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Cue Health awarded $481 million to scale up production of COVID-19 test: HHS

(Reuters) – The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and Human Services said on Tuesday.

The company will raise the domestic production of COVID-19 test kits to 100,000 per day by March 2021 under the deal and deliver 6 million tests and 30,000 instruments to the government to support its response to the pandemic, the health agency said.

The point-of-care test can detect the novel coronavirus in about 20 minutes with nasal swab samples collected using a Sample Wand from the lower part of the nose, the HHS said.

The system also allows results to be sent to a mobile phone via an app.

The company’s test kit was approved by the U.S. Food and Drug Administration (FDA) in June for emergency use in patient care settings under the supervision of qualified medical personnel.

The development of the company’s health platform was supported by funding from the Biomedical Advanced Research and Development Authority (BARDA) for a molecular influenza test, starting in 2018, the department said.

BARDA later expanded the collaboration with the company to include the development of Cue’s COVID-19 test, it added.

(Reporting By Mrinalika Roy and Vishwadha Chander in Bengaluru; Editing by Anil D’Silva)

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HHS pushes back against Nevada’s rapid test pause for Covid-19

The federal government is pushing back on an order from Nevada’s department of health to suspend rapid Covid-19 tests in nursing homes — suggesting the decision “can only be based on a lack of knowledge or bias,” according to a letter signed by Dr. Brett Giroir, assistant secretary for the U.S. Department of Health and Human Services.

The move comes one week after the Nevada Department of Health and Human Services mandated that long-term care facilities in the state stop using two Covid-19 antigen tests that had been supplied by the federal government.

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State health officials in Nevada said the antigen tests, which can deliver results within 15 minutes, had an unusually high number of false positives. That indicates a person is infected when in fact he or she is not.

Covid-19 antigen tests are designed to detect certain proteins on the surface of the coronavirus. More sophisticated tests — called PCR tests — look for the virus’s genetic material in a sample. These are more accurate, but can take up to three days to get a result.

The federal government began rolling out the antigen tests, made by Quidel and Becton, Dickinson and Company, to nursing homes nationwide in August.

Quick results are important, because “nursing homes have accounted for as much as 40 percent” of the overall Covid-19 deaths in the U.S., Giroir said Friday on a call with reporters.

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But within a month of that test rollout, the Nevada department of health said it began to receive “anecdotal reports” of false positives. By October, health officials in the state determined the rate of false positives was 60 percent.

That’s a major problem, said Dr. Michael Wasserman, president of the California Association of Long Term Care Medicine. “If you have a large number of false positives, it will throw your facility into complete chaos and panic.”

“We’re already in a pandemic,” Wasserman said. “We don’t need more chaos.”

On Oct. 2, health officials in Nevada sent a letter to its nursing home facilities advising them “to immediately discontinue the use of all Covid-19 point of care (POC) antigen tests until the accuracy of the tests can be better evaluated.”

Part of the issue relates to staffing, which is already a stretched resource at many nursing facilities.

Indeed, the tests were meant for workers inside nursing homes, including possible asymptomatic staffers.

“This is obviously necessary to keep an unaware infected individual from coming into a nursing home, and starting a potentially devastating outbreak,” Giroir said. He added that if an individual does have a false positive, it would be detected by a PCR test within 48 hours, and the person could return to work. (The Centers for Disease Control and Prevention recommends that positive antigen tests are confirmed with a PCR test.)

But Wasserman said the false positives can decimate a nursing home’s staff.

“You already have people who

HHS Secretary Azar says U.S. could have enough doses for every American by March

Alex Azar, secretary of Health and Human Services (HHS), wears a protective mask during a House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C., U.S., on Friday, Oct. 2, 2020. Azar is appearing before the committee to testify on the coronavirus crisis and the Trump administration’s portrayal of Covid-19 deaths. Photographer: Michael A. McCoy/The New York Times/Bloomberg via Getty Images

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Health and Human Services Secretary Alex Azar said Thursday the U.S. could have enough Covid-19 vaccine doses for every American as early as March, a more optimistic estimate than President Donald Trump has publicly said.

