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Sisonke phase 3B open-label study: Lessons learnt for national and global vaccination scale-up during epidemics.
Goga, A E; Bekker, L-G; Garrett, N; Takuva, S; Sanne, I; Odhiambo, J; Mayat, F; Fairall, L; Brey, Z; Bamford, L; Tanna, G; Grey, G.
  • Goga AE; South African Medical Research Council, South Africa; Department of Paediatrics and Child Health, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa. ameena.goga@mrc.ac.za.
S Afr Med J ; 112(2b): 13486, 2021 12 24.
Article in English | MEDLINE | ID: covidwho-1678836
ABSTRACT
Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID­19, including hospitalisations and deaths. The  Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID­19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.
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Collection: International databases Database: MEDLINE Main subject: Mass Vaccination / Health Personnel / Infectious Disease Transmission, Patient-to-Professional / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Observational study / Risk factors Topics: Vaccines Limits: Humans Country/Region as subject: Africa Language: English Journal: S Afr Med J Year: 2021 Document Type: Article Affiliation country: South Africa

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Collection: International databases Database: MEDLINE Main subject: Mass Vaccination / Health Personnel / Infectious Disease Transmission, Patient-to-Professional / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Observational study / Risk factors Topics: Vaccines Limits: Humans Country/Region as subject: Africa Language: English Journal: S Afr Med J Year: 2021 Document Type: Article Affiliation country: South Africa