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Sahpra recommends lifting the J&J vaccine suspension

The South African Health Products Regulatory Authority (Sahpra) has recommended the pause on the rollout of the Johnson & Johnson (J&J) vaccine be lifted.
The country's health department put the J&J vaccine on hold, after the US’ Food and Drug Administration paused the vaccine after reports of six women, out of 6.6-milion doses administered, developed rare cerebral venous thrombosis, with low blood levels of blood platelets.

SA temporarily suspends J&J jab

The South African Department of Health has put the Johnson & Johnson Covid-19 vaccine on hold temporarily, while it investigates a possible link between the jab and a rare blood clot disorder...

14 Apr 2021



Sahpra said in a statement that it had engaged with the J&J’s Sisonke phase 3B implementation study team and Janssen Pharmaceutica to discuss the safety of the vaccines as well as the adverse findings reported in the US.

“Based on their review of the available data, Sahpra has recommended that the pause in the Sisonke study be lifted, provided that specific conditions are met.”

Healthcare workers participating in the Sisonke study will also 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.”
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