J&J vaccine rollout: SAMRC collects data on possible cases of blood clots in SA

Following the government’s decision to temporarily halt the rollout of the Johnson & Johnson (J&J) Covid-19 vaccine, the South African Medical Research Council (SAMRC) on Friday announced it was reviewing its data from the Sisonke programme with a view to restarting vaccinations.

Health Minister Dr Zweli Mkhize announced this week that the programme, which began in mid-February, would be put on hold following six reports of an extremely rare blood clotting syndrome identified in the US.

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While Mkhize said there had not been any reports of blood clots in South Africa, he said the government wanted to err on the side of caution while officials collate information on the causes of the unusual blood clots.

The Sisonke programme is a collaboration between the Department of Health, SAMRC, J&J and other organisations that allows the government to make the single dose J&J vaccine immediately available to health workers.

Before the study was halted this week, 289,787 healthcare workers had already been inoculated across the country.

In a statement on Friday, SAMRC said its investigators were working with the South African Health Products Regulatory Authority (SAHPRA) and haematology experts to review the programme’s procedures, consent process and management of side effects with a view to resuming vaccinations.

The council said safety monitoring in the Sisonke study had been extensive, with health workers provided with extensive information on the J&J vaccine.

“Following vaccination, they receive advice on side effects and an explanation on how to contact the Sisonke desk should they have any concerns, in writing and via SMS. The Sisonke desk operates a toll free number 24 hours a day seven days a week, with an on-call roster overnight.

“Side effects can also be reported on a website link distributed via SMS to all vaccinees and adverse event report forms are available at all sites for completion by the attending doctor or nurse,” SAMRC public relations manager Dumile Mlambo said.

Mlambo said to date 2.2% of health workers reported side effects or an adverse health event after they were inoculated. Most of the reported adverse events have been minor, local or systemic reactions.

“Of the reported adverse events, about 81% were identified as reactogenicity, namely common symptoms occurring usually 1-2 days after vaccination. Only 134 people (0.05%) visited a hospital or emergency room for further evaluation.

“One person experienced a severe allergic reaction that met the international diagnostic criteria for anaphylaxis but has since made a swift and complete recovery. We have noted some thromboembolic events (clotting events where the clot breaks off and travels to another part of the body to block a blood vessel) but none of these have been associated with the features described in the US – a clinical syndrome of thrombosis in the presence of thrombocytopaenia (low platelet counts).”

No reason for widespread concern

Samrc said healthcare workers who had received the J&J vaccine should not be concerned.

The organisation said the fears of blood clots only affected between one and four per million people who have been vaccinated.

“It is important to be educated about the side effects, seek care urgently if they happen, disclose your vaccination status and ask your doctor to be immediately in touch with the Sisonke team so they can guide them to treat you effectively. A headache is a common side effect of the vaccine in the first three days.”

Samrc also urged health workers seeing vaccine recipients with symptoms to establish the history of the patients’ vaccination first.

“Clots can be rapidly and easily detected using a simple full blood count to look at platelet levels. We urge all doctors and nurses who suspect a blood clot, irrespective of location, in a vaccine recipient to make immediate contact with the Sisonke desk so we can assign a safety doctor to assist you. Heparin and platelet infusions should be avoided.”

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