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January 29, 2024

Updates from CDC, FDA and Other Agencies

ClinicalDiagnosticsVariants

Publications

Antibody Correlates of Protection for COVID-19 Convalescent Plasma Associated with Reduced Outpatient Hospitalizations

Preprint
Written by Han-Sol Park, Caelan Barranta, Anna Yin, John Lee, Christopher A. Caputo, Maggie Li, Steve Yoon, Ioannis Sitaras, Anne Jedlicka, Yolanda Eby, Malathi Ram, Reinaldo E. Fernandez, Owen R. Baker, Aarthi G. Shenoy, Giselle S. Mosnaim, Yuriko Fukuta, Bela Patel, Sonya L. Heath, Adam C. Levine, Barry R. Meisenberg, Emily S Spivak, Shweta Anjan, Moises A. Huaman, Janis E. Blair, Judith S. Currier, James H. Paxton, Jonathan Gerber, Joann Petrini, Patrick Broderick, William Rausch, MarieElena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie C. Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura L. Hammitt, Catherine G. Sutcliffe, Donald N. Forthal, Martin S. Zand, Edward R. Cachay, Jay S. Raval, Seble G. Kassaye, Christi Marshall, Anusha Yarava, Karen Lane, Nichol A. McBee, Amy Gawad, Nicky Karlens, Atika Singh, Daniel E. Ford, Douglas A. Jabs, Lawrence J. Appel, David M. Shade, Bryan Lau, Stephan Ehrhardt, Sheriza Baksh, Janna R. Shapiro, Jingda Ou, Thomas J. Gniadek, Patrizio Caturegli, Jinke Wu, Nelson Ndahiro, Michael J. Betenbaugh, Alyssa F. Ziman, Daniel F. Hanley, Arturo Casadevall, Shmuel Shoham, Evan M. Bloch, Kelly A. Gebo, Aaron A. R. Tobian, Oliver Laeyendecker, Andrew Pekosz, Sabra L. Klein, David J. Sullivan
April 19, 2023

SARS-CoV-2 antibody levels associated with reduced hospitalization risk remain undefined. Our outpatient COVID-19 convalescent plasma (CCP), placebo-controlled trial observed SARS-CoV-2 antibody levels decreasing 22-fold from matched donor units into post-transfusion…

Significant reduction in the incidence of non-coronavirus infections in patients with chronic lymphocytic leukemia on ibrutinib and venetoclax treatment during the COVID-19 pandemic: An additional benefit of lockdown.

Journal Article
Hematol Oncol
Written by Maria Kislova, Andrei Petrenko, Elena A Dmitrieva, Alexander Milenkin, Konstantin E Nikitin, Vadim V Ptushkin, Alexey V Shabunin, Eugene A Nikitin
April 14, 2023

Effective treatment and prevention of infections challenge management of patients with chronic lymphicytic leukemia (CLL). The COVID-19 pandemic resulted in the reduction of outpatient hospital visits as a part of…

A conceptual model for building program sustainability in public health settings: Learning from the implementation of the program sustainability action planning model and training curricula.

Journal Article
Front Health Serv
Written by Sarah Moreland-Russell, Eliot Jost, Jessica Gannon
March 29, 2023

BACKGROUND: The emergence of implementation science has driven an increase in research examining the implementation of evidence-based programs and policies. However, there has been less attention through program sustainability. To…

The experiences and thoughts of Turkish family physicians about COVID-19 pandemic: A qualitative study.

Journal Article
Eur J Gen Pract
Written by Duygu Ayhan Başer, Pınar Döner Güner, Raziye Şule Gümüştakım, Ezgi Agadayi, Hilal Aksoy, İzzet Fidancı
February 14, 2023

BACKGROUND: Efforts to contain the SARS-CoV-2 virus would fall short without strong primary health care. OBJECTIVES: In this study, we aimed to determine the experiences, views and suggestions of family…

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5–11 Years — United States, October 12–January 1, 2023

article-journal
MMWR. Morbidity and Mortality Weekly Report
Written by Anne M. Hause, Paige Marquez, Bicheng Zhang, John R. Su, Tanya R. Myers, Julianne Gee, Sarada S. Panchanathan, Deborah Thompson, Tom T. Shimabukuro, David K. Shay
January 13, 2023

Vaccination Coverage by Age 24 Months Among Children Born During 2018–2019 — National Immunization Survey–Child, United States, 2019–2021

article-journal
MMWR. Morbidity and Mortality Weekly Report
Written by Holly A. Hill, Michael Chen, Laurie D. Elam-Evans, David Yankey, James A. Singleton
January 13, 2023

Neurological Complications Associated With SARS-CoV-2 Infection: A Single-Centre Experience.

