Regulator calls for roll-out to resume

THE South African Health Products Regulatory Authority (Sahpra) has recommended the lifting of the suspension of the Johnson & Johnson Covid19 vaccine roll-out, with conditions.

It said it had studied the data from the roll-out and found no reports of major health concerns.

This comes after Health Minister Zweli Mkhize announced the voluntary suspension of the Johnson & Johnson Covid-19 vaccine roll-out, which is being administered to healthcare workers, under the Sisonke Phase 3B Implementation Study.

Sahpra said they had engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, as well as the adverse events reported in the US.

Based on their review of the available data, Sahpra recommended that the pause in the Sisonke study be lifted, provided that specific conditions were met. These included strengthened screening and monitoring of participants who were at high risk of a blood-clotting disorder and measures were to be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia (VITT).

It said: “Participants in the Sisonke study will be informed about the possible risks of developing a blood-clotting disorder after vaccination.

“They will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts.”

Mkhize announced the decision to halt the vaccine roll-out last week after the Food and Drug Administration (FDA) in the US advised the temporary suspension of the vaccine roll-out in that country. Six women in the US developed a rare blood-clotting disorder after getting the vaccine.

Experts in South Africa said the vaccination roll-out should not have been suspended in the country.

Clinical haematologist Dr Jacques Malherbe, who heads the Clinical Haematology division at the University of the Free State’s Department of Internal Medicine, said thrombotic events or blood-clotting associated with the Johnson & Johnson and AstraZeneca vaccines were extremely rare.

“The risk of thrombosis is lower than the risk seen with many other common treatments, most notably hormonal contraception,” he said.

He further noted that the thrombosis incidence in Covid-19 infection was very high, at 3% for non-ICU patients, while the incidence in ICU patients was even higher, ranging from 7.2% to 13.6%.

Malherbe said the risk benefit analysis was in favour of continuing with the Johnson & Johnson vaccine.

“My opinion is that the vaccine roll-out should not have been stopped or at least should be restarted immediately,” he said.

Speaking to SAfm last week, Professor Barry Jacobson, haematologist and director of the Thrombosis and Haemostasis Research Unit at Wits University Health Consortium, said vaccine-induced blood clots were rare.

“I think that the world's reaction, especially the American reaction to stopping this is really overkill, far more people will die from thrombosis caused by Covid-19,” said Jacobson.

In dealing with thrombotic problems associated with Covid-19, Jacobson said Covid-19 was a much more dangerous condition.