Prof Glenda Gray, co-principal investigator of the Sisonke implementation study, which is providing health-care workers with Covid-19 J&J vaccines, said on Monday morning the suspension of the inoculations is expected to be lifted soon.
The vaccinations were paused by the SA Health Products Regulatory Authority (Sahpra) on Tuesday night last week, the same day the US Food and Drug Administration paused its J&J rollout because of extremely rare and severe blood clots detected in six out of 6.8 million Americans vaccinated.
Gray said the Sisonke team had sent Sahpra its updated protocols. These include steps for more rigorous screening and monitoring of participants at risk of blood clotting disorders, and enhanced safety measures.
She said early on Monday morning: “We sent all the necessary documentation, including the updated protocol, through to Sahpra and we are expecting [the resumption] to happen, but do not yet have any formal notification.”
Sisonke has vaccine doses in hand and is ready to resume the jabs as soon as it gets the green light from regulatory and ethics bodies.
The Sisonke phase 3B study is providing Covid-19 J&J vaccines to half a million health-care workers and the health department is expected to cover the remaining 500,000 to 700,000 next in the first phase of its national rollout.
At the time of the pause, 292,623 health-care workers had received J&J vaccinations, with no reports of these unusual blood clots.
Sahpra recommended on Saturday night that the temporary pause in the rollout of the Johnson & Johnson vaccine be lifted “provided that specific conditions are met”.
University ethics committees must also approve the resumption of the study. Prof Marc Blockman, chair of the human research ethics committee at UCT’s health faculty, told Business Day: “Once we have received the formal documentation, we will be able to critically evaluate it and turn it around very quickly.”
Wits professor Barry Jacobson, president of the SA Society of Thrombosis and Hemostasis, has slammed the pause in vaccinations. “To stop the vaccinations and put our health-care workers at risk is unethical and not the correct thing to do,” he said.
Unlike the US, the J&J Covid-19 vaccinations are the only ones available to South Africans at present.
SA is waiting for an order of Pfizer vaccines, which are being used in the US along with Moderna vaccines.
Four to five people per million have also developed the unusual clotting disorder — being investigated with the J&J vaccine — after inoculations with the Pfizer, Moderna and AstraZeneca Covid-19 vaccines, a new study by Oxford University found.
Jacobson said people have a greater chance of being struck by lightning — twice — than getting a blood clot from a J&J Covid-19 vaccine.