SAHPRA reviewing data after suspension of J&J vaccine
Durban - The South African Health Products Regulatory Authority(SAHPRA) said no major safety concerns have been identified with the Sisonke Johnson & Johnson vaccine implementation study.
This follows the announcement by Health Minister Zweli Mkhize on Tuesday night that the Johnson & Johnson vaccine roll-out would be temporarily suspended in SA.
The announcement came after six women in the US, between the ages of 18 and 48, developed a rare blood clotting disorder after getting the vaccine.
SAHPRA said together with its scientific expert committees it has recently reviewed the data from the Sisonke Phase 3b implementation study, which involves the administration of the Covid-19 vaccine.
“Based on the data, no major safety concerns have been identified. No causal relationship between vaccination and the development of blood clots is evident at this stage.”
However, the authority said following the decision by the United States Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention (CDC) to pause the use of the vaccine in that country, SAHPRA met with the Sisonke study team and the manufacturer, Janssen Pharmaceutical, on April 13, 2021.
SAHPRA said it was provided with updated data on the Sisonke study while further data is being obtained from the manufacturer and the US FDA.
“SAHPRA has requested a pause in the implementation of the Sisonke study to enable it to review the relevant data and further updates will be communicated in due course.”
The authority said this process is expected to take a few days.
Based on the latest Covid-19 stats for the Department of Health, over 292 000 healthcare workers have been vaccinated.