The SA Health Products Regulatory Authority (Sahpra) says no major safety concerns have been identified in the country so far with the J&J Covid-19 vaccine.
The authority, an entity of the national department of health, said it, together with its scientific expert committees, recently reviewed the data from the Sisonke phase 3b implementation study.
“Based on these data, no major safety concerns have been identified. No causal relationship between vaccination and the development of blot clots is evident at this stage.”
However, after the decision by the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to pause the use of the J&J vaccine in that country, Sahpra met with the Sisonke study team and the manufacturer Janssen Pharmaceutical on Tuesday.