ONE person has died after reportedly taking a Covid-19 vaccination.
This was revealed by the South African Health Products Regulatory Authority (SAHPRA) during a virtual media briefing on Thursday, 4 August.
SAHPRA was giving an update regarding the Adverse Events Following Immunisation (AEFI).
Chief executive officer Dr Boitumelo Semete-Makokotlela said the person died following immunisation with the Johnson & Johnson vaccine.
“The patient was diagnosed with Guillain-Barré Syndrome, also referred to as GBS, which is a rare disorder where the body’s immune system damages the nervous system. This case was noted following vaccination. Due to patient confidentiality, no details regarding the case may be shared,” she said.
She said that GBS was a very rare but severe adverse event that was associated with the administration of various vaccines and other medicines, and could also be triggered by infections such as SARS-CoV-2.
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“Symptoms can vary from being 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, it can become serious and cause paralysis and other serious or life-threatening problems such as breathing problems and abnormal blood pressure or heart rate,” she said, adding that GBS-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.
Semete-Makokotlela further said regulatory authorities had previously investigated reports of GBS associated with Covid-19 vaccines. She said 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 vaccine.
She said they concluded that there was a possible increased risk and causal relationship between GBS occurrence and the vaccine.
GBS is therefore listed as a rare adverse event in the Professional Information for vaccine.
“Investigations and causality assessment of all severe reported adverse events following immunisation with the Johnson & Johnson vaccine and other vaccines is ongoing. An update on the outcome and causality assessments will be shared with the public as they become available.”
