The South African Health Products Regulatory Authority (Sahpra) has reported that one person has died after having the Covid-19 vaccine Janssen administered.
The regulatory authority announced on Thursday morning while providing an update on adverse events following immunisation.
According to Sahpra, Janssen was one of the vaccines provided in the national roll-out, which commenced on May 17 2021 and to date had administered in over 9.1 million doses in South Africa.
CEO Dr Boitumelo Semete-Makokotlela said Sahpra had been informed of a fatal case of Guillain-Barré syndrome following vaccination with the Janssen vaccine.
She explained that the Guillain-Barré syndrome was a rare but severe adverse event that was associated with the administration of various vaccines and other medicines and could also be triggered by infections, such as SARS-CoV-2.
“It is a rare condition affecting the body’s immune system and symptoms can vary from mild to severe, and include muscle weakness, muscle pain, numbness and tingling. In many cases, Guillain-Barré syndrome gets better with no serious after-effects but in some cases, it can become serious and cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate. Guillain-Barré syndrome-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.”
She added investigations and causality assessment of all severe reported adverse events following immunisation with the Covid-19 vaccine Janssen and other Covid-19 vaccines were ongoing and an update on the outcome would be shared with the public as they become available.
NISEC CEO Professor Hannelie Meyer said when it comes to Covid-19 vaccinations, an investigation was done by many disciplinary teams in provinces where they collected all the necessary information about the case before the vaccination, as well as what followed the vaccination.
She added it was also important to look at whether this happened during a certain window, and the deceased presented with symptoms soon after vaccination.
Health Minister Dr Joe Phaahla said most adverse events following immunisation were mild and were resolved within a few days.
“Since the introduction of the Covid-19 vaccine, there had been over 37.2 million doses that had been administered. Up to July 15 this year, just over 6 200 adverse events were reported to Sahpra, which indicated reporting of adverse events of 0.017%. If a serious adverse event is linked to the use of the Covid-19 vaccine, the case will be considered for compensation. Vaccine reporting aims to maintain a high level of vaccine confidence in the public through continuous monitoring of safety.
“Covid-19 vaccine remains very safe and effective in protecting us against serious illness and hospitalisation,” Phaahla said.