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October 23, 2020

Covid-19 roundup: Pfizer will not seek FDA approval for Covid-19 vaccine until late November

Daily Briefing
    • The Cleveland Clinic announced it will partner with BreathTech to develop a non-invasive test that can use a person's breath to determine if he or she has Covid-19. According to the companies, the self-administered breath test—adapted from BreathTech's BreathTest 1000 mass spectrometer—could provide results in as little as one minute. The two companies said they will begin a clinical trial with the test in the coming months (Vanac, Columbus Business First, 10/21).

    • CMS on Thursday announced it will pay labs that process Covid-19 tests more if those tests are processed quickly. Under the new guidelines, which take effect on Jan. 1, 2021, labs that process Covid-19 tests within two days will receive $100 per test, while labs that process tests in more than two days will receive $75 per test ("Transformation Hub," Modern Healthcare, 10/15).

    • FDA has reissued emergency use authorization (EUA) for KN95 respirators, which have not been approved by CDC's National Institute for Occupational Safety and Health. The masks, which are made in China, are supposed to provide users with protection similar to N95 masks. According to Suzanne Schwartz, director of FDA's Office of Strategic Partnerships and Technology Innovation, FDA completed a shortage assessment and determined that reissuing the EUA "was appropriate to reflect the current U.S. demand for these products" (Anderson, Becker's Hospital Review, 10/16).

    • Mayo Clinic on Monday announced it is partnering with Safe Health Group to improve access to treatment for common medical conditions, including Covid-19 and sexually transmitted infections. The companies have designed an app for both smartphones and desktop computers, called HealthCheck, which will connect providers, test distributors, and patients, and provide real-time health status verification, according to Ken Mayer, Safe Health's CEO (Landi, Fierce Healthcare, 10/12).

    • Pfizer this week announced it received FDA approval to expand its Covid-19 vaccine trial to children as young as 12 years old, marking the first time children will be included in a Covid-19 vaccine trial in the United States. Pfizer also announced on Friday that it won't be seeking an emergency use authorization from FDA for its Covid-19 vaccine before the third week of November. Pfizer CEO Albert Bourla in a statement said the company may have preliminary data on the effectiveness of its vaccine candidate by the end of October but will still need to collect data on safety and manufacturing data. Bourla said Pfizer will apply for FDA approval "soon after the safety milestone is achieved in the third week of November" (Aubrey, "Shots," NPR, 10/13; Thomas/Weiland, New York Times, 10/16; Mishra/Erman, Reuters, 10/16; Hart, Forbes, 10/19).

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