Biden admin preps for next pandemic as Delta variant surges

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The Biden administration is rethinking its approach to Covid-19 testing as the pandemic enters an uncertain phase — one in which new infections have dropped to the lowest level since the spring of 2020, but the highly contagious Delta variant is driving fresh outbreaks.

Federal health officials, along with testing labs and test makers, are weighing how to implement the lessons they have learned from this pandemic to prepare for the next one. That includes what types of government incentives could help keep companies prepared to quickly develop tests in the face of a new emergency, and whether to stockpile key testing supplies. The administration also recently retooled the leadership of its Covid-19 testing and diagnostic workgroup.

But with newer variants like Delta circulating, the administration must also ensure that existing tests are capable of detecting emerging strains — and maintain enough testing capacity to detect and tamp down new bursts of infections.

The government is working with the diagnostics industry to ensure the gains in domestic manufacturing are not lost over time. But it is not yet out of the danger zone with Covid-19. With public health experts warning that Delta could drive up cases in under-vaccinated areas, the Biden team is pushing ahead with plans to establish testing programs in schools and homeless shelters as the fall approaches. It is also pushing test makers to create products that can be used at home to simultaneously screen for flu, Covid and other common respiratory viruses.

“I do think it’s important for HHS, the federal government and the lab community to seriously think about not needing to ramp up to where we were in January and last fall, but to be prepared for surges, and it may not be uniform,” said Scott Becker, CEO of the Association of Public Health Laboratories.

Covid-19 testing numbers have fallen significantly since infections peaked in late January. But with less than 50 percent of the U.S. population fully vaccinated, and many states reporting vaccination rates in the 30s or 40s, the nation is vulnerable to highly contagious variants like Delta.

An official at the Department of Health and Human Services told POLITICO the government is weighing how to ensure the U.S. diagnostics industry does begin a future pandemic “from a standing start.”

“It does mean that we will need to have some things in stockpile to cover ramp up when a new pandemic arrives, or a new major epidemic arrives,” the official said.

The demand for Covid-19 testing ballooned early in the pandemic and did not let up for more than a year, driving unprecedented cooperation between federal health agencies and the testing industry. Other recent disease outbreaks or threats, such as those involving the Zika and Ebola viruses, petered out without a need for large-scale testing. The Trump and Biden administrations have spent hundreds of millions of dollars to shore up domestic manufacturing of Covid-19 tests, and Congress has authorized billions to pay for screening programs.


Now, halfway through the second year of the pandemic, the Biden administration has shaken up the leadership of the federal testing response. Michael Iademarco, who led HHS’ Covid-19 testing and diagnostic working group for the past seven months, is returning to CDC. Dean Winslow, a professor of medicine at Stanford University with expertise in infectious diseases, is taking charge of the working group, which has been instrumental in planning Biden’s school testing efforts.

Jay Butler, the CDC’s deputy director of infectious diseases, has been deployed to HHS’ Office of the Assistant Secretary for Preparedness and Response to help plan the government’s Covid-19 testing strategy as the pandemic evolves.

“This is a sign of how seriously we take testing issues now and also to be thinking about the future and building the infrastructure we need for testing to prepare for the next pandemic,” the HHS official said. “Fortunately, right now, it looks like our vaccine is very effective against variants, but we don't know what will happen in the future. So we are going to need a very robust testing strategy and execution of that strategy through the end of this pandemic.”

The federal government is exploring ways to ensure the public-private partnerships that have been developed during the pandemic do not end when the current crisis does.

“In terms of financial arrangements, we are exploring what does industry need to be ready, much more ready, for infectious disease emergencies before the next pandemic,” the HHS official said. “A lot of the experience over the last year has created an industrial base expansion program.”

Maintaining a stockpile of testing supplies — such as swabs, reagents or tubes to transport patient samples — appears to be one area of interest.

“We are examining and talking to industry about the best way to make industry ready in as short a time as possible” at the beginning of a future pandemic, the HHS official said.

The government is also trying to incentivize companies to develop at-home diagnostic tests that can test for multiple respiratory viruses, including Covid-19, at the same time. While the U.S. recorded virtually no flu cases during the 2020-21 flu season, public health labs are already preparing for the potential reemergence of flu this fall and winter alongside regional outbreaks of Covid-19, Becker said. That could prove tricky for doctors, because the early symptoms of the two diseases can be similar.

The NIH is leading the federal charge to support development of new and better Covid-19 tests through its venture-like Rapid Acceleration of Diagnostics program. It is set to hand out another $100 million to support commercialization of new testing technologies before the end of 2021, said Bruce Tromberg, the NIH scientist leading the initiative.

“We have several manufacturers that we’re working with as part of RADx to try to stimulate more approaches that could rapidly assess variants,” he said. “You do a swab, you get it in your device, it could look for 27 variants of interesting concern all simultaneously, without having to do [genetic] sequencing.”

Tromberg hopes that the government will fund another round of RADx projects aimed at developing tests that can determine the durability of vaccine protection.

“If we're able to continue the program into next year, that will be a significant expansion,” Tromberg said. “And we'll know about that in the next few months if we'll be able to continue.”

In the long term, a yearslong effort on Capitol Hill to develop an overhaul of how the U.S. regulates medical tests may shape the ability of the country to avoid the early pitfalls of the Covid-19 response. That includes confusion over how FDA regulates different types of tests, such as those intended for use in a single lab versus those created for wider use. The legislation, called the VALID Act, would create a single regulatory framework for both of those types of tests. It would also codify test makers’ ability to market tests that meet basic accuracy standards during an emergency while FDA conducts a formal review.

One industry source said one takeaway from the Covid-19 pandemic is that there is a public health benefit when the performance and availability of crucial diagnostic tests is publicly shared, something they said was a unique aspect of the Covid-19 pandemic.

“The real story is that transparency into what tests exist, it turns out it matters a lot,” the industry source said. “Covid testing was unusual in the sense that we actually got a look to understand what tests were actually available.”

But the current pandemic is not over. NIH’s Tromberg cautioned that even if U.S. Covid-19 cases are kept under control, infections in other countries could give rise to new and potentially dangerous variants — and testing will need to keep pace.

“We know that the variants are changing over time,” Tromberg said. “And until we bring the pandemic under control on a global basis, those variants that are cooking in other parts of the world are going to come back to bite us.”

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