SAHPRA recommends lift of J&J rollout suspension
Sahpra said that it has since engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica.
A nurse prepares a dose of vaccine.
The South African Health Products Regulatory Authority (Sahpra) has made recommendations that the suspension of J&J vaccine rollout be lifted subject to conditions.
Last week, health Minister Dr Zweli Mkhize announced that South Africa “voluntarily” suspended its intended rollout of the J&J Covid-19 vaccine, after the United States paused their rollout due to reported blood clots in recipients.
Sahpra said that it has since engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica.
“The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the Covid-19 vaccine Janssen, as well as the adverse events reported in the United States of America,” reads the regulator’s statement.
The body has since recommended lifting the suspension on the Sisonke study, but says there should be better screening and monitoring of participants at high risk of blood clotting disorders.
Six people in the world have since been reported to have developed a blood clotting disorder after receiving the Johnson & Johnson vaccine.
Sahpra said that in addition, measures are to be implemented to ensure the safe management of any participants who develop vaccine- induced thrombosis and thrombocytopenia (VITT).
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Participant information sheets and informed consent forms will be updated to include the newly identified adverse events.
“Participants in the Sisonke study will be informed about the possible risks of developing a blood clotting disorder after vaccination. They will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts.
“The study team will submit the required updated documents, procedures and study arrangements to SAHPRA for approval,” reads the statement.
The resumption of the Sisonke Phase 3B Implementation Study will also require approval from the relevant Research Ethics Committees.
