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Testing logjams could hinder Biden's multibillion-dollar bet on Covid pills

Patients have to first test positive for Covid to get a prescription for the drug, which needs to be taken within the first five days of the onset of symptoms to be effective.
Image: Pfizer's COVID-19 pill Paxlovid is manufactured and packaged
Paxlovid, Pfizer's antiviral pill, is manufactured in Freiburg, Germany.Pfizer

WASHINGTON — President Joe Biden’s plan to spend more than $7 billion on new anti-viral pills to treat Covid as a key tool in the fight against the pandemic could be complicated by a testing crunch.

The pills, made by Pfizer and Merck and approved this week by the Food and Drug Administration, have been shown to reduce the risk of Covid hospitalization and death. The U.S. has secured contracts for enough pills from each drugmaker to treat as many as 15 million people next year.

The drugs need to be taken within the first five days of the onset of symptoms to be effective, meaning patients would have to get a test, receive a positive result and get a prescription from a doctor within a matter of days.

Right now, patients in areas seeing the biggest rise in cases have waited several days for test results, and many have found it difficult to procure at-home rapid tests. While testing demand has risen as a result of holiday travel, it is also being driven by a surge in cases, which are up 25 percent over the last week.

The demand for testing is also expected to increase. Employers will be required under Biden's vaccine mandate to prove their unvaccinated employees have been tested weekly, and schools will rely on testing to keep children in the classroom.

The demand for testing may slow by the time the Merck and Pfizer pills are widely available in early 2022, although the Institute for Health Metrics and Evaluation at the University of Washington projects the number of daily tests will continue to increase through April. The institute estimates that Covid infections will peak in February with 2.8 million daily infections, and the number of cases will then take another two months to return to the current levels. The institute does not have a projection for when cases could return to pre-omicron levels.

Merck is set to deliver 3 million courses of its medicine in January and Pfizer plans to have just 265,000 treatment courses available by January, according to White House Covid coordinator Jeff Zients. In clinical trials, Pfizer's treatment was shown to be far more effective than Merck's in preventing hospitalization in high-risk groups— 89 percent compared to 30 percent.

With limited testing capacity and so many people projected to get infected in the coming months, Ali Mokdad, chief strategy officer of population health at the University of Washington, said the U.S. may need to reserve testing for certain groups, like those at high risk of getting severely ill who need a test to get one of the antiviral treatments.

"Let's save the test for them because they need the medication and need to decide what to do. We need to be very careful with how we use testing," said Mokdad. "Use it to travel or to go back to work or especially if you need to get antivirals. We may have to ration tests, we may have to ration hospitalizations."

On Thursday, the National Institutes of Health's Covid-19 Treatment Guidelines Panel released interim recommendations for how doctors should prioritize who should receive the antiviral pills.

"Logistical or supply constraints may make it impossible to offer available outpatient therapies to all eligible patients," the panel said in a statement. When there is limited availability, the panel said, "patients at highest risk of clinical progression should be prioritized to receive these therapies."

In the New York region, urgent care provider CityMD said Wednesday that the average PCR test processing time was five to seven days, longer than usual due to increased national laboratory testing. Residents of Washington, D.C., were told their PCR results could take up to five days from a city-run site. House Majority Whip Jim Clyburn said Wednesday that he had to wait over 56 hours to get his positive test result.

The federal government is also planning to open more free testing sites in addition to the 20,000 federal testing sites already up and running.

That could help cut down on long lines that have been forming at many testing centers but won’t address long waits for results as labs become inundated with requests.

Right now, state health labs say they are near capacity for how many tests they can do and won’t be able to meet a nationwide surge, said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.

“What we are hearing, which is really, really important, is the state public health labs, they really don’t have a whole lot more capacity for a surge,” said Plescia. “Any surge is going to have to come from the commercial sector. State labs, lots of them, are really raising the issue that the federal government can’t look to them to be a major source of capacity in a major surge.”

Commercial labs, which have been processing the majority of the country’s Covid tests, are starting to see delays given the surge in demand in certain regions, like New York and New Jersey.

A majority of Quest Diagnostics' Covid tests are processed within one day but people in some regions may have to wait longer, said company spokesperson Kim Gorode.

“We continue to experience extraordinary demand for Covid-19 molecular diagnostic testing,” said Gorode. “We continue to perform and report the majority of Covid-19 tests within one day; however, people in some regions may experience more than a one-day turnaround time.”

In recent days, the Biden administration has focused on improving access to at-home Covid tests. Biden announced this week that the U.S. government would buy 500 million tests to be distributed for free starting in January.

Those 500 million tests will be on top of the more than 200 million tests a month companies have already been producing. Administration officials have declined to say over what time period those tests would be procured and distributed.

But public health experts warn that could be too little, too late, and say the administration should have done more to prepare for a surge like the one the U.S is experiencing now due to the omicron variant.

"The White House has been too often in reaction mode, not being proactive," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, speaking on MSNBC this week. “Why only now are we even talking about half a billion testing kits? Which is still inadequate, by the way. We need far more than that. Why haven't we been doing this all year?"

It is unclear whether an at-home test will be enough for doctors to write a prescription for one of the Merck or Pfizer treatments or whether patients will have to get a confirmatory laboratory test.

While the administration plans to start distributing the free at-home tests next month, the contract for manufacturing those tests has yet to be finalized, the website where people can request the tests isn’t running yet, and administration officials are still figuring out details like how many tests each person can request.

White House press secretary Jen Psaki said Thursday the administration has been preparing for the need to ramp up testing since the fall, when it announced it would spend $3 billion on rapid tests to distribute at places like food banks and community clinics to incentivize manufacturers to ramp up production.

"We've been preparing for a range of contingencies all along throughout this process," Psaki said. "That's why we have had ample vaccine supply. That's why we have had ample mask supply and why we have worked to ramp up aggressively our testing over the past few months."