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June 9, 2020

Covid-19 roundup: AstraZeneca plans to produce 2B doses of its experimental coronavirus vaccine

Daily Briefing

    The Trump administration identifies five companies most likely to produce a vaccine against the new coronavirus, a study finds no benefits associated with treating Covid-19 patients with the anti-malaria drug hydroxychloroquine, and more.

    • AbbVie on Friday announced that it intends to develop an antibody therapy for the prevention and treatment of Covid-19, the disease caused by the new coronavirus. The drugmaker said it is partnering with Utrecht University, Harbour BioMed, and Erasmus Medical Center to develop the treatment (Chander, Reuters, 6/5).
    • Amazon Web Services and the World Health Organization (WHO) have developed and launched an app aimed at helping health care providers track the global Covid-19 pandemic. The app, which is available through Apple's App Store and Google Play, gives providers access to resources, educational materials, guidance, and tools related to the pandemic (Phelan, Forbes, 6/3).
    • AstraZeneca on Thursday announced partnerships with CEPI, GAVI, and the Serum Institute of India to manufacture and distribute two billion doses of the experimental vaccine against the new coronavirus that the drugmaker is developing with Oxford University. AstraZeneca said it will have 300 million doses of the vaccine candidate manufactured and available by the end of this year. Separately, AstraZeneca on Friday announced that preliminary research shows its blood-cancer drug Calquence helped to ease some severe symptoms of Covid-19 in eight hospitalized patients. The research involved a total of 19 patients, including 11 who had been placed on oxygen and treated with a 10- to 14-day course of Calquence. Eight of those patients could breathe independently afterwards and were discharged after finishing the treatment course, the research showed (Herper, STAT News, 6/4; Talmazan, NBC News, 6/4; Aripaka et al., Reuters, 6/4; Burger, Reuters, 6/5).
    • CDC Director Robert Redfield on Thursday told the House Appropriations Committee's Subcommittee on Labor, Health, and Human Services, Education, and Related Agencies that the agency has developed a new assay that can detect the presence of both the new coronavirus and the influenza virus. Redfield said CDC is seeking an emergency use authorization (EUA) from FDA for the new test (GenomeWeb/Modern Healthcare, 6/5).
    • Fitbit on Wednesday announced that it has received an EUA from FDA for its Fitbit Flow, a ventilator based on the Massachusetts Institute of Technology's E-Vent Design toolbox and Rapidly Manufactured Ventilation Systems. Fitbit developed Fitbit Flow, which is an automatic resuscitator, in collaboration with Oregon Health & Science University and emergency medicine providers at the Mass General Brigham Center for Covid Innovation (Ciaccia, Fox News, 6/4; Mlot, PC Mag, 6/4).
    • HHS on Thursday announced that it is now requiring states to report demographic data for patients who have tested positive for the new coronavirus. Under the new requirements, all laboratories and nonlaboratory facilities offering on-site and in-home testing for the virus must report data on patients' race, ethnicity, age, and sex if the patients test positive for the virus (Weiland/Mandavilli, New York Times, 6/4; Mishra, Reuters, 6/4; Goldstein, Washington Post, 6/4).
    • Novavax on Thursday announced it has entered a deal with the Department of Defense (DOD) under which DOD will provide Novavax with up to $60 million to manufacture the company's experimental vaccine against the new coronavirus. Novavax said, as part of the deal, the company will provide 10 million doses of the experimental vaccine to DOD this year (Shivdas, Reuters, 6/4).
    • Researchers in a study last week published in Cell Systems identified 27 proteins in the blood of Covid-19 patients that could serve as biomarkers to predict how ill a person with the disease will become. According to the researchers, the findings could lead to the development of a test that could inform health care providers whether a Covid-19 patient will develop a severe case of the disease, as well as potential treatments for the disease (Kelland, Reuters, 6/2).
    • Roche on Thursday announced that it has received an EUA from FDA for its Elecsys IL-6 test, which can help identify severe inflammatory responses in Covid-19 patients. Roche said the test also can help to identify Covid-19 patients who may be at high risk of intubation (Neghaiwi/Miller, Reuters, 6/4).
    • Researchers in a study recently published in RECOVERY found that anti-malaria drug hydroxychloroquine showed no benefits for Covid-19 patients. In the study, 1,542 patients in the United Kingdom were treated with hydroxychloroquine, while 3,132 received standard Covid-19 care. After 28 days of treatment, 25.7% of the patients who received hydroxychloroquine had died, compared with 23.5% of patients who received standard Covid-19 care, the study found (Herper, STAT News, 6/5).
    • The Trump administration has identified five companies—Merck, Moderna, Johnson & Johnson, Pfizer, and AstraZeneca, which is working with Oxford University—as the most likely candidates to produce an effective and safe vaccine against the new coronavirus, the New York Times reports. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Moderna's vaccine candidate will enter Phase 3 of clinical trials in July, and the trial will include 30,000 patients. Fauci said he was "cautiously optimistic" that a vaccine against the new coronavirus could prove effective "within a reasonable period of time" (Weiland/Sanger, New York Times, 6/3; Abbott/Loftus, Wall Street Journal, 6/2; Japsen, Forbes, 6/2).
    • The University of Minnesota has released the design for its Coventor alternative ventilator that can be manufactured for $150. In April, the university received an EUA from FDA to use the ventilator in patients with Covid-19. The university last week said its design for Coventor is now available for download at no cost for companies who want to manufacture the device (Whooley, Mass Device, 6/2).
    • WHO on Friday updated its Covid-19 guidance to recommend for the first time that governments ask everyone to wear a face mask or covering in public areas where a risk of transmission of the new coronavirus exists. In the guidance, WHO said face masks and coverings were one of a number of tools that could help to reduce the risk of the virus' transmission, and cautioned wearers against having a false sense of complete protection against the virus due to the masks (Kelland, Reuters, 6/5; Howard, CNN, 6/5).

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