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August 24, 2020

Covid-19 roundup: Trump admin to allow lab-developed coronavirus tests to skip FDA review

Daily Briefing
    • HHS in a notice published Wednesday announced that the Trump administration will allow lab-developed tests (LDTs), including those for the novel coronavirus, to be put on the market without FDA review. The new policy does not apply to tests developed by device manufacturers, who are still required to obtain FDA approval to put their products on the market. Officials said HHS based the policy on a determination that FDA does not have the authority to regulate LDTs of any kind. "They did not gain the authority to regulate LDTs by having gone through a notice and comment rulemaking period, which would be required for an assertion of authority like that," one official said. However, some health experts are concerned the new policy will result in the release of faulty or inaccurate coronavirus tests, Politico reports (Lim/Brennan, Politico, 8/19; McGinley/Abutaleb, Washington Post, 8/20).

    • Brigham and Women's Hospital will partner with the startup Rose to launch a pilot project intended to support the mental health of the hospital's clinicians during the coronavirus epidemic. The pilot will give emergency health care professionals at the hospital access to the Rose app, which uses artificial intelligence to track symptoms of potential mental health conditions. Users will complete questionnaires and free-response journal entries via the app, which then uses the data to monitor users' mental health and stress levels. According to Rose, the technology can detect early warning signs of mental health conditions such as depression, trauma, and anxiety (Landi, FierceHealthcare, 8/19; McGinley/Abutaleb, Washington Post, 8/20).

    • FDA has issued an emergency use authorization for a test for the novel coronavirus developed by the University of Illinois. Scientists at the school developed the saliva-based test, which is already in use at the university, to test faculty, staff, and students before the university's reopening, according to university Chancellor Robert Jones. University of Illinois system President Tim Killeen said the tests, which cost $10 each, will be "a real game-changer" by providing "fast and efficient results" (Asplund, Modern Healthcare, 8/19).

    • Fitbit on Wednesday shared results from its ongoing Covid-19 study showing the wearables can identify about 50% of people infected with the coronavirus up to one day before they begin to exhibit symptoms of Covid-19, the disease caused by the virus. According to the data, increases in resting heart and breathing rate were occasionally detected about one week before the participants started reporting symptoms of the disease. The study also found that fatigue was the most commonly reported symptom of Covid-19, while shortness of breath and vomiting were the symptoms most likely to precede hospitalization. The study, which Fitbit launched in May, has enrolled more than 100,000 Fitbit wearers and, so far, 1,000 positive coronavirus cases have been reported among the cohort (Drees, Becker's Hospital Review, 8/19; Heneghan, Fitbit release, 8/19).

    • A study published this month, which has not yet been peer-reviewed, found that coronavirus antibodies may protect against infection. According to the study, more than 100 crew members on a ship called the American Dynasty became infected by the novel coronavirus over the course of 18 days at sea—but three of the crew members, who had carried antibodies against the infection before boarding the ship, never contracted the virus while onboard. The study results could imply that an immune response to the virus might protect against reinfection, the New York Times reports (Mandavilli, New York Times, 8/19).

    • Johnson & Johnson on Thursday announced plans to begin a Phase 3 trial for its coronavirus vaccine candidate in September. The trial would enroll up to 60,000 participants across 180 locations in the United States and other countries, making it the largest late-stage trial for a coronavirus vaccine candidate announced to date. The study will randomly select participants to receive the vaccine candidate or a placebo and will then follow the participants for more than two years. Johnson & Johnson spokesperson Jake Sargent said the company plans to conduct the trial in locations with high incidence rates of Covid-19 (Lovelace, CNBC, 8/20; Loftus, Wall Street Journal, 8/20; Mishra/O'Donnell, Reuters, 8/20).

    • A study published in Health Affairs Thursday found one in five nursing homes experienced severe shortages of personal protective equipment (PPE) from May to July, despite pledges from the Trump administration to help nursing homes secure PPE during that time. The researchers found that, between May and July, 20.7% of U.S. nursing homes reported a severe shortage of PPE, meaning they had a week or less of PPE in supply. The researchers also found there was little to no change in the proportion of facilities reporting severe PPE shortages later that summer, with 19.1% reporting severe shortages between late June and mid-July. The study also revealed that one in five nursing homes experienced staffing shortages during this time, with no improvement between early and late summer (Alonso-Zaldivar, Associated Press, 8/20).

    • Pfizer and BioNTech on Thursday posted results from an early trial testing two vaccine candidates and found that, while both candidates generated a similar immune response, the second candidate resulted in fewer side effects. The first vaccine candidate, called B1, generated adverse events in patients ages 18 to 55 50% of the time and generated adverse events in patients ages 65 to 85 almost 17% of the time. In comparison, the other candidate, called B2, generated adverse events in patients ages 18 to 55 almost 17% of the time, with no adverse events reported in patients older than 65. The companies said that, due to the results, they plan to conduct a large-scale, 30,000-patient clinical trial on B2. "Obviously, the better tolerated the vaccine, the more I think it will encourage public acceptance of a broad immunization," said William Gruber, SVP of vaccine clinical research and development at Pfizer (Herper, STAT News, 8/20).

    • The federal government has awarded Duke University researchers $7.6 million to develop a coronavirus vaccine based on antibodies to the pathogen. Duke researchers are now looking to start a Phase I trial of the experimental vaccine, which uses "highly potent antibodies" from recovered coronavirus patients. The University of North Carolina and Duke University researchers said they are looking for 500 people to test the potential vaccine in the trial, which researchers plan to conduct in the coming months. The researchers said they are aiming to enroll people who are at high risk for developing Covid-19, including people of color or people who live in areas with a high incidence of the disease (Gulledge, Triangle Business Journal, 8/20; Stradling, News Observer, 8/20).

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