COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic.

Autor: Markowitz LE; National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. Electronic address: lem2@cdc.gov., Hopkins RH Jr; National Vaccine Advisory Committee, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Broder KR; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Lee GM; Stanford University School of Medicine, Stanford, CA, USA., Edwards KM; Vanderbilt University School of Medicine, Nashville, TN, USA., Daley MF; Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA., Jackson LA; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA., Nelson JC; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA., Riley LE; Weill Cornell School of Medicine, New York, NY, USA., McNally VV; Franny Strong Foundation, West Bloomfield, MI, USA., Schechter R; Association of Immunization Managers, California Department of Public Health, Richmond, CA, USA., Whitley-Williams PN; Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA., Cunningham F; Department of Veterans Affairs, Veterans Affairs Center for Medication Safety - Pharmacy Benefit Management Services, Hines, IL, USA., Clark M; Indian Health Service (IHS), IHS National Pharmacy & Therapeutics Committee, Anchorage, AK, USA., Ryan M; Defense Health Agency, Immunization Healthcare Division, San Diego, CA, USA., Farizo KM; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Wong HL; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kelman J; Centers for Medicare & Medicaid Services, Baltimore, MD, USA., Beresnev T; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA., Marshall V; Office of the Assistant Secretary for Health, Department of Health and Human Services, Washington, DC, USA., Shay DK; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Gee J; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Woo J; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., McNeil MM; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Su JR; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Shimabukuro TT; Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA., Wharton M; National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA., Keipp Talbot H; Vanderbilt University School of Medicine, Nashville, TN, USA.

Publikováno v: Vaccine [Vaccine] 2024 Feb 09. Date of Electronic Publication: 2024 Feb 09.

Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study.

Autor: Dayan GH; Sanofi, Swiftwater, PA, USA., Rouphael N; Hope Clinic, Emory University, Atlanta, GA, USA., Walsh SR; Harvard Medical School, Boston, MA, USA., Chen A; Sanofi, Swiftwater, PA, USA., Grunenberg N; Fred Hutchinson Cancer Center, Seattle, WA, USA., Allen M; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MD, USA., Antony J; Sanofi, Frankfurt, Germany., Bhate AS; Jeevan Rekha Hospital, Belgavi, India., Beresnev T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MD, USA., Bonaparte MI; Sanofi, Swiftwater, PA, USA., Celle M; Sanofi, Marcy l'Etoile, France., Ceregido MA; GSK, Wavre, Belgium., Corey L; Fred Hutchinson Cancer Center, Seattle, WA, USA., Fu B; Sanofi, Swiftwater, PA, USA., Grillet MH; Sanofi, Lyon, France., Keshtkar-Jahromi M; National Institute of Health, Rockville, MD, USA.; John Hopkins University School of Medicine, Baltimore, MD, USA., Juraska M; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kee JJ; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kaali S; Research and Development Division, Ghana Health Service, Kintampo North Municipality, Ghana., Koutsoukos M; GSK, Wavre, Belgium., Masotti R; Sanofi, Swiftwater, PA, USA., Michael NL; Walter Reed Army Institute of Research, MD, USA., Neuzil KM; University of Maryland School of Medicine, Baltimore, MD, USA., Reynales H; Centro de Attencion e Investigation Medica S.A.S. - Caimed Chía, Chía, Colombia., Robb ML; The Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MA, USA., Uchiyama A; Medical Corporation Asbo Tokyo Asbo Clinic, Tokyo, Japan., Sawe F; Kenya Medical Research Institute - US Army Medical Research, Kisumu, Kenya., Schuerman L; GSK, Wavre, Belgium., Shrestha R; Center for Clinical Trial Studies, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Nepal., Tong T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MD, USA., Treanor J; Department of Health and Human Services (HHS), Tunnell Government Services in Support of Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), Washington, DC, USA., Diazgranados CA; Sanofi, Swiftwater, PA, USA., Chicz RM; Sanofi, Waltham, MA, USA., Gurunathan S; Sanofi, Swiftwater, PA, USA., Savarino S; Sanofi, Swiftwater, PA, USA., Sridhar S; Sanofi, Reading, UK.

Publikováno v: EClinicalMedicine [EClinicalMedicine] 2023 Sep 12; Vol. 64, pp. 102168. Date of Electronic Publication: 2023 Sep 12 (Print Publication: 2023).

Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.

