Second death linked to Janssen Covid-19 vaccine

A second fatal case of Guillain-Barré syndrome has been confirmed after vaccination with the Janssen jab for Covid-19, the SA Health Products Regulatory Authority said.

The first case was confirmed on August 4.

No details about the latest case were disclosed.

Sahpra said: “Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology.

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.”

GBS is a rare but potentially severe neurological adverse event associated with the administration of various vaccines and other medicines and can also be triggered by bacterial or viral infections, including SARS-CoV-2. Symptoms of GBS range from mild to severe, and may include muscle weakness, muscle pain, numbness, and tingling.

Sahpra said in many cases, GBS resolves with no serious after-effects, but in some cases it can cause serious or life-threatening problems.

It noted: “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.

“Investigations and causality assessment of all reported severe AEFI with the Covid-19 Vaccine Janssen and other Covid-19 vaccines are ongoing.

The outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.”

Sahpra emphasised 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.

The public are strongly advised not to delay Covid-19 vaccination if eligible in terms of the national vaccination programme.”

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