The South African Health Products Regulatory Authority (Sahpra) has confirmed a second fatal case of Guillain-Barré syndrome (GBS) following vaccination with Johnson & Johnson’s Covid-19 vaccine.
Last month, Sahpra reported South Africa’s first confirmed GBS death related to J&J’s Janssen vaccine.
Read: Medicines regulator reports first death in SA linked to Covid vaccine
GBS is a rare but potentially severe neurological disorder that is associated with the administration of various vaccines and other medicines. It can also be triggered by some bacterial or viral infections, including Covid-19.
The 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.
Regulatory authorities around the world have investigated reports of GBS associated with Covid-19 vaccines. They concluded that the Janssen vaccine may increase the risk of GBS. GBS is therefore listed as a rare “adverse event” in the professional information for the vaccine.
In a statement on Monday concerning the latest fatality, Sahpra’s chief executive, Dr Boitumelo Semete-Makokotlela, said: “Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee using the World Health Organization’s 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.”
Dr Semete-Makokotlela said there were ongoing investigations into and causality assessments of all reported severe “adverse events” following immunisation with the Janssen and other Covid vaccines. The outcomes of will be shared with the public as soon as they are completed.
Saphra did not provide any information about the patient.
She said that 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”.
Saphra urged the public to report any suspected “adverse event” following the use of a medicine or vaccine. Reporting can be done at a health facility or by downloading the Med Safety App (https://medsafety.sahpra.org.za/), or by calling the Covid-19 hotline at 0800 029 999.
More information about the “adverse events” following immunisation (AEFIs) reported for the Covid-19 vaccines and how to report an AEFI is available at https://aefi-reporting.sahpra.org.za/.
