One patient has died of a rare immune disease after receiving the Johnson & Johnson (J&J) vaccine, the South African Health Products Regulatory Authority (Sahpra) confirmed on Thursday.
Boitumelo Semete-Makokotlela, the Sahpra CEO said: “It is with sad hearts today that we confirm that Sahpra has been informed of a fatal case of a syndrome called Guillain-Barré (GBS). This was a case noted following vaccination with the Covid-19 Janssen vaccine.
“The causality assessment was conducted…and there is a conclusion that this case of GBS was associated with the individual who had received the Covid-19 Janssen vaccine.”
Sahpra did not reveal any details about the deceased patient. Semete-Makokotlela said this was the first death they had investigated that they determined could be causally linked to the vaccine.
The health department and Sahpra encouraged people to continue to get vaccinated, stating the risk of death was still minuscule.
Professor Marc Blockman, a member of the Sahpra board, said that GBS affected a patient’s immune system. According to Blockman, the disease affected 100 000 people a year globally. “It is characterised by a rapid and ascending weakness. The weakness starts from the lower limbs and ascends up the body. It has the potential to affect the respiratory system … and may affect the brain as well.”
“What we found, in this case, is that indeed it was a case of Guillain-Barré Syndrome and we know that this is a very rare event, but it has been diagnosed in this person.”
Meyer said the committee investigated what had caused the syndrome. “At the time of illness, no other cause of Guillain-Barré was discovered in this person.”
She said the patient presented symptoms of GBS fairly soon after vaccination and required urgent hospitalisation. She said the person was on a ventilator. “It led to further complications and infections and eventually led to death.”
More than 9 million J&J vaccines have been administered in the South Africa so far, Semete-Makokotlela said. Health minister Dr. Joe Phaahla said only 6 200 adverse events had been reported to Sahpra.
Professor Helen Rees, the chairperson of the Sahpra board, said the benefits of vaccination far outweighed the risks.
“In South Africa, we have already lost 100 000 people because of Covid. The one thing that the vaccines do very well is prevent severe disease and death. Our responsibility as a regulator is to inform the public but also reassure them that we are looking at all these incidents.”