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 COVID‑19, 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 COVID‑19 breakthrough infections; and (x) flexibility
and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.
