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August 14, 2020

Covid-19 roundup: J&J, Moderna sign 'Operation Warp Speed' deals worth $1B+

Daily Briefing
    • RenalytixAI, a London-based diagnostics firm, is collaborating with Mount Sinai, Yale School of Medicine, the University of Michigan Medical School, Johns Hopkins University School of Medicine, and Rutgers New Jersey Medical School to conduct a multi-center clinical trial to predict long-term kidney disease risk in patients recovering from Covid-19, the disease caused by the new coronavirus. During the trial, researchers will use RenalytixAI's blood-based assay and data from patients' EHRs to predict their risk of progressive kidney decline (Gilmore, 360Dx/Modern Healthcare, 8/11).

    • Google Cloud AI, the Harvard Global Health Institute, and HCA Healthcare have collaborated to launch a dashboard, called Covid-19 Public Forecasts, that projects coronavirus cases, deaths, hospitalizations, and other metrics related to America's coronavirus epidemic over a 13-day period on both nationwide and state levels. Researchers at Google Cloud AI developed the dashboard using a new machine-learning approach that combines artificial intelligence (AI) and epidemiology to generate projections based on public data from various sources, including Johns Hopkins University, Descartes Lab, and the U.S. Census Bureau. Dario Sava, product manager at Google Cloud AI, in a blog post said frontline health care workers will be able to use the dashboard's projections to help with resource planning for personal protective equipment, staffing, and scheduling (Dyrda, Becker's Health IT, 8/4; Google Cloud release, 8/4).

    • FDA has issued an emergency use authorization (EUA) that allows clinicians to use Abiomed's left-sided Impella heart pumps to treat Covid-19 patients with certain heart and lung conditions. Under the EUA, clinicians can use the heart pumps to provide left ventricular unloading to their Covid-19 patients receiving extracorporeal membrane oxygenation treatment who develop either pulmonary edema, which is an abnormal buildup of fluid in the lungs, or myocarditis, which is an inflamed heart muscle (Vaidya, Becker's Hospital Review, 8/4).

    • The University of Virginia (UVA) received a $1.2 million grant from the National Science Foundation to fund a project aimed at creating a high-performance computing system that enables researchers across scientific fields to access Covid-19 data to support their studies. Researchers at UVA are leading the project with a team of researchers from Georgia Tech, Indiana University, Stanford University, and the University of Utah (Dyrda, Becker's Health IT, 8/4).

    • Moderna will use a tiered pricing system for its experimental coronavirus vaccine, the company's CEO Stéphane Bancel announced last week. Under the pricing system, Moderna will charge between $32 and $37 per dose for low-volume orders of the experimental vaccine—which Bancel said the company considers to be orders "in the millions" of doses—and charge a lower price per dose for high-volume orders. President Trump during a White House briefing on Tuesday announced the federal government reached a nearly $1.5 billion agreement with Moderna for 100 million doses of its experimental coronavirus vaccine if FDA finds the vaccine is effective enough to warrant an EUA. Under the agreement, the vaccine will cost the federal government $15.52 per dose. Separately, Moderna last week announced it will allow people with "controlled HIV who are not otherwise immunosuppressed" to participate in late-stage clinical trials for its coronavirus vaccine candidate, after facing pressure from advocacy groups to expand its test protocols to include people with HIV (Weixel, The Hill, 8/5; Court, Bloomberg, 8/6; Sullivan, The Hill, 8/11; Mason/O'Donnell, Reuters, 8/11; Higgins-Dunn, CNBC, 8/11; Wilkerson, Inside Health Policy, 8/12 [subscription required]).

    • FDA last week revoked its EUA for Autobio Diagnostics' antibody test after NIH's Frederick National Laboratory for Cancer Research evaluated the test and raised concerns about its accuracy. FDA said it "concluded that it is unlikely that this test is effective in detecting … antibodies and that the known and potential benefits of its use do not outweigh the known and potential risks" (AHA News, 8/10).

    • HHS and the Department of Defense last week announced the federal government reached a more than $1 billion deal with Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceutical Companies to manufacture 100 million doses of Janssen's experimental coronavirus vaccine. Under the deal, Janssen will begin to domestically manufacture doses of the experimental vaccine before the candidate enters late-stage clinical trials. J&J said the federal government could purchase an additional 200 million doses of the experimental vaccine under the agreement (Sullivan, The Hill, 8/5; HHS release, 8/5; Higgins-Dunn, CNBC, 8/5; Johnson & Johnson release, 8/5).

    • Virginia's Department of Health last week launched a coronavirus contact tracing app using technology developed by Google and Apple. The app, called COVIDWISE, uses Bluetooth signals to maintain an anonymous list of people's close encounters and allows people who test positive for the coronavirus to anonymously notify their contacts of their possible exposure to the pathogen. State officials said the app is not for direct contact tracing, but rather an "exposure notification" app (Dave, Reuters, 8/5; Rummler, Axios, 8/5; McCammon, NPR, 8/5).

    • Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during an online forum sponsored by Harvard T.H. Chan School of Public Health last week said the White House's coronavirus task force will investigate whether the virus can be transmitted via aerosols. Fauci also said the task force will examine whether T cells can build immunity against the new coronavirus (O'Reilly, Axios, 8/6).

    • NIH Director Francis Collins last week announced a study sponsored by NIH found that 21 existing drugs showed promise as treatments for Covid-19—and four of the drugs in combination with remdesivir appeared to block coronavirus infections. Collins said the results suggest there are several existing and experimental medications that possibly could be used to treat Covid-19 patients independently or in combination with other therapies (Lienhard, Inside Health Policy, 8/5 [subscription required).

    • About 2,000 families in 11 American cities are participating in a government-sponsored study examining how many children are infected with the coronavirus and how likely they are to transmit the pathogen to other children and adults. For the study, participants use testing supplies mailed to their homes to collect their own nasal swabs for coronavirus tests, as well as blood and stool samples. The participants mail their specimens to researchers, fill out questionnaires, and respond to text messages asking about symptoms. The results of the study are expected before the end of 2020 (Tanner, Associated Press, 8/8).

    • Pfizer last week announced it entered a multiyear agreement with Gilead Sciences to supply and manufacture Gilead's drug remdesivir, which is viewed as the most promising experimental treatment for Covid-19 so far. Pfizer said the agreement will help to boost supplies of the drug (Lovelace, CNBC, 8/7).

    • Epic Systems recently told employees that they did not have to return to in-person work after Public Health Madison and Dane County in Wisconsin raised questions about the company's ability to comply with guidelines on mitigating the new coronavirus' transmission. Epic, which has about 10,000 employees, had planned to begin a phased reopening to bring its employees back to work at its Wisconsin facility on Monday, but the organization has now decided to allow its employees to opt out of the plan. The announcement came after about 4,200 of its employees returned to work at one of the company's campuses in Verona, Wisconsin (Associated Press, 8/9).

    • Cincinnati Children's Hospital Medical Center, the University of Cincinnati, and Wysa have collaborated to launch an app aimed at helping people cope with anxiety related to the coronavirus pandemic. Cincinnati Children's Hospital said the app uses AI-powered chat bots to allow users to have conversations about their mental health and "offers nine exercises for coping with Covid-related anxiety, which employ cognitive-behavior therapy methods, visualization, relaxation, and other techniques to reduce stress" (Garner, Cincinnati Business Courier, 8/10).

    • Children's National Hospital and the University of Maryland, College Park late last month announced the winners of their virtual competition focused on new technologies that will improve pediatric care during America's coronavirus epidemic, awarding eight winners grants from FDA to create the new technologies. The winners included Children's Hospital of Philadelphia, which received $20,000 to develop a reusable transparent face mask that shows facial expressions, and Bloom Standard, which received $20,000 for its wearable, AI-powered ultrasound for infant cardiac and pulmonary screening and diagnostics (Drees, Becker's Health IT, 8/7).
    • The Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance said they will back Serum Institute of India (SII), the largest vaccine maker in the world, to manufacture 100 million low-cost doses of a coronavirus vaccine for lower-income countries once an inoculation is proven effective against the pathogen. SII under the agreement will price the vaccine doses at less than $3 (Bellman, Wall Street Journal, 8/7).

    • FDA Commissioner Stephen Hahn and Peter Marks, director of FDA's Center for Biologics Evaluation and Research, in a JAMA viewpoint wrote that they plan to convene FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review any coronavirus vaccine for an EUA or licensure. Hahn and Marks said it'll be necessary for FDA to hold a public meeting with the VRBPAC because of the vaccine's potential widespread use and the need for transparency (Wang, Inside Health Policy, 8/10 [subscription required]).

    • CVS Health and Salesforce on Monday announced they are partnering on a return-to-work platform. The platform will combine CVS' Return Ready testing solution with Salesforce's Workplace Command Center to track coronavirus testing and provide wellness monitoring, as well as manual contact tracing. CVS CMO Troyen Brennan said, "While Covid-19 testing is an important tool to responsibly reopen worksite and campus locations, a comprehensive strategy requires wellness monitoring and contact tracing to help prevent an onsite outbreak and spread of the virus" (Minemyer, FierceHealthcare, 8/10).

    • Karen Lynch, Aetna's president and EVP of its parent company, CVS, told the Hartford Courant that most of Aetna's employees will work remotely at least through the beginning of 2021. Aetna's employees who do return to the company's office will be required to undergo temperature screenings, wellness self-checks, wear face coverings, and practice physical distancing (Haefner, Becker's Payer Issues, 8/11).

    • Alphabet's Verily on Tuesday announced that it has developed its own coronavirus testing lab in San Francisco to help increase the country's capacity to conduct coronavirus tests. The company said the lab is CLIA-certified, which means it meets the necessary standards to conduct clinical trials (Farr, CNBC, 8/11).

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