The vaccination of SA healthcare workers against Covid-19 will resume on Wednesday and the teams responsible have enough doses and are primed for action, said the scientists driving the delivery.
Prof Glenda Gray, co-principal investigator of the Sisonke implementation study, which is providing Covid-19 Johnson & Johnson (J&J) vaccines, said: “Our teams are raring to go and anxious to get back into the field and complete the study.”
The vaccinations were paused by the SA Health Products Regulatory Authority (Sahpra) on April 13, 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.
On Tuesday, the health department announced the J&J vaccinations would resume on Wednesday.
A review of the J&J vaccine had found there was a one in a million chance of getting a clot after the shot so globally regulators had advised the continued use of the J&J vaccine, health minister Zweli Mkhize said.
The Sisonke team was required to send its updated protocols to Sahpra and the ethics committees attached to the study for review after the pause.
These included steps for more rigorous pre-vaccination screening and post-vaccination monitoring of participants at risk of blood clotting disorders.
Sisonke co-principal investigator Prof Linda-Gail Bekker said: “All the Sisonke material, such as the informed consent forms, [now] contain information about the very rare possible side-effect of Covid-19 vaccinations so individuals can exercise their own informed choice.
The vaccination is protective and highly beneficial.
— Prof Linda-Gail Bekker
“The strong recommendation remains that if you have a risk of Covid-19 exposure then the vaccination is protective and highly beneficial.
“We will be moving ahead as planned with the remaining 200,000 J&J doses,” said Bekker about the inoculations at more than 90 sites nationally.
The Sisonke Phase 3B study is providing Covid-19 J&J vaccines to 500,000 healthcare 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 — which will be two weeks when it is lifted on Wednesday — 292,623 healthcare workers had received J&J jabs with no reports of the unusual blood clots.
Wits University’s Prof Barry Jacobson, president of the SA Society of Thrombosis and Hemostatis, has slammed the pause in vaccinations.
“To stop the vaccinations and put our healthcare workers at risk is unethical and not the correct thing to do,” he said.
The J&J Covid-19 vaccinations are the only ones available to South Africans at present, unlike other countries.
Four to five people per million have developed the clotting disorder being investigated with the J&J vaccine after inoculations with the Pfizer, Moderna and AstraZeneca Covid-19 vaccines.
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