January 8, 2021

Covid-19 roundup: FDA warns Curative coronavirus lab test could return false negatives

Daily Briefing

    Moderna increases its Covid-19 vaccine global production minimum estimate by 100 million doses, CVS and Walgreens announce first round of nursing home vaccinations should be completed by late January, and more.

    • CVS Health and Walgreens on Wednesday both announced that their first round of Covid-19 vaccinations at nursing homes should be completed by Jan. 25. CVS and Walgreens have both partnered with the federal government to administer vaccines to staff and residents of long-term care facilities in 49 states, the District of Columbia, and Puerto Rico. Walgreens said it's working with states on the next phase of vaccination, such as vaccinating other high-priority groups, including people over age 75 and essential workers. CVS said it's in talks with some states "to make a limited number of doses available in the coming weeks in advance of the broader rollout" (Feuer/Repko, CNBC, 1/6).
    • FDA on Monday sent a notice to health care providers and patients that the new lab-based coronavirus test developed by Curative has a risk of providing false negative results if the test isn't "performed in accordance with its authorization or as described in the authorized labeling." The PCR-based test, which received emergency use authorization from FDA in April, is authorized to be used for throat, nasal, or nasopharyngeal swabs, as well as oral fluid specimens to detect the new coronavirus (Modern Healthcare, 1/4).
    • Moderna on Monday announced that expects to produce at least 600 million doses of its Covid-19 vaccine in 2021—an estimate that is up by 20% from its previous global production estimate for the year. Moderna said it expects 100 million doses of the vaccine to be available in the United States by the end of the first quarter of 2021, and 200 million doses to be available by the end of the second quarter. As of now, about 18 million doses have been supplied to the U.S. government, The Hill reports. Separately, Moderna has partnered with Roche to use an antibody test in its vaccine clinical trials to determine how long Moderna's vaccine protects participants from Covid-19. The test can determine whether participants' protection from the vaccine is declining and whether they may need another shot. The tests could also determine if there are any immunity duration differences between different groups of people, MedCity News reports (Higgins-Dunn, CNBC, 1/4; Kelley, The Hill, 1/4; Berg, MedCity News, 12/23/20).
    • The United Kingdom late last year approved for distribution the Covid-19 vaccine developed by AstraZeneca and Oxford University. The vaccine is recommended for adults 18 and older and requires two doses to be administered within four to 12 weeks of each other. The vaccine is less expensive than the mRNA vaccines developed by Pfizer and Moderna and is able to be stored in normal refrigeration. According to Moncef Slaoui, scientific lead for Operation Warp Speed, the United States isn't likely to give AstraZeneca and Oxford's vaccine an emergency use authorization until "somewhere early in the month of April" assuming that "everything goes well" (Irfan, Vox, 12/30/20; Adams, Becker's Hospital Review, 12/30/20).
    • Walgreens is partnering with LabCorp to deliver at-home Covid-19 tests. The tests, called the Pixel by LapCorp Covid-19 Test, which was developed by LabCorp, can be purchased through Walgreens' app and on Walgreens.com. After receiving the tests, patients use a nasal swab to collect a sample and then send the sample to LabCorp for analysis (Anderson, Becker's Hospital Review, 12/28/20).
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