Reference:
Takuva, S., Takalani, A., Seocharan, I., Yende-Zuma, N., Reddy, T., Engelbrecht, I., Faesen, M., Khutlo, K., Whyte, C., Bailey, V., Trivella, V., Peter, J., Opie, J., Louw, V., Rowji, P., Jacobson, B., Groenewald, P., Dorrington, R. E., Laubscher, R., Bradshaw, D., Moultrie, H., Fairall, L., Sanne, I., Gail-Bekker, L., Gray, G., Gogar,
A., Garrett, N. & Sisonke Study Team. (2021). Safety of the single-dose Ad26.COV2.S vaccine among healthcare workers in the phase 3b Sisonke study in South Africa. medRxiv. https://doi.org/10.1101/2021.12.20.21267967
Summary:
The Sisonke study assessed the safety of the single-dose Ad26.COV2.S vaccine among 477,234 healthcare workers in South Africa. Monitoring of adverse events (AEs) was conducted through self-reporting, healthcare provider reports, and active case finding. Of participants, 2.2% reported AEs, with a higher incidence among women and younger individuals. The most common reactions included headaches and body aches. Serious AEs were rare, with only 139 cases (1.4%), and occurred at a lower rate than expected in the general population. Notably, two cases of Thrombosis with Thrombocytopenia Syndrome and four cases of Guillain-Barre Syndrome were reported. Overall, the vaccine demonstrated an acceptable safety profile, supporting its continued use in healthcare settings, especially considering the high burden of COVID-19 in South Africa.