The Trump administration’s coronavirus vaccine program Operation Warp Speed expects to have up to 100 million doses by the end of the year, Azar said during a keynote speech at the Goldman Sachs Healthcare virtual event on the coronavirus. That’s “enough to cover especially vulnerable populations,” he said. 

“We project having enough for every American who wants a vaccine by March to April 2021,” he added. 

Because of the pandemic, U.S. health officials have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.

Azar said the U.S. is currently manufacturing doses for all six potential vaccines backed by the U.S. government across more than 23 manufacturing facilities. That includes vaccines from Moderna, Pfizer, AstraZeneca and Johnson & Johnson, which are all in late-stage testing. The U.S. is also obtaining the needles, syringes, bottles and other supplies needed for immunizations, he said. 

He touted the U.S. government’s partnership with medical supply company McKesson, which was tapped as the main distributor for Covid-19 vaccines.

“We are immensely pleased with our success so far,” he said. 

Trump has repeatedly insisted a vaccine could be authorized for emergency use as early as October with enough vaccine doses for every American by April. 

Azar said Thursday that U.S. health officials believe authorizing a vaccine for emergency use is appropriate in “only specific circumstances,” where there are “sufficient amounts of vaccine already manufactured.” 

The Centers for Disease Control and Prevention outlined a sweeping plan last month to make vaccines for Covid-19 available for free to all Americans. In the plan, the CDC said it anticipates a coronavirus vaccine will initially be granted an emergency use authorization before a full formal approval.

Much of the guidance, but not all, described in the plan will overlap with many routine activities for immunizations and pandemic influenza planning, CDC Director Dr. Robert Redfield said at the time.

When larger quantities of vaccine become available, the CDC said, there will be two simultaneous objectives: to provide widespread access to vaccination and to ensure high uptake in target populations, particularly those who are at high risk of death or complications from Covid-19.

Azar’s comments come as infectious disease experts and scientists fear a Covid-19 vaccine will be distributed before it’s been adequately tested. 

Earlier this week,

HHS whistleblower Rick Bright resigns from government

Rick Bright, the federal vaccine chief-turned-whistleblower who was reassigned to a different agency and subsequently criticized the Trump administration’s pandemic response, has left the federal government, Bright’s lawyers announced on Tuesday.

“Dr. Bright was forced to leave his position at NIH because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance and disrespects career scientists, resulting the [sic.] in the sickness and death of hundreds of thousands of Americans,” lawyers Debra Katz and Lisa Banks said in a statement.

HHS declined comment.

“We can confirm that Dr. Bright has resigned, effective today,” an NIH spokesperson said, adding that the agency “does not discuss personnel issues beyond confirming employment.”

Bright was abruptly removed as director of the Biomedical Advanced Research and Development Authority in April and reassigned to NIH, and he alleges that he was demoted because he opposed political pressure linked to an unproven Covid-19 treatment. In his updated filing with the Office of Special Counsel, Bright said that he was assigned “no meaningful work” at NIH since Sept. 4, further alleging that NIH Director Francis Collins “declined to support” his recommendations about coronavirus testing “because of political considerations.”

Bright testified to a House panel in May that he was punished by Health and Human Services Department leaders for raising concerns about hydroxychloroquine, the drug favored by President Donald Trump to treat the coronavirus despite scant evidence. Bright also used the hearing and other media appearances to speak out against the administration’s handling of the pandemic, saying that HHS had missed opportunities to prepare for the spread of Covid-19 and raising further charges of cronyism.

Bright appears in an upcoming documentary, “Totally Under Control,” which faults the Trump administration’s handling of the outbreak and is set to be released next week. The New York Times first reported Bright’s resignation.

HHS has spent months rebuffing Bright’s claims, saying that as vaccine chief he lacked full visibility into the administration’s efforts and noting that Bright played a key role in the government’s acquisition of hydroxychloroquine. The health department also issued a document called “CLAIM vs. REALITY” that sought to rebut Bright’s points.

Meanwhile, Trump repeatedly dismissed Bright as a “disgruntled” employee.

Other officials have subsequently echoed Bright’s criticisms of the Trump administration’s handling of the outbreak, including Olivia Troye, who advised Vice President Mike Pence on the coronavirus response before leaving the White House this summer.

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