The second death related to Guillain-Barré syndrome (GBS) was confirmed on Monday after a patient received a Janssen Covid-19 vaccine, the SA Health Products Regulatory Authority (SAHPRA) has said.
“Causality assessment of the reported case was conducted by the national immunisation safety expert committee using the World Health Organisation’s methodology,” according to a statement from SAHPRA.
“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.”
On August 4, SAHPRA reported the first fatal case of GBS following vaccination.
GBS is a rare but potentially severe neurological adverse event associated with the administration of various vaccines and other medicines. It can also be triggered by some 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. In many cases, GBS resolves with no serious after-effects, but in some cases it can cause serious or life-threatening problems.
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 for Covid-19 Vaccine Janssen. Investigations and causality assessment of all reported severe AEFI [adverse event following immunisation] 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.”
It added that the Covid-19 vaccines has 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.”
SAHPRA further urged the public to report any suspected adverse events following the use of all medicines and vaccines.
Reporting can be done at a health facility or by downloading the Med Safety App (https://medsafety.sahpra.org.za/) which is available for Android and iOS phones, or by calling the Covid-19 hotline at 0800 029 999.
More information regarding AEFIs reported for the Covid-19 vaccines and how to report an AEFI is available from the SAHPRA website: https://aefi-reporting.sahpra.org.za/.
Also Read: Fatal case of GBS reported following Covid-19 vaccination
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