert in biomedical diagnostics at Arizona State University who is also on the board of OraSure, which specializes in rapid coronavirus tests, said the Biden administration should use the lesson. that they have learned in the past six weeks.

“The world has changed,” she said. “American culture has changed. People are now willing and interested in doing Covid tests at home. ”

Sharon LaFraniere contribution report. Biden has promised 500 million free animated tests. Then he must find them.

Fry Electronics Team

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