Journal Article
Cureus
Written by Mariana Martins, Ana Pereira, André Teixeira, Diana Lima, Nuno Lopes, Marta Amaral-Silva, Isabel Seixo, Ana Catarina Miguéns
December 18, 2022

BACKGROUND: The clinical presentation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can range from mild or moderate disease (80% of the cases) to severe disease (15%) requiring oxygen…

Council of State and Territorial Epidemiologists/CDC Surveillance Case Definition for Multisystem Inflammatory Syndrome in Children Associated with SARS-CoV-2 Infection — United States

article-journal
MMWR. Recommendations and Reports
Written by Michael Melgar, Ellen H. Lee, Allison D. Miller, Sarah Lim, Catherine M. Brown, Anna R. Yousaf, Laura D. Zambrano, Ermias D. Belay, Shana Godfred-Cato, Joseph Y. Abrams, Matthew E. Oster, Angela P. Campbell
December 16, 2022

Prevalence of SARS-CoV-2 and Influenza Coinfection and Clinical Characteristics Among Children and Adolescents Aged <18 Years Who Were Hospitalized or Died with Influenza — United States, 2021–22 Influenza Season

article-journal
MMWR. Morbidity and Mortality Weekly Report
Written by Katherine Adams, Katie J. Tastad, Stacy Huang, Dawud Ujamaa, Krista Kniss, Charisse Cummings, Arthur Reingold, Jeremy Roland, Elizabeth Austin, Breanna Kawasaki, James Meek, Kimberly Yousey-Hindes, Evan J. Anderson, Kyle P. Openo, Libby Reeg, Lauren Leegwater, Melissa McMahon, Erica Bye, Mayvilynne Poblete, Zachary Landis, Nancy L. Spina, Kerianne Engesser, Nancy M. Bennett, Maria A. Gaitan, Eli Shiltz, Nancy Moran, Melissa Sutton, Nasreen Abdullah, William Schaffner, H. Keipp Talbot, Kristen Olsen, Holly Staten, Christopher A. Taylor, Fiona P. Havers, Carrie Reed, Alicia Budd, Shikha Garg, Alissa O’Halloran, Lynnette Brammer
December 16, 2022

Longitudinal Impact of Social Restrictions on Sexual Health in the Italian Population.

Journal Article
J Sex Med
Written by Francesca Vedovo, Paolo Capogrosso, Lisa Di Blas, Tommaso Cai, Davide Arcaniolo, Salvatore Privitera, Fabrizio Palumbo, Alessandro Palmieri, Carlo Trombetta
June 1, 2022

BACKGROUND: Several trials have reported on the impact of social restrictions due to SARS-CoV-2 (COVID-19) pandemic on sexual function and psycho-physical well-being. However, data showing modifications of these outcomes over…

Phase 1b Open-label, Single Arm, Cohort Dose Escalation Study Evaluating the Safety, Tolerability, and Feasibility of Intervention With AT-100 (rhSP-D) in Intubated Patients Receiving Invasive Mechanical Ventilation With Severe COVID-19 Infection or Respiratory Failure Secondary to Severe Community Acquired Pneumonia

Written by Marc O. Salzberg, MD
December 9, 2020

The purpose of this study is to determine if an investigational drug, AT-100, is safe and tolerated by adults who have severe corona virus disease 2019 (COVID-19) or respiratory failure…

Acute Infection in Mitochondrial Disease: An Observational Prospective Natural History Study of Metabolism, Infection and Immunity

Written by Shannon Kruk, R.N., Eliza M Gordon-Lipkin, M.D., Eliza M Gordon-Lipkin, M.D.
June 9, 2020

Background:

Mitochondrial disease is a rare disorder. It can cause poor growth, developmental delays, muscle weakness, and other symptoms. The disease is usually inherited. It can be present at birth…

Mpox: Development of Drugs and Biological Products; Draft Guidance for Industry; Availability

FDA
Notice of availability
Written by Food and Drug Administration, HHS

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Mpox: Development of Drugs and Biological Products.” FDA is issuing this…