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December 18, 2020

Covid-19 roundup: FDA has authorized the first rapid, at-home coronavirus test

Daily Briefing

    Below we round up the latest news on efforts to combat the Covid-19 epidemic.

    • Two health care workers in Alaska have had adverse reactions to the Covid-19 vaccine developed by Pfizer and BioNTech. One, a middle-aged woman who works at Bartlett Regional Hospital and who has no history of allergies, had an anaphylactic reaction 10 minutes after receiving the vaccine that required hospitalization. The second health care worker experienced eye puffiness, lightheadedness, and a sore throat 10 minutes after the shot. He was sent to the ED, treated with epinephrine, Pepcid, and Benadryl, and was discharged within an hour. According to the hospital, both workers said they did not want their experiences receiving the vaccine to deter others from doing so (Weiland et. al., New York Times, 12/17; Edwards, NBC News, 12/16; Associated Press, 12/17).
    • FDA on Tuesday issued an emergency use authorization (EUA) for the first rapid, at-home Covid-19 test sold over-the-counter. The test, which is developed by Ellume, requires a sample collected by a nasal swab and can produce results within about 15 minutes using a small plastic device that looks similar to a pregnancy test. However, the test requires users to download an app to see their test results that in turn sends data aggregated by Zip codes to regional health officials to ensure that officials can learn about positive results without jeopardizing the user's privacy. The test will be available by January and will cost about $30 (Owens, "Vitals," Axios, 12/16; Wan, Washington Post, 12/15; Stein, "Shots," NPR, 12/15).
    • Pfizer announced it will begin giving its Covid-19 vaccine to participants in the company's vaccine trial who originally received a placebo, effectively unblinding the study. The decision comes even as FDA argues against unblinding studies following an EUA for a vaccine, voicing concerns that drugmakers won't be able to gather important long-term safety and efficacy data. Separately, according to the New York Times, the Trump administration is working on an agreement to help Pfizer source the raw materials it would need to produce "tens of millions" of additional dosages of its Covid-19 vaccine between April and June (Wang, Inside Health Policy, 12/14 [subscription required]; LaFraniere et. al., New York Times, 12/15).
    • Sanofi and GlaxoSmithKline announced their Phase 1/2 trials of their Covid-19 vaccine candidate have shown an "insufficient" immune response in older participants, meaning the launch of the vaccine will be delayed to late 2021. According to Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, the delay is particularly significant because Sanofi is one of the biggest manufacturers of flu vaccines and has the ability to produce vaccines on a large scale. The delay "will impact their ability to [make] the millions of doses that have been pre-ordered because they have to sort out this dose-response effect questions," Ward said (Branswell, STAT News, 12/11; Blamont, Reuters, 12/11; Kirka, Associated Press, 12/11; Rodriguez, USA Today, 12/11).
    • Twitter and Facebook have both announced they will be removing false claims about Covid-19 vaccines on their platforms. In a blog post, Twitter said tweets with false claims suggesting vaccines are "used to intentionally cause harm to or control populations, including statements about vaccines that invoke a deliberate conspiracy" could be removed. Twitter will also add warning labels to tweets with "unsubstantiated rumors, disputed claims, as well as incomplete or out-of-context information" related to vaccines. Meanwhile, Facebook said virus misinformation that could lead to "imminent physical harm" will be removed, potentially including false posts about vaccine safety, efficacy, side effects, or the ingredients in vaccines. "For example, we will remove false claims that Covid-19 vaccines contain microchips, or anything else that isn't on the official vaccine ingredient list," Facebook said (Culliford, Reuters, 12/16; Associated Press, 12/3; Guynn, USA Today, 12/16; Rodrigo, The Hill, 12/3; Bond, NPR, 12/3).

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