Johnson & Johnson Sisonke trial to resume on Wednesday

South Africa will resume the Johnson & Johnson Sisonke trial on Wednesday following Sahpra’s (South African Health Products Authority) recommendation.

“The programme has all the doses it needs to complete vaccinating 500 000 healthcare workers through the early access protocol and the teams have been eagerly standing by, looking forward to making up for lost time by completing this programme in the shortest possible time,” said government on Monday.

Vaccination sites will also be expanded to 95.

Sahpra has recommended that pregnant and lactating women be excluded from the Sisonke Protocol at this stage.

Anyone who experiences headaches, abdominal pain, vomiting, blurry vision or other neurological or abdominal symptoms after being vaccinated is urged to call the Covid-19 hotline on 0800 029 999.

Sahpra’s decision to suspend the rollout was announced by Health Minister Zweli Mkhize on 13 April.

This was after the US paused its rollout due to reported blood clots in recipients.

“We have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated,” Mkhize said at the time.

He said SAHPRA would collate information from Johnson & Johnson and other regulatory bodies to make a thorough assessment of the situation.

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The Sisonke Protocol had vaccinated 292,623 healthcare workers before it was paused

Following the announcement, Professor Glenda Gray, co-principal investigator of the Sisonke implementation study, said they had developed a plan to manage the processes better.

“We have amended the study to optimise our ability to identify these conditions [blood clots] should they arise and also have developed a plan how to manage these conditions in the event of them happening,” she told The Citizen.

“We will also increase public awareness. The pause gave the regulatory authorities time to review the data and indicate how they wanted us to alter the study to enhance safety.”