Details

Autor(en) / Beteiligte

• Takalani, Azwidihwi
• Robinson, Michelle
• Jonas, Phumeza
• Bodenstein, Annie
• Sambo, Vuyelo
• Jacobson, Barry
• Louw, Vernon
• Opie, Jessica
• Peter, Jonny
• Rowji, Pradeep
• Seocharan, Ishen
• Reddy, Tarylee
• Yende-Zuma, Nonhlanhla
• Khutho, Kentse
• Sanne, Ian
• Bekker, Linda-Gail
• Gray, Glenda
• Garrett, Nigel
• Goga, Ameena

Titel

Safety of a second homologous Ad26.COV2.S vaccine among healthcare workers in the phase 3b implementation Sisonke study in South Africa

Ist Teil von

• Vaccine, 2024-02, Vol.42 (6), p.1195-1199

Ort / Verlag

Netherlands: Elsevier Ltd

Erscheinungsjahr

2024

Quelle

Access via ScienceDirect (Elsevier)

Beschreibungen/Notizen

• The Sisonke 2 study provided a homologous boost at least 6 months after administration of the priming dose of Ad26.COV2.S for healthcare workers enrolled on the Sisonke phase 3b implementation study. Safety monitoring was via five reporting sources: (i.) self-report through a web-link; (ii.) paper-based case report forms; (iii.) a toll-free telephonic reporting line; (iv.) healthcare professionals-initiated reports; and (v.) active linkage with National Disease Databases. A total of 2350 adverse events were reported by 2117 of the 240 888 (0.88%) participants enrolled; 1625 of the 2350 reported events are reactogenicity events and 28 adverse events met seriousness criteria. No cases of thrombosis with thrombocytopaenia syndrome were reported; all adverse events including thromboembolic disorders occurred at a rate below the expected population rates apart from one case of Guillain Barre Syndrome and one case of portal vein thrombosis. The Sisonke 2 study demonstrates that two doses of Ad26.COV2.S is safe and well tolerated; and provides a feasible model for national pharmacovigilance strategies for low- and middle-income settings.