Tag: FDA

FDA panel split on COVID-19 vaccines for children

Editor's Note Members of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee during a June 10 meeting were split on whether COVID-19 vaccines should be granted emergency use authorization (EUA) for children under 12 years of age, the June 11 Regulatory Focus reports. Some members…

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By: Judy Mathias
June 15, 2021
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FDA: Class I recall of Innova Medical Group’s COVID-19 test

Editor's Note The Food and Drug Administration (FDA), on June 10, announced the Class I recall of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test. The test, which claimed to determine if a person has an active COVID-19 infection, has not been authorized, cleared, or approved by the FDA for…

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By: Judy Mathias
June 14, 2021
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Cleveland Clinic study finds no vaccine needed for those previously infected with COVID-19

Editor's Note This study by researchers at the Cleveland Clinic finds that those who have been infected with COVID-19 do not get additional benefits from the vaccine, suggesting that vaccines should be prioritized to individuals who have not gotten the infection. During this analysis of 52,238 Cleveland Clinic employees over…

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By: Judy Mathias
June 10, 2021
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University of Maryland Medical System to require employees to get COVID-19 vaccinations

Editor's Note The University of Maryland Medical System (UMMS) announced on June 9 that it will require COVID-19 vaccinations for all employees, beginning September 1, 2021. UMMS leaders at the manager level and above have until August 1, 2021, to be vaccinated. All UMMS team members and partners, including contractors,…

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By: Judy Mathias
June 10, 2021
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CDC: Decreases in COVID-19 cases, ED visits, admissions, deaths, since vaccinations began

Editor's Note This study by researchers from the Centers for Disease Control and Prevention (CDC) finds that since adult COVID-19 vaccinations began in the US in December 2020, there has been a: 40% decline in cases 59% decrease in emergency department (ED) visits 65% drop in hospital admissions 66% decline…

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By: Judy Mathias
June 9, 2021
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Public trust, willingness to vaccinate against COVID-19

Editor's Note This study by researchers in the United Kingdom finds that despite declines in hesitancy to be vaccinated against COVID-19, vaccine hesitancy remains high in young adults and Black and low socioeconomic status individuals. A total of 7,420 participants provided 42,154 survey responses to the Understanding America Study (UAS)…

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By: Judy Mathias
May 27, 2021
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FDA clears single-use flexible cystoscope from UroViu

Editor's Note UroViu Corporation, Bellevue, Washington, announced May 24 that it has received clearance from the Food and Drug Administration (FDA) for its portable, flexible single-use cystoscope. The Uro-G has a fully deflectable tip that enables physicians to perform interventional and diagnostic urologic procedures in various settings, without reprocessing.

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By: Judy Mathias
May 27, 2021
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CDC: COVID-19 vaccine breakthrough infections

Editor's Note Of 101 million Americans vaccinated against COVID-19 as of April 30, 2021, more than 10,200 had breakthrough infections 14 days or more after receipt of all vaccine doses, according to the Centers for Disease Control and Prevention (CDC). Among these cases: 63% occurred in women 27% were asymptomatic…

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By: Judy Mathias
May 26, 2021
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New COVID-19 cases down 57%

Editor's Note The 7-day average for new COVID-19 cases in the US is down 57%, and COVID-19-related deaths dropped 23%, compared to a month ago, according to Johns Hopkins University. Nearly half (49.6%) of adults have been fully vaccinated.

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By: Judy Mathias
May 26, 2021
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Survey: HCWs report concerns about unsafe working conditions during COVID-19

Editor's Note The George Washington University Milken Institute School of Public Health, in Washington, DC, released a report on May 25 that summarizes findings from a national survey of frontline healthcare workers (HCWs) during the COVID-19 pandemic. The survey of 1,200 HCWs from all 50 states and the District of…

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By: Judy Mathias
May 25, 2021
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