Autor: Ortega-Villa AM; Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA., Hynes NA; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Levine CB; Division of Infectious Disease, Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas, USA., Yang K; Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA., Wiley Z; Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Jilg N; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.; Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA., Wang J; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA., Whitaker JA; Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA., Colombo CJ; Department of Virtual Health and Department of Medicine, Madigan Army Medical Center, Tacoma, Washington, USA.; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA., Nayak SU; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Kim HJ; Department of Community Health Systems, School of Nursing, University of California, San Francisco, San Francisco, California, USA.; National Patient Care Services, Kaiser Permanente, Oakland, California, USA., Iovine NM; Division of Infectious Diseases and Global Medicine, Department of Medicine, University of Florida Health, Gainesville, Florida, USA., Ince D; Division of Infectious Diseases, Department of Internal Medicine, University of Iowa, Iowa City, Iowa, USA., Cohen SH; Division of Infectious Diseases, University of California, Davis, Sacramento, California, USA., Langer AJ; COVID-19 Emergency Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Wortham JM; COVID-19-Associated Hospitalization Surveillance Network, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Atmar RL; Department of Medicine, Baylor College of Medicine, Houston, Texas, USA., El Sahly HM; Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA., Jain MK; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA., Mehta AK; Division of Infection Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.; National Emerging Special Pathogens Treatment and Education Center, Atlanta, Georgia, USA., Wolfe CR; Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA., Gomez CA; Division of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA., Beresnev T; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Mularski RA; Department of Pulmonary and Critical Care Medicine, Northwest Permanente, Kaiser Permanente Northwest, Portland, Oregon, USA.; The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA., Paules CI; Division of Infectious Diseases, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA., Kalil AC; Division of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA., Branche AR; Division of Infectious Diseases, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA., Luetkemeyer A; Department of Medicine, University of California, San Francisco, San Francisco, California, USA., Zingman BS; Department of Medicine, Montefiore Medical Center, University Hospital for Albert Einstein College of Medicine, Bronx, New York, USA., Voell J; Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Whitaker M; COVID-19-Associated Hospitalization Surveillance Network, Centers for Disease Control and Prevention, Atlanta, Georgia, USA., Harkins MS; Division of Pulmonary and Critical Care, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA., Davey RT Jr; Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Grossberg R; Division of Infectious Diseases, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA., George SL; Department of Internal Medicine, Saint Louis University and St Louis Veterans Affairs Medical Center, St Louis, Missouri, USA., Tapson V; Division of Pulmonary and Critical Care, Cedars-Sinai Medical Center, Los Angeles, California, USA., Short WR; Division of Infectious Diseases, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Ghazaryan V; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Benson CA; Division of Infectious Diseases and Global Public Health, University of California, San Diego, San Diego, California, USA., Dodd LE; Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA., Sweeney DA; Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of California, San Diego, San Diego, California, USA., Tomashek KM; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.

Publikováno v: Open forum infectious diseases [Open Forum Infect Dis] 2023 May 27; Vol. 10 (6), pp. ofad290. Date of Electronic Publication: 2023 May 27 (Print Publication: 2023).

Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine.

Autor: Dayan GH; Sanofi, Swiftwater, PA, USA., Rouphael N; Emory University Hop eClininc, Atlanta, GA, USA., Walsh SR; Harvard Medical School, Boston, MA, USA., Chen A; Sanofi, Swiftwater, PA, USA., Grunenberg N; Fred Hutchinson Cancer Center, Seattle, WA, USA., Allen M; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MA, USA., Antony J; Sanofi, Frankfurt, Germany., Asante KP; Research and Development Division, Ghana Health Service, Kintampo North Municipality, Ghana., Bhate AS; Jeevan Rekha Hospital, Belgavi, India., Beresnev T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MA, USA., Bonaparte MI; Sanofi, Swiftwater, PA, USA., Ceregido MA; GSK, Wavre, Belgium., Dobrianskyi D; Medical Centre, Medical Clinic Blagomed LLC, Kyiv, Ukraine., Fu B; Sanofi, Swiftwater, PA, USA., Grillet MH; Sanofi, Lyon, France., Keshtkar-Jahromi M; National Institute of Health, Rockville, Maryland.; John Hopkins University School of Medicine, Baltimore, Maryland., Juraska M; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kee JJ; Fred Hutchinson Cancer Center, Seattle, WA, USA., Kibuuka H; Makerere University Walter Reed Project, Kampala, Uganda., Koutsoukos M; GSK, Wavre, Belgium., Masotti R; Sanofi, Swiftwater, PA, USA., Michael NL; Walter Reed Army Institute of Research, MD, USA., Reynales H; Centro de Attencion e Investigation Medica S.A.S. - Caimed Chía, Chía, Colombia., Robb ML; The Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MA, USA., Villagómez Martínez SM; Hospital de Temixco en acuerdo con el Instituto Nacional de Pediatria, México., Sawe F; Kenya Medical Research Institute - US Army Medical Research, Kisumu, Kenya., Schuerman L; GSK, Wavre, Belgium., Tong T; National Institute of Allergy and Infectious Diseases / National Institutes of Health, Bethedsa, MA, USA., Treanor J; Tunnell Government Services in support of Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC, USA., Wartel TA; International Vaccine Institute, Seoul, South Korea., Diazgranados CA; Sanofi, Swiftwater, PA, USA., Chicz RM; Sanofi, Cambridge, MA, USA., Gurunathan S; Sanofi, Swiftwater, PA, USA., Savarino S; Sanofi, Swiftwater, PA, USA., Sridhar S; Sanofi, Reading, UK.

