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Covid-19 roundup: FDA recalls millions of at-home Covid-19 tests over false positives


Researchers have identified a gene that makes people more likely to experience respiratory complications from Covid-19, people with certain sleep disorders may have a higher risk of hospitalization and death from Covid-19, and more in this week's roundup of Covid-19 news.

  • Researchers from the University of Oxford have identified a gene that makes people more likely to experience respiratory complications from Covid-19, Bloomberg reports. The gene, which is known as LZTFL1, doubles a person's risk of respiratory failure if they are infected with the coronavirus. In addition, a higher-risk version of the gene likely prevents cells lining airways and the lungs from responding properly to Covid-19. The findings, which were published in Nature, "[show] that the way in which the lung responds to the infection is critical," said James Davies, co-lead author of the study and an associate professor of genomics at Oxford. "This is important because most treatments have focused on changing the way in which the immune system reacts to the virus." He added, "If you have the higher-risk genotype and you get very unwell with Covid, there's a 50% chance that that wouldn't have happened to you had you had the lower-risk genotype." The researchers also found that the gene is disproportionately found in certain ethnic groups. Specifically, the gene is found in 60% of people with South Asian ancestry, compared with 15% of people with European ancestry and 2% of people with Afro-Caribbean ancestry. According to Bloomberg, this genetic difference may have contributed to higher rates of hospitalizations and deaths from Covid-19 in certain communities or regions, such as the Indian subcontinent. (Ring, Bloomberg, 11/4; Polus, The Hill, 11/4)
  • FDA on Tuesday expanded a recall of at-home Covid-19 test kits manufactured by Ellume, a biotechnology company based in Australia. In total, the recall affects around 3.5 million Covid-19 test kits, two million of which were newly identified, the New York Times reports. According to FDA, the affected test kits may produce "false positives" due to a manufacturing defect. The recall, which was initially announced last month, is a Class I recall, the most serious type, and FDA said using the tests could lead to "serious adverse health consequences." In a statement, an Ellume representative said the company has "investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S." FDA indicated it will monitor the company's corrective efforts to ensure the problem will not recur, NPR reports. (Anthes, New York Times, 11/11; Mistich, NPR, 11/11)
  • According to the World Health Organization (WHO), Europe saw a 7% increase in new Covid-19 cases last week, making it the only region to see a rise in new cases. Of the 3.1 million new Covid-19 cases reported globally last week, around two-thirds occurred in Europe, the New York Times reports. Russia, Britain, and Turkey reported the highest numbers of new infections. At the same time, Europe experienced a 10% increase in Covid-19 deaths, accounting for over half of the 48,000 Covid-19 deaths reported worldwide. According to the Times, officials in hard-hit countries are considering implementing new restrictions to limit further outbreaks as winter approaches. (Kwai, New York Times, 11/11; Lonas, The Hill, 10/20)
  • Ocugen last week submitted an application for emergency use authorization (EUA) of its Covid-19 vaccine candidate to FDA for use in children ages two to 18, Philadelphia Business Journal reports. The vaccine candidate, which is known outside of the United States as Covaxin, was developed by Bharat Biotech, and has been authorized for emergency use by WHO. According to Ocugen co-founder and CEO Shankar Musunuri, filing for a pediatric EUA of the vaccine in the United States is a "significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic." He added, "Having a new type of vaccine available will enable people to discuss with their child's physician the best approach for them to lower their child's risk of contracting Covid-19." (George, Philadelphia Business Journal, 11/5)
  • People with certain sleep disorders have an increased risk of hospitalization and death from Covid-19, according to a new Cleveland Clinic study. For the study, researchers used Cleveland Clinic's Covid-19 research registry to identify 5,400 patients who had an available sleep study record and had been tested for Covid-19. After accounting for comorbidities, such as obesity and heart and lung disease, the researchers found that patients with sleep-disordered breathing and sleep-related hypoxia had more severe Covid-19 outcomes, including a 31% higher risk of hospitalization and death from the disease. "As the Covid-19 pandemic continues and the disease remains highly variable from patient to patient, it is critical to improve our ability to predict who will have more severe illness so that we can appropriately allocate resources," said Reena Mehra, director of sleep disorder research at Cleveland Clinic and one of the study's authors. "This study improved our understanding of the association between sleep disorders and the risk for adverse Covid-19 outcomes. It suggests biomarkers of inflammation may mediate this relationship." (Carbajal, Becker's Hospital Review, 11/10)

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