No major safety issues identified during Sisonke COVID-19 vaccine study - Sahpra

On Tuesday, government temporarily suspended the further use of the Johnson & Johnson vaccine which was being used in the study following blood clotting concerns in the US.

A health care worker at Chris Hani Baragwanath Hospital prepares a COVID-19 vaccination on the first day of the vaccine rollout to frontline workers on 17 February 2021. Picture: Abigail Javier/Eyewitness News.

JOHANNESBURG - The South African Health Products Authority (Sahpra) has on Wednesday reiterated that no major safety concerns had been identified during the rollout of the Sisonke COVID-19 vaccine study.

On Tuesday, government temporarily suspended the further use of the Johnson & Johnson vaccine, which was being used in the study following blood clotting concerns in the US.

Six cases were detected out of the nearly 7 million doses distributed.

Sahpra board chair, Professor Helen Rees, said no causal relationship between the shot and the development of blood clots was evident at this stage but further probes were being done.

"The role of Sahpra as a regulatory authority is to look at the safety, quality and efficacy of all medicines in the public interest and safety is always is on the top of that list."

Globally, questions are being asked about the safety of the Johnson & Johnson coronavirus vaccine and Sahpra said more data was being obtained.

Sahpra is in talks with Johnson & Johnson and the US Food and Drug Administration to gather more information.

Rees said: “We will have a full discussion once we’ve understood whether there is a link with this rare side effect or not."

The investigation could take a few days.

South Africa is set to use 31 million doses of the single shot Johnson & Johnson vaccine in its mass inoculation programme set to start in May.

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