Publikováno v: MedRxiv : the preprint server for health sciences [medRxiv] 2023 Jan 13. Date of Electronic Publication: 2023 Jan 13.

Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Autor: Wolfe CR; Duke University, Durham, NC, USA., Tomashek KM; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Patterson TF; University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio, TX, USA., Gomez CA; University of Utah, Salt Lake City, UT, USA., Marconi VC; Emory University, Atlanta, GA, USA., Jain MK; University of Texas Southwestern and Parkland Health and Hospital System, Dallas, TX, USA., Yang OO; University of California, Los Angeles, CA, USA., Paules CI; Pennsylvania State Health Milton S Hershey Medical Center, Hershey, PA, USA., Palacios GMR; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Grossberg R; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA., Harkins MS; University of New Mexico Health Sciences Center, Albuquerque, NM, USA., Mularski RA; Kaiser Permanente Northwest, Portland, OR, USA., Erdmann N; University of Alabama at Birmingham, Birmingham, AL, USA., Sandkovsky U; Baylor University Medical Center, Dallas, TX, USA., Almasri E; University of California, San Francisco, CA, USA., Pineda JR; Instituto Nacional de Enfermedades Respiratorias (INER), Mexico City, Mexico., Dretler AW; Infectious Disease Specialists of Atlanta and Emory Decatur Hospital, Decatur, GA, USA., de Castilla DL; Evergreen Health Medical Center, Kirkland, WA, USA., Branche AR; University of Rochester Medical Center, Rochester, NY, USA., Park PK; University of Michigan, Ann Arbor, MI, USA., Mehta AK; Emory University, Atlanta, GA, USA., Short WR; The University of Pennsylvania, Philadelphia, PA, USA., McLellan SLF; The University of Texas Medical Branch, Galveston, TX, USA., Kline S; The University of Minnesota Medical School, Minneapolis, MN, USA., Iovine NM; University of Florida Health, Shands Hospital, Gainesville, FL, USA., El Sahly HM; Baylor College of Medicine, Houston, TX, USA., Doernberg SB; University of California, San Francisco, CA, USA., Oh MD; Seoul National University Hospital, Seoul, South Korea., Huprikar N; Walter Reed National Military Medical Center, Bethesda, MD, USA., Hohmann E; Massachusetts General Hospital, Boston, MA, USA., Kelley CF; Grady Memorial Hospital, Atlanta, GA, USA., Holodniy M; VA Palo Alto Health Care System, Palo Alto, CA, USA., Kim ES; Seoul National University Bundang Hospital, Seongnam, South Korea., Sweeney DA; University of California, San Diego, La Jolla, CA, USA., Finberg RW; University of Massachusetts Medical School, Worcester, MA, USA., Grimes KA; Houston Methodist Hospital, Houston, TX, USA., Maves RC; Naval Medical Center, San Diego, CA, USA., Ko ER; Duke University, Durham, NC, USA., Engemann JJ; Duke University, Durham, NC, USA., Taylor BS; University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio, TX, USA., Ponce PO; University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio, TX, USA., Larson L; University of Nebraska Medical Center, Omaha, NE, USA., Melendez DP; University of Utah, Salt Lake City, UT, USA., Seibert AM; University of Utah, Salt Lake City, UT, USA., Rouphael NG; Emory University, Atlanta, GA, USA., Strebe J; University of Texas Southwestern and Parkland Health and Hospital System, Dallas, TX, USA., Clark JL; University of California, Los Angeles, CA, USA., Julian KG; Pennsylvania State Health Milton S Hershey Medical Center, Hershey, PA, USA., de Leon AP; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Cardoso A; Eli Lilly, Indianapolis, IN, USA., de Bono S; Eli Lilly, Indianapolis, IN, USA., Atmar RL; Baylor College of Medicine, Houston, TX, USA., Ganesan A; Walter Reed National Military Medical Center, Bethesda, MD, USA., Ferreira JL; The Emmes Company, LLC, Rockville, MD, USA., Green M; The Emmes Company, LLC, Rockville, MD, USA., Makowski M; The Emmes Company, LLC, Rockville, MD, USA., Bonnett T; Clinical Monitoring Research Program Directorate, Frederick National Laboratory, Frederick, MD, USA., Beresnev T; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Ghazaryan V; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Dempsey W; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Nayak SU; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Dodd LE; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Beigel JH; The National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Kalil AC; University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: akalil@unmc.edu.

Publikováno v: The Lancet. Respiratory medicine [Lancet Respir Med] 2022 Sep; Vol. 10 (9), pp. 888-899. Date of Electronic Publication: 2022 May 23.