Sahpra recommends heightened safety regulations for continuation of J&J trial

The study was temporarily halted last week after a US regulator pressed pause on the rollout of the Johnson & Johnson vaccine in that country.

 A vaccinator showing a healthcare worker the COVID-19 vaccine on the first day of South Africa's vaccine rollout on 17 February 2021. Picture: Abigail Javier/Eyewitness News

CAPE TOWN - It's now up to an ethics committee to sign off on a South African Health Products Regulatory Authority (Sahpra) recommendation to allow a COVID-19 vaccine trial to start up again.

The study was temporarily halted last week after a US regulator pressed pause on the rollout of the Johnson & Johnson vaccine in that country.

It came after six women developed a rare blood clot.

Sahpra followed its US counterpart's move but has now recommended a conditional lifting of the suspension.

Sahpra's Dr Boitumelo Semete-Makokotlela said that the protocol would now have to change and heightened safety regulations would be required.

"The screening and monitoring of the participants, particularly those with high risks of blood clotting. Secondly, the safe management and immediate management of any participants who may present with any vaccine-induced thrombosis."

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