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Health-care workers in J&J vaccine trial must re-consent as roll-out resumes

The Johnson and Johnson (J&J) Sisonke Programme to vaccinate health-care workers is part of the first phase of the Covid-19 vaccine roll-out. Photographer: Armand Hough/African News Agency(ANA)

The Johnson and Johnson (J&J) Sisonke Programme to vaccinate health-care workers is part of the first phase of the Covid-19 vaccine roll-out. Photographer: Armand Hough/African News Agency(ANA)

Published Apr 28, 2021

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CAPE TOWN – The Western Cape Health Department said that the health-care workers who have been vaccinated already as part of the Johnson and Johnson Sisonke Programme, will have to re-consent to participating as the roll-out resumes today.

The Johnson and Johnson (J&J) Sisonke Programme to vaccinate health-care workers, is part of the first phase of the Covid-19 vaccine roll-out in the country which resumes today.

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The vaccine trial was paused temporarily to ensure the safety of the vaccine after a very small percentage (6 out of more than 6 million people) of participants in overseas vaccination programmes suffered an extremely rare clotting disorder.

As a condition for resuming the Covid-19 vaccination trial programme, the South African Health Products Regulatory Authority has added a requirement that all Sisonke participants need to be informed of the potential risk of the rare clotting disorder and therefore re-consent to participating.

“The revisions also pertain to the additional Sahpra recommendation that pregnant and breastfeeding women should be excluded from the trial at this stage,” the health department said.

Those who have been vaccinated will receive an SMS with a safety update on the Johnson & Johnson vaccine.

Meanwhile health workers who have a voucher but have not been vaccinated yet will have to get new vouchers.

“Your current voucher is no longer valid. You will receive an SMS requesting you to read the new participant information and provide consent. Once you’ve consented, you will receive a new vaccine voucher. You will use this new vaccine voucher when you present for your vaccination,” the health department said.

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Health workers who have registered but have not received a voucher or a vaccination will receive a SMS inviting them to the Sisonke programme.

“You will have to read the new participant information and provide consent. When you are eligible for your vaccination, you will receive a voucher. You will use this voucher when you present for your vaccination,” the department said.

Health workers who have not registered for the vaccine are advised to register as soon as possible. Health workers can only receive the vaccination during Phase 1 if they have registered to be part of the Sisonke Programme.

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If they do not register now, they will have to wait for their turn during Phase 2 and 3 roll-out.

The health department encouraged health-care workers to register here: https://vaccination.health.gov.za.

The scheduling process is still in operation for all health-care workers in public sector. The updated consent form will need to be completed by all participants prior to vaccination.

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