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February 11, 2022

Covid-19 roundup: FDA recalls illegally imported at-home test kits

Daily Briefing

    FDA fully approves Moderna's Covid-19 vaccine, a study finds moderate-to-severe Covid-19 increases the risk of complications in pregnant individuals, and more in this week's roundup of Covid-19 news.

    • Johnson & Johnson (J&J) has temporarily halted production of its Covid-19 vaccine at its facility in Leiden, Netherlands, the New York Times reports. J&J's vaccine, which does not require ultracold refrigeration, has been the Covid-19 vaccine of choice for many developing countries. According to the Times, the company's decision came as a surprise to two of its major customers: the African Union and Covax, an organization that helps deliver Covid-19 to poor countries. However, Jake Sargent, a J&J spokesperson, said the company had millions of finished vaccine doses in inventory to fulfill its commitment and that it was "focused on ensuring [its] vaccine is available where people are in need." (Robbins et al., New York Times, 2/8)
    • FDA last week fully approved Moderna's mRNA Covid-19 vaccine, which will now be marketed as Spikevax. It is the second Covid-19 vaccine to gain full approval, as Pfizer-BioNTech's vaccine was approved in August 2021. "The public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness, and manufacturing quality required of any vaccine approved for use in the United States," said acting FDA Commissioner Janet Woodcock. Shortly after, CDC's Advisory Committee on Immunization Practices (ACIP) unanimously backed FDA's approval of Moderna's vaccine in a 13-0 vote. CDC Director Rochelle Walensky then endorsed the decision, fully recommending Moderna's primary two-dose series for individuals ages 18 and older. (Knutson, Axios, 1/31; AP/Modern Healthcare, 1/31; Lou, MedPage Today, 2/4)
    • The brains of patients who died of Covid-19 had similar pathological changes seen in patients with Alzheimer's disease, according a small study published in Alzheimer's & Dementia. For the study, researchers analyzed autopsies of 10 patients who died of Covid-19. They found that an inflammatory response from coronavirus infection was associated with pathways causing tau hyperphosphorylation typically seen in individuals with Alzheimer's disease. "The study shows that long Covid-19 brain fog may be a form of Alzheimer's disease, but more research needs to be done before we can make definitive conclusions," said Andrew Marks, a researcher at Columbia University and one of the study's authors. In addition, the researchers found that defective ryanodine receptors may be behind some of the neurological changes seen in Covid-19 patients. According to the researchers, targeting these defective receptors may be a way to alleviate some of the negative cognitive effects of Covid-19 and long Covid. "Future experiments will explore calcium channels as a potential therapeutic target for the neurological complications associated with Covid-19," the authors wrote. (George, MedPage Today, 2/4)
    • A new large-scale study published in JAMA Network Open sheds new light on the potential symptoms of long Covid, Healthcare IT News reports. For the study, researchers from CDC and the Louisiana Public Health Institute examined aggregated EHR data from more than 2 million patients who tested positive for Covid-19 between March and December 2020 and had medical encounters between 31 and 150 days after testing. Overall, the researchers found that shortness of breath, fatigue, and type 2 diabetes were more prevalent for patients who had tested positive and been hospitalized, which suggests long-term symptoms may be more common with severe Covid-19 infections. Although the researchers could not determine whether new conditions, such as type 2 diabetes, were the result of Covid-19, they encouraged health care providers to continue monitoring Covid-19 patients for symptoms. "These estimates highlight the need for health care professionals and patients to monitor for development of new symptoms and conditions beyond the first month after SARS-CoV-2 infection, particularly for individuals who require hospitalization for acute Covid-19," the researchers wrote. (Jercich, Healthcare IT News, 2/7)
    • FDA last week recalled unauthorized at-home Covid-19 test kits that had been illegally imported into the United States, Becker's Hospital Review reports. SD Biosensor, a South Korean diagnostics company, said there was no known distribution of its Standard Q Covid-19 At Home Tests directly to consumers but issued a recall "out of an abundance of caution." Currently, the company said it is "taking appropriate measures to prevent further attempts at illegal importation of unauthorized tests by strengthening contract terms and their enforcement with its distributors." FDA recommends people discard and avoid use of the test if they encounter it and that anyone who has used the test consider retesting themselves with an FDA-authorized test. (Gleeson, Becker's Hospital Review, 2/9; Lagasse, Healthcare Finance News, 2/9)
    • Pregnant patients with moderate-to-severe Covid-19 are more likely to experience pregnancy complications, according to a new study published in JAMA. For the study, researchers analyzed about 14,000 pregnant individuals who gave birth between March 1 and December 20, 2020, before Covid-19 vaccines were available. Among the participants, around 2,400 were infected with Covid-19 during their pregnancies. Overall, the researchers found that pregnant patients with moderate-to-severe Covid-19 were more likely to experience complications, such as serious illness or obstetric issues, compared with uninfected patients (26.1% vs 9.2%, respectively). Specifically, almost 27% of patients with moderate-to-severe Covid-19 had a preterm birth compared with 14.1% of uninfected patients. Infected patients were also more likely to have fetal or newborn death (3.4%) compared with uninfected patients (1.8%). However, more mild or asymptomatic Covid-19 cases were not associated with increased pregnancy risks. "The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected with SARS-CoV-2," said Diana Bianchi, director of the National Institute of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study. "This is the best way to protect pregnant women and their babies." (Carbajal, Becker's Hospital Review, 2/7; Metz et al., JAMA, 2/7)

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