The South African Health Products Regulatory Authority (SAHPRA) has recommended that the pause of the Sisonke vaccine trial study using the Johnson & Johnson Covid-19 vaccine be lifted, provided that specific conditions are met.
The US, South Africa and the European Union temporarily stopped the rollout of the Johnson & Johnson jab, after six cases of rare blood clotting were reported in the US.
SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica, which is owned by Johnson & Johnson, to discuss the safety data reported from the Sisonke study.
“These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder. In addition, measures are to be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia. The participant information sheets and informed consent forms will be updated to include the newly identified adverse events,” said SAHPRA.
The authority has highlighted that participants in the Sisonke study will be informed about the possible risks of developing a blood clotting disorder after vaccination and will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts.
It added that the study team will submit the required updated documents, procedures and study arrangements to SAHPRA for approval.
SAHPRA said the resumption of the Sisonke Phase 3B Implementation Study will also require approval from the relevant Research Ethics Committees.