June 15, 2020

Covid-19 roundup: FDA tightens reuse policies for respirators

Daily Briefing

    Moderna's new coronavirus vaccine candidate enters final testing stages, Mayo Clinic develops a test to identify neutralizing coronavirus antibodies, and more.

    • Only a few states have indicated they plan to use new contract tracing technology developed by Apple and Google, with many states saying they plan to rely on human contact tracers, according to a Business Insider survey of state health agencies. According to Business Insider, neither Google nor Apple responded to a request for comment on the findings (Holmes/Langley, Business Insider, 6/10).
    • The American College of Cardiology has launched a weekly, no-cost education series on cardiac care that will highlight research and best practices for treating cardiac patients amid America's new coronavirus epidemic. The series will begin June 6 and end July 2 (Vaidya, Becker's Hospital Review, 6/9).
    • The Biomedical Advanced Research and Development Authority (BARDA) on Tuesday awarded AstraZeneca with $23.7 million in funding to support the development of a monoclonal antibody treatment for the new coronavirus. The funding, which AstraZeneca received under its collaboration with BARDA and the Defense Advanced Research Projects Agency, is meant to help the drugmaker move two potential antibody therapies into clinical studies by the end of the summer. Separately, AstraZeneca on Thursday announced it will work with Emergent Biosolutions to help produce 300 million doses of its potential vaccine against the new coronavirus. The vaccine currently is in mid-stage trials (Aripaka, Reuters, 6/9; Adams, Becker's Hospital Review, 6/9; Joseph, Reuters, 6/11).
    • The Environmental Protection Agency (EPA) on Thursday ordered Amazon and eBay to stop selling products containing toxic substances that are being sold as products that can fight off the new coronavirus. The order bans the companies from selling such products containing pesticides and chemicals like chlorine dioxide and methylene chloride. EPA ordered Amazon to stop selling over 30 such products and eBay to stop selling more than 40 such products (Hagemann, NPR, 6/11).
    • FDA recently updated its guidelines on reusing medical masks, saying it can no longer approve decontaminating and reusing certain N95 masks that were made in China because the masks "may vary in their design and performance." FDA also restated that sanitized masks should "only be used" when new N95 masks are not available (Healy, WBUR, 6/8; AHA release, 6/8).
    • FDA last week issued an emergency use authorization for Phosphorus Diagnostics' saliva-based testing kit for the new coronavirus. The $140 kit allows people to take their own saliva samples and send them to the company's lab for testing. The company said people should be able to access their results within 72 hours after the laboratory receives the sample (Joseph, Reuters, 6/8).
    • GlaxoSmithKline (GSK) on Tuesday announced the company has started a U.S. trial of an experimental rheumatoid arthritis drug called otilimab on patients with pneumonia caused by Covid-19. The company said it has previously found the drug can reduce the effect the new coronavirus has on patients' lungs, though the drug does not appear to treat the virus directly (Burger, Reuters, 6/9).
    • Google last week announced that Google Maps in the coming weeks will begin providing users with alerts about local restrictions related to the new coronavirus. For instance, Google Maps will remind users driving to a coronavirus testing center to "verify eligibility and facility guidelines to avoid being turned away." Google Maps also will warn users if there is a Covid-19 checkpoint on their route, the company said (Haselton, CNBC, 6/8).
    • Mayo Clinic on Thursday announced it is beginning to distribute a test that can identify neutralizing antibodies to the new coronavirus, or the proteins produced after a Covid-19 infection that could help to fight off reinfection. The test will be the first broadly available antibody test that can detect the proteins and determine "what level of protection you actually have," according to Stephen Russel, CEO of Vyriad, which created the test and provided it to Mayo through a licensing partnership with another company (Olson, Star Tribune, 6/12).
    • Microsoft and biotech firm Adaptive Biotechnologies on Thursday launched a database that provides researchers and public health agencies with information about how patients' immune systems respond to the novel coronavirus. The database, called ImmuneCODE, has information about how patients' T-cells responded to the virus during "initial exposure" and after recovery, according to Harland Robins, co-founder and chief scientific officer of Adaptive Biotechnologies. The companies said they will continue to update the database after sequencing more blood samples (Cohen, Modern Healthcare, 6/11).
    • Molina Healthcare last week announced that it will waive out-of-pocket costs testing for the new coronavirus and treatment for Covid-19, the disease caused by the virus, through the end of 2020 for all of its members. The insurer also said it is extending its contract with Teladoc Health to continue to providing no-cost home delivery of prescription drugs and a coronavirus chatbot for its members. The insurer said it also will continue to cover office visits, urgent care, and ED visits related to Covid-19 with no out-of-pocket costs (O'Brien, HealthLeaders Media, 6/8).
    • The National Institute of Allergy and Infectious Diseases (NIAID) on Wednesday confirmed that Moderna's potential vaccine against the new coronavirus is set to enter its final testing stage in July. Vaccine candidates developed by AstraZeneca and Johnson & Johnson will enter their final testing stages in August and September, respectively, officials said (Coleman, The Hill, 6/10;Loftus, Wall Street Journal, 6/10).
    • Regeneron Pharmaceuticals' on Thursday announced an antibody drug cocktail that the company developed to potentially prevent infections from the new coronavirus and treat Covid-19 has entered clinical trials. The drug cocktail is made from two antibodies developed in people who recovered from Covid-19 that research then genetically modified. The company said the treatment could be ready for distribution sooner than a vaccine against the virus if it is proven to be safe and effective (Herman, Axios, 6/11; Sullivan, The Hill, 6/11).
    • Unity Point Health and John Deere have created 1,000 Covid-19 care packages for minority and low-income families in Iowa. The care package includes toilet paper, disinfectant spray, hand sanitizer, paper towels, and instructions about how to use the materials. Daniel Joiner, diversity and community impact officer for Unity Point Health Trinity, said the health system has selected four organizations, including the King Center and World Relief, to distribute the packages to "those who need th[e] resources most" (Trix, WVIK/NPR, 6/8).
    • An international group of scientists led by neuroscientists at Oxford University will study how the Covid-19 pandemic has affected people's sleep habits. The researchers will make data from the study, called the International Covid-19 Sleep Study, available via an international database (Kelland, Reuters, 6/11).
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