Sunday Times

Blood-clot risk rarer than a double lightning strike

- By CLAIRE KEETON and TANYA FARBER Additional reporting by Paul Ash

● You have a greater chance of being struck by lightning — twice — than getting a blood clot from a Covid-19 vaccine.

“To stop the vaccinatio­ns and put our health-care workers at risk is unethical and not the correct thing to do,” said Wits professor Barry Jacobson, president of the SA Society of Thrombosis and Hemostatis, after the Johnson & Johnson vaccine rollout to health workers was suspended on Tuesday.

The move followed a pause in administra­tion of the J&J vaccine by the US Food and Drug Administra­tion (FDA), to give it time to investigat­e the risk of very rare (one to four people in a million) and unusual blood-clotting disorders that could be linked to the jabs.

None of the 292,623 health workers vaccinated in SA has developed severe clotting.

Jacobson said: “I have treated doctors who have died from Covid-induced thrombosis ... there is no science or ethics to this suspension. People should fight to continue with the vaccinatio­ns.”

A new study by Oxford University scientists shows people have an eight times greater risk of developing severe cerebral blood clots from Covid-19 than from the Oxford/AstraZenec­a vaccine.

About 40 people in a million developed cerebral blood clots in the two weeks after a Covid-19 infection and about eight died, the researcher­s found. In comparison, about four to five people in a million who got the AstraZenec­a vaccine were at risk of clots. About 500,000 cases of Covid-19 in the US were analysed for the latest study, which has yet to be peer reviewed. SA’s decision to suspend its vaccinatio­ns followed the FDA pause sparked by blood clots in six out of 6.8-million Americans who had the J&J vaccine, one of whom died.

The SA Medical Research Council said: “Some countries, like France and Poland, have weighed the risks and chosen to continue to provide the J&J vaccine while this rare side-effect is considered. “The US has suspended use of the J&J vaccine for now but in a context where 37% of their population have already received one vaccinatio­n, and where alternativ­es are readily available.”

Dr Keith Cloete, head of health in the Western Cape, said the J&J vaccine was made available in SA under trial conditions. “When the FDA announces a pause, our science institutio­ns and ethics committees are virtually bound by that decision.”

Professor Linda-Gail Bekker, co-principal investigat­or of the Sisonke implementa­tion study, which has been delivering the J&J vaccines, said: “We had a very good meeting with Sahpra [ SA Health Products Regulatory Authority] and there is ... urgency on this.”

Once the FDA reached a decision, Sahpra could act. “We must wait and see,” Bekker said, adding that the Sisonke study team had 200,000 doses in hand and was ready to resume vaccinatio­ns as soon as it could.

“We were planning to be finished by the first week of May but this could eat into May,” Bekker said of their goal to protect half a million health workers.

Co-principal investigat­or professor Glenda Gray said they respected the Sahpra process given that safety was paramount.

“We have spoken to haematolog­ists and immunologi­sts who say the risk of Covid-19 outweighs the very rare clotting events. We know Covid-19 induces thrombotic events and the vaccine in some way mimics infection [to boost immunity],” she said.

Sisonke has updated informatio­n and consent forms for study participan­ts. Bekker said the rare clotting disorder seemed to develop within four to 20 days of vaccinatio­ns and people should watch out for blinding, unremittin­g headaches or abdominal pain, new-onset seizures, loss of vision or cloudy vision, new leg pain or shortness of breath.

“People should see a doctor and get hold of our safety desk [if they develop these symptoms]. They should avoid heparin [a blood thinner] until they know about their diagnosis.”

The condition is treatable and doctors have treated its cousin, “heparin-induced thrombosis”, before, she said.

Professor Ken Boffard, trauma director at Milpark Hospital, said out of 32-million people in the UK who had received the AstraZenec­a jab, 16 had developed clots.

“Everybody’s worried the hell out of the AstraZenec­a vaccine, which has the world’s most comprehens­ively documented safety trial in history,” he said. “[But] 16 out of 32 million? Get real, guys.”

AstraZenec­a vaccinatio­ns in several European countries were briefly paused last month to investigat­e rare blood-clotting disorders, and later resumed.

Wits vaccinolog­y professor Shabir Madhi said a side-effect of one in a million was “almost impossible to see in a trial of 30,00035,000, only half of whom get the actual vaccine.” —

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