1. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study
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Linda-Gail Bekker, Nigel Garrett, Ameena Goga, Lara Fairall, Tarylee Reddy, Nonhlanhla Yende-Zuma, Reshma Kassanjee, Shirley Collie, Ian Sanne, Andrew Boulle, Ishen Seocharan, Imke Engelbrecht, Mary-Ann Davies, Jared Champion, Tommy Chen, Sarah Bennett, Selaelo Mametja, Mabatlo Semenya, Harry Moultrie, Tulio de Oliveira, Richard John Lessells, Cheryl Cohen, Waasila Jassat, Michelle Groome, Anne Von Gottberg, Engelbert Le Roux, Kentse Khuto, Dan Barouch, Hassan Mahomed, Milani Wolmarans, Petro Rousseau, Debbie Bradshaw, Michelle Mulder, Jessica Opie, Vernon Louw, Barry Jacobson, Pradeep Rowji, Jonny G Peter, Azwi Takalani, Jackline Odhiambo, Fatima Mayat, Simbarashe Takuva, Lawrence Corey, Glenda E Gray, William Brumskine, Nivashnee Naicker, Disebo Makhaza, Vimla Naicker, Logashvari Naidoo, Elizabeth Spooner, Elane van Nieuwenhuizen, Kathryn Mngadi, Maphoshane Nchabeleng, James Craig Innes, Katherine Gill, Friedrich Georg Petrick, Shaun Barnabas, Sharlaa Badal-Faesen, Sheetal Kassim, Scott Hayden Mahoney, Erica Lazarus, Anusha Nana, Rebone Molobane Maboa, Philip Kotze, Johan Lombaard, Daniel Rudolf Malan, Sheena Kotze, Phuthi Mohlala, Amy Ward, Graeme Meintjes, Dorothea Urbach, Faeezah Patel, Andreas Diacon, Khatija Ahmed, Coert Grobbelaar, Pamela Mda, Thozama Dubula, Angelique Luabeya, Musawenkosi Bhekithemba Mamba, Lesley Burgess, and Rodney Dawson
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Adult ,Male ,South Africa ,Vaccines ,Ad26COVS1 ,Adolescent ,SARS-CoV-2 ,COVID-19 ,Humans ,Female ,HIV Infections ,General Medicine ,Aged - Abstract
We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (JohnsonJohnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic.In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 10Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74·9%) were female and 119 701 (25·1%) were male, with a median age of 42·0 years (33·0-51·0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83% (95% CI 75-89) to prevent COVID-19-related deaths, 75% (69-82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67% (62-71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62% [95% CI 42-76] and during delta wave was 67% [62-71], and vaccine effectiveness against COVID-19-related death during beta wave was 86% [57-100] and during delta wave was 82% [74-89]).The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally.National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The MichaelSusan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the BillMelinda Gates Foundation.
- Published
- 2022
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