South African drug regulator SAHPRA reversed its decision to halt use of the Johnson & Johnson coronavirus vaccine — the only jab in use in the country — over the weekend, despite reports of multiple blood clotting reactions in those inoculated with it.
South Africa’s government has budgeted nearly $18 million for a “no-fault compensation fund” to shield COVID-19 vaccine manufacturers from claims over side-effects.
Health Minister Zweli Mkhize’s announcement came after national drug regulator SAHPRA lifted its ban on the Johnson & Johnson jab imposed after six patients in the US suffered blood clots.
Mkhize said the figure of 250 million rand (£12.7 million, $17.6 million) was based on an estimated number of 800 to 2,000 claims from patients suffering adverse events.
SAHPRA said it was cautiously lifting its suspension of a mass trial of US firm Johnson & Johnson’s single-dose jab, licensed production of which by South African company Aspen Pharmacare was supposed to begin this month.
“SAHPRA has recommended that the pause in the Sisonke study be lifted, provided that specific conditions are met”, after a “review” of data, a statement said. “These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder”.
Those receiving the jab as part of the study will be warned of the “possible risks of developing a blood clotting disorder” and “advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts”.