WASHINGTON – President Joe Biden’s plan to spend more than $ 7 billion on new antiviral pills to treat Covid as a key tool in the fight against the pandemic could be complicated by a testing crisis.
The pills, manufactured by Pfizer and Merck and approved this week by the Food and Drug Administration, have been shown to reduce the risk of hospitalization and death from Covid. The United States has secured contracts for enough pills from each drugmaker to treat up to 15 million people next year.
The drugs need to be taken within the first five days of symptom onset to be effective, which means patients should be tested, tested positive, and get a doctor’s prescription within days.
Right now, patients in areas with the largest increase in cases have waited several days for test results, and many have struggled to obtain rapid home tests. While the demand for testing has increased due to vacation travel, it is also driven by an increase in the number of cases, which have increased by 25% over the past week.
The demand for testing is also expected to increase. Employers will be required, under Biden’s vaccination mandate, to prove that their unvaccinated employees have been tested weekly, and schools will rely on the testing to keep children in class.
Demand for testing could slow by the time Merck and Pfizer pills become widely available in early 2022, although the University of Washington’s Institute for Health Metrics and Evaluation predicts that the number of daily tests will continue to increase. until 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 current levels. The institute does not have a projection of when cases could return to pre-omicron levels.
Merck is expected to deliver 3 million courses of its drugs in January and Pfizer plans to have only 265,000 courses of treatment available by January, according to White House Covid Coordinator Jeff Zients. In clinical trials, Pfizer’s treatment was found to be much more effective than Merck’s at preventing hospitalization in high-risk groups – 89% versus 30%.
With limited testing capacity and so many people expected to become infected in the coming months, Ali Mokdad, director of population health strategy at the University of Washington, said the United States may have to reserve the testing in certain groups, such as those at high risk of becoming seriously ill and needing testing to receive any of the antiviral treatments.
“Let’s keep the test to them because they need the drugs and have to decide what to do. We have to be very careful about how we use the tests,” Mokdad said. “Use it for travel or to return to work or especially if you need to take antivirals. We may need to ration testing, we may need to ration hospitalizations.”
The National Institutes of Health’s Covid-19 treatment guidelines panel on Thursday released interim recommendations on how doctors should prioritize who should receive antiviral pills.
“Logistics or supply constraints may make it impossible to offer outpatient therapy available to all eligible patients,” the panel said in a statement. When availability is limited, the panel said, “patients at the highest risk for clinical progression should be prioritized to receive these therapies.”
In the New York area, emergency care provider CityMD said on Wednesday the average processing time for PCR tests was five to seven days, longer than usual due to increased lab tests. national. Residents of Washington, DC have been told that their PCR results could take up to five days from a site run by the city. House Majority Whip Jim Clyburn said on Wednesday he had to wait more than 56 hours to get his positive test result.
The federal government also plans to open more free test sites in addition to the 20,000 federal test sites already in operation.
This could help reduce the long queues that have formed at many testing centers, but will not solve the long waits for results as labs are inundated with requests.
Right now, state health labs say they’re nearing full capacity for the number of tests they can perform and won’t be able to respond to an increase in the nationwide, said Marcus Plescia, chief medical officer of the Association of State and Territory Health Officials.
“What we’re hearing, what’s really, really important, is the state public health labs, they really don’t have much more capacity for an outbreak,” Plescia said. “Any push will have to come from the commercial sector. The state labs, a lot of them, really raise the issue that the federal government can’t view them as a major source of capacity during a big increase. “
Commercial labs, which processed the majority of the country’s Covid tests, are starting to experience delays given the surge in demand in some areas, such as New York and New Jersey.
The majority of Quest Diagnostics’ Covid tests are processed within a day, but people in some areas may have to wait longer, company spokesperson Kim Gorode said.
“We continue to experience tremendous demand for Covid-19 molecular diagnostic testing,” Gorode said. “We continue to perform and report the majority of Covid-19 tests in one day; however, people in some areas can experience more than a one-day delay. “
In recent days, the Biden administration has focused on improving access to home Covid testing. Biden announced this week that the U.S. government will purchase 500 million tests to distribute for free starting in January.
These 500 million tests will add to the more than 200 million tests per month that companies are already producing. Administration officials declined to say over what period these tests would be purchased and distributed.
But public health experts warn it could be too little, too late, and say the administration should have done more to prepare for a rise like the one the United States is currently experiencing due to the omicron variant.
“The White House has been too often in reaction mode, without 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 talking about half a billion test kits? What is still insufficient besides. We need more than that. Why haven’t we been doing this all year? “
It is not known whether a home test will be enough for doctors to write a prescription for any of the Merck or Pfizer treatments, or whether patients will need to have a confirmatory lab test.
While the administration plans to start distributing the free home tests next month, the contract to manufacture these tests has yet to be finalized, the website where people can request the tests is yet to be completed. running and administration officials are still figuring out the details. such as the number of tests each person can request.
White House press secretary Jen Psaki said Thursday the administration has been bracing for the need for more testing since the fall, when it announced it would spend $ 3 billion on testing quick to distribute in places like food banks and community clinics to encourage manufacturers to ramp up production.
“We have prepared for a whole host of contingencies throughout this process,” Psaki said. “This is why we have had an adequate supply of vaccines. This is why we have had an adequate supply of masks and why we have made efforts to aggressively step up our testing over the past few months.”