A fatal case of Guillain-Barré syndrome (GBS) has been reported following immunisation with Covid-19 vaccine Janssen, the SA Health Products Regulatory Authority (Sahpra) said on Thursday.
“A causality assessment of the reported case was conducted by the Nisec [national immunisation safety expert committee] using the World Health Organisation’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,” said Sahpra in a statement.
GBS is a rare condition affecting the body’s immune system. Sahpra said the disease can be triggered by infections such as SARS-CoV-2, but GBS has been listed as a rare adverse event for Covid-19 vaccine Janssen.
Symptoms of GBS can vary from mild to severe and include muscle weakness, muscle pain, numbness, and tingling.
“In many cases, GBS 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.
“GBS-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.”
At the end of March in 2021, the authority approved the use of the Covid-19 vaccine Janssen for individuals above 18 years as a single primary vaccination dose. Covid-19 vaccine Janssen was later approved as a single booster dose given at least two months after the primary vaccination dose.
In December 2021, the vaccine was approved as a booster dose and to date, 9 135 189 doses of the vaccine have been administered in South Africa.
The authority further said regulatory authorities around the globe have previously investigated reports of GBS associated with Covid-19 vaccines.
“In July 2021, the European Medicines Agency conducted a review of 108 suspected cases of GBS reported worldwide after 21-million people had received the Covid-19 vaccine Janssen. They concluded that there is a possible increased risk and causal relationship between GBS occurrence and the Covid-19 vaccine Janssen.
It said monitoring the safety of all health products is one of Sahpra’s key functions and that the health minister had appointed Nisec 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 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.
“Investigations and causality assessment of all severe reported adverse events following immunisation with the Covid-19 vaccine Janssen and other Covid-19 vaccines is ongoing. An update on the outcome of these investigations and causality assessments will be shared with the public as they become available.”
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