Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial

• Published in: PLoS medicine Vol. 19; no. 6; p. e1004024
• Main Authors: Takuva, Simbarashe, Takalani, Azwidhwi, Seocharan, Ishen, Yende-Zuma, Nonhlanhla, Reddy, Tarylee, Engelbrecht, Imke, Faesen, Mark, Khuto, Kentse, Whyte, Carmen, Bailey, Veronique, Trivella, Valentina, Peter, Jonathan, Opie, Jessica, Louw, Vernon, Rowji, Pradeep, Jacobson, Barry, Groenewald, Pamela, Dorrington, Rob E., Laubscher, Ria, Bradshaw, Debbie, Moultrie, Harry, Fairall, Lara, Sanne, Ian, Gail-Bekker, Linda, Gray, Glenda, Goga, Ameena, Garrett, Nigel
• Format: Journal Article
• Language: English
• Published: San Francisco Public Library of Science 01.06.2022; Public Library of Science (PLoS)
• Subjects: Age; Biology and Life Sciences; Clinical trials; Collaboration; Confidence intervals; Consent; Coronaviruses; COVID-19; COVID-19 vaccines; Disease prevention; Fever; Guillain-Barre syndrome; Health care; Immune system; Immunization; Infectious diseases; Laboratories; Medical personnel; Medical records; Medicine and Health Sciences; Morbidity; Nervous system; People and places; Research and Analysis Methods; Safety; Surveillance; Thrombocytopenia; Thrombosis; Vaccines; United States > US; South Africa

Background Real-world evaluation of the safety profile of vaccines after licensure is crucial to accurately characterise safety beyond clinical trials, support continued use, and thereby improve public confidence. The Sisonke study aimed to assess the safety and effectiveness of the Janssen Ad26.COV...