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Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFThe omicron variant of SARS-CoV-2 drove broadly increased seroprevalence in a public university setting.
PLOS Glob Public Health
January 2025
Virginia G. Piper Center for Personalized Diagnostics, Biodesign Institute, Arizona State University, Tempe, Arizona, United States of America.
Omicron is the comparatively most transmissible and contagious variant of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). We conducted a seroprevalence study from March 1-3, 2022, to investigate the seroprevalence of SARS-CoV-2 antibodies among individuals aged 18 years and older after the Omicron outbreak. The seroprevalence of anti-receptor binding domain (RBD) antibodies was found to be 96.
View Article and Find Full Text PDFBVA President Liz Mullineaux reflects on a busy 2024 and looks to the year ahead.
View Article and Find Full Text PDFPoison, lies, war: A mixed methods content analysis of posts about COVID-19 vaccination on Gab Social.
Hum Vaccin Immunother
December 2025
Communication Department, California State Polytechnic University, Pomona, CA, USA.
Recent surges in COVID-19 cases demonstrate the unabated transmissibility of this disease. Despite the ongoing threat of contagion, however, uptake of the COVID-19 vaccines, especially as booster doses, remains suboptimal among eligible adults and children in the United States, as reported by the World Health Organization (WHO). Public attitudes toward these vaccines remain balkanized, with some groups harboring ambivalence or even opposition to receiving inoculation.
View Article and Find Full Text PDFDual Inhibitors of SARS-CoV-2 3CL Protease and Human Cathepsin L Containing Glutamine Isosteres Are Anti-CoV-2 Agents.
J Am Chem Soc
January 2025
Department of Biochemistry and Biophysics, Texas A&M University, 301 Old Main Drive, College Station, Texas 77845, United States.
SARS-CoV-2 3CL protease (Main protease) and human cathepsin L are proteases that play unique roles in the infection of human cells by SARS-CoV-2, the causative agent of COVID-19. Both proteases recognize leucine and other hydrophobic amino acids at the P position of a peptidomimetic inhibitor. At the P position, cathepsin L accepts many amino acid side chains, with a partial preference for phenylalanine, while 3CL-PR protease has a stringent specificity for glutamine or glutamine analogues.
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