South Africa recorded one death as a result of a Covid-19 vaccination, the SA Health Products and Regulatory Authority (Sahpra) said.
Sahpra and the National Department of Health provided an update on Adverse Events Following Immunisation (AEFIs) at a media briefing yesterday.
Health Minister Dr Joe Phaahla explained that an AEFI is any untoward medical event which follows immunisation and does not necessarily have a causal relationship with the use of the vaccine. He said most AEFIs are mild and resolve within a few days.
AEFIs are reported through the medicine safety application on the Covid-19 call centre or any healthcare facility and after AEFI are reported, all severe and serious events are fully investigated by provincial departments of Health.
Once the investigations are concluded, the cases are forwarded to the National Immunisation Safety Expert Committee to determine if these AEFIs are linked to the vaccine.
According to the Phaahla, over 6 200 AEFIs were reported to Sahpra up to July 15, meaning the reporting of AEFIs was around 0,01% of 36,2 million doses of Pfizer and J&J were administered in the country in total.
“The aim of the AEFIs reporting system is to maintain a high level of vaccine confidence in the public through continuous monitoring of safety and efficacy data collected within the immunisation programme,” Phaahla said.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela announced there was one fatal case of Guillain-Barré syndrome (GBS) that was noted following the vaccination with the Johnson&Johnson vaccine.
“In this assessment, there is a conclusion that this case of GBS was associated with the event that the individual had received the Covid-19 Jansen vaccine,” the chief executive said.
The chairperson of NISC, Professor Hannelie Meyer, explained that in the case, there was evidence that it was indeed a case of GBS, but added that it was a very rare but serious adverse event but it was diagnosed in the patient.
Meyer stressed that GBS was one of possible adverse events listed in the information the Jansen vaccine.
“In this case, at the time of illness, no other cause for the GBS could be identified in this person… This person presented with symptoms soon after vaccination,” Meyer said.
She added that the deceased patient presented with symptoms following vaccination within the specified time period and this resulted in prolonged hospitalisation which required mechanical ventilation.
“That in itself also led to further complications and infections. Eventually it resulted in death,” the chairperson said.
Chairperson of Sahpra pharmacovigilance, Professor Marc Blockman, explained that GBS was a very rare event that affects the immune system of patients. Blockman said it affects about 100 000 people globally annually, about 1 in 100 000 patients that present may have the syndrome.
“It can be mild but also has a serious element. It is characterised by a rapid ascending weakness, meaning that the weakness starts at the low limps and ascends up the body. It may cause limb weakness but also has the potential to affect the respiratory system,” Blockman said.
Sahpra emphasised that the Covid-19 vaccines remained safe and effective in protecting South Africans against serious illness and hospitalisation.
“Having looked at an ongoing review of vaccine safety, ongoing review of GBS and this tragic case, we are convinced that the benefits of the Covid-19 vaccine greatly outweigh the very very rare risk of GBS and other adverse events,” Blockman added.