The South African Health Products Regulatory Authority (Sahpra) said it has been informed that a second person has died of Guillain-Barré syndrome (GBS) following vaccination with the Jansen Covid-19 Vaccine.
This comes after the regulator issued a media statement relating to the first fatal case of GBS following vaccination with Janssen Covid-19 vaccine.
Sahpra said the causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology.
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“The case was classified as a vaccine product-related event following investigations conducted and causality assessment. The events reported in the vaccine recipient were consistent with the case definition of GBS and no other likely cause of GBS was identified at the time of illness.”
“As previously communicated, GBS is a very rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by some bacterial or viral infections, including SARS-CoV-2,” Sahpra said.
GBS Symptoms
Symptoms of GBS range from mild to severe, and may include muscle weakness, muscle pain, numbness, and tingling.
In many cases, GBS resolves with no serious after-effects, but in some cases GBS can cause serious or life-threatening problems.
GBS and Covid-19 vaccines
Sahpra said regulatory authorities have previously investigated reports of GBS associated with Covid-19 vaccines.
“They concluded that Covid-19 Vaccine Janssen may increase the risk of GBS. GBS is, therefore, listed as a rare adverse event in the professional information (PI) for Covid-19 Vaccine Janssen.
Sahpra said investigations and causality assessment of all reported severe AEFI with the Covid-19 Vaccine Janssen and other Covid-19 vaccines are ongoing.
Sahpra added that the outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.
Covid-19 vaccines
Covid-19 vaccines have consistently been shown to prevent severe forms of disease, hospitalisation and death. Based on the currently available evidence, SAHPRA has determined that the benefits of Covid-19 vaccination far outweigh the very low risk of severe adverse events, including GBS,” Sahpra said.
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