Durban - One person has died after taking the Janssen or Johnson & Johnson vaccine. On Thursday, the South African Health Products and Regulatory Authority provided an update on the adverse events following immunisation of the Covid-19 vaccine.
Sahpra said to maintain the confidentiality of the individual, no personal information will be provided.
Sahpra said this was the first death directly linked to the vaccine while there are over 100 deaths reported, they are not directly linked to the vaccine.
Sahpra CEO, Dr Boitumelo Semete, explained that the patient developed Guillain-Barré Syndrome (a syndrome is a rare disorder in which the body's immune system attacks the nerves). This was determined by a causal examination that had been conducted on the patient.
Monitoring the safety of all health products is one of Sahpra’s key functions. In the case of vaccines, the Minister of Health has appointed a specialist committee, the National Immunisation Safety Expert Committee, to specifically review and assess severe adverse events reported after immunisation and establish whether or not they are associated with the use of the vaccine.
“This is called causality assessment. Sahpra works closely with both the National Department of Health and Nisec to ensure that all reported severe adverse events are firstly investigated by the provinces and thereafter assessed for causality by Nisec. Against this background, Sahpra has been informed of a fatal case of Guillain-Barré syndrome (GBS) following vaccination with Covid-19 Vaccine Janssen,” Semete said.
She added that the causality assessment of the reported case was conducted by the Nisec using the World Health Organization’s methodology.
The case was classified as a vaccine product-related event where immunisation with the Covid-19 Vaccine Janssen was associated with the occurrence of GBS in the vaccine recipient. The events reported in the vaccine recipient were consistent with the case definition for GBS, and no other likely cause of GBS was identified at the time of illness.
The National Immunisation Safety Expert Committee's Professor Hannelie Meyer explained that GBS is a very rare illness that affects about 100 000 people around the world each year.
"Having looked at an ongoing review of vaccine safety and ongoing review of the potential risk of Guillain Barre, we are convinced and strongly convinced that the benefits of the Covid-19 vaccine in terms of preventing serious and severe Covid-19 infections and mortality greatly outweigh the very, very rare risk of some or other adverse events. However, we are committed to the ongoing review and analysis of all adverse events that are reported to us," Meyer said.
Sahpra chairperson Helen Rees said for any new medicine or vaccine, safety monitoring is important.
She said rare side effects are not seen unless the vaccine is rolled out to millions of people.
"This is what we have seen here. So safety is paramount. You've heard the word pharmacovigilance. And this is something that Sahpra is now really emphasising, and part of pharmacovigilance is what we're talking about, which is monitoring of the safety and doing causality assessments," she said.
Semete added that investigations and causality assessment of all severe reported adverse events following immunisation (AEFI) with the Covid-19 Vaccine Janssen and other Covid-19 vaccines are ongoing.
“An update on the outcome of these investigations and causality assessments will be shared with the public as they become available,” she said.