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HHS Testing Czar Rips Nevada for Stopping Rapid Tests in Nursing Homes

WASHINGTON — Nevada public health officials’ recent actions preventing nursing homes from using rapid screening tests for COVID-19 are “unjustified” and don’t follow the science on testing, Department of Health and Human Services (HHS) “testing czar” Adm. Brett Giroir, MD, said Friday.

The state’s actions are “not scientifically valid. They must cease their prohibition immediately,” Giroir said on a phone call with reporters. “If you need technical support,” he told the nursing homes, “we are enthusiastic to do more. Lives are at stake and our administration is not going to allow action to risk our seniors or any other vulnerable or underserved population.”

Letter Sent to Nursing Homes

On October 2, the Nevada Department of Health and Human Services sent a letter to healthcare providers and long-term care facilities, noting that the Centers for Medicare & Medicaid Services had sent point-of-care antigen tests to nursing homes across the country — specifically, the Quidel Sofia test and Becton Dickinson’s Veritor test. The letter noted that according to the FDA’s emergency use authorization data, Quidel claimed 87% sensitivity and 100% specificity for its test, while Becton Dickinson’s numbers were 97.5% and 100%, respectively.

“However, this was based on extremely limited data,” wrote Ihsan Azzam, MD, PhD, the state’s chief medical officer, and two colleagues. The state conducted its own test after it “started receiving anecdotal reports from SNFs [skilled nursing facilities] that individuals with a positive antigen test were subsequently testing negative” with polymerase chain reaction (PCR) assays, generally considered the most accurate. The state looked at data from 12 nursing homes that conducted 3,725 rapid tests, of which 60 came back positive. Of those, 39 were sent for PCR testing; 16 (40%) came back as true positives while 23 (60%) were false positives.

“Possible reasons for conflicting test results include lack

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Trump’s coronavirus vaccine czar is siding with the FDA on safety standards that make a vaccine approval unlikely if not impossible before the election



a man wearing a suit and tie: Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon


© AP Photo/Alex Brandon
Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon

  • The man in charge of the Trump administration’s efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine.
  • “I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the scientific head of Operation Warp Speed, said in a Tuesday morning phone interview. “It’s very important.”
  • That requirement will almost certainly prevent a vaccine from gaining emergency approval before the presidential election on November 3.
  • The agency spelled out its requirements Tuesday by releasing guidance for industry. Top White House officials reportedly opposed that guidance.
  • For more stories like this, sign up here for our daily healthcare newsletter.

In the race to develop a coronavirus vaccine, US regulators just laid down guidelines that make it difficult, if not impossible, for any COVID-19 shot to win emergency approval before Election Day.

The US Food and Drug Administration is asking vaccine developers to submit at least two months of safety data as part of an emergency-approval application, according to documents released Tuesday. The White House reportedly opposed that measure, with President Donald Trump saying on September 23 it “sounds like a political move.”

Despite pushback from the administration, the FDA publicly released those guidelines on Tuesday. And the man leading the US government’s efforts to help develop a vaccine said he supports the FDA.

“I do think it is appropriate to set the threshold of safety follow-up,” Moncef Slaoui, the chief advisor to Operation Warp Speed, told Business Insider in a Tuesday phone interview. “It’s very important.” Business Insider asked

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