The South African Health Products Regulatory Authority (SAHPRA) has confirmed that a person died of Guillain-Barré syndrome (GBS) after receiving the approved Johnson & Johnson COVID-19 vaccine.
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GBS has been identified before as a possible side-effect of the vaccine. It has also been identified as a post-infection complication of COVID-19.
GBS is a rare condition affecting the body’s immune system. Symptoms of GBS can vary from 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 cases, GBS can become serious and cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate. GBS-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.
To protect patient confidentiality, no patient details nor the province where the death occurred, will be made public.
Professor Hannelie Meyer from the National Immunisation Safety Committee said, “It is a very rare event. The person presented with the symptoms shortly after vaccination and this had led to prolonged hospitalisation, mechanical ventilation and further infections.”
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Professor Marc Blokman, who specialises in clinical pharmacology said that GBS was very rare, affecting about 100,000 people worldwide every year.
He added,” It can be mild but it can also lead to either rapid or progressive weakness and has the potential to affect the respiratory system. GBS could be caused by bacterial or viral infections and certain medicines or vaccines could predispose patients to develop the syndrome.
“We were acutely aware of it and it was part of the vigilance plan.”
Blokman said that the death which occurred in South Africa due to the COVID-19 vaccine has happened in other countries as well, although it is exceedingly rare with very few cases reported and even fewer are reportedly caused by the COVID-19 vaccine,
“We are convinced that the benefits of the vaccine still greatly outweigh adverse events,” said Blokman.
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The chairperson of SAHPRA, Helen Rees, said that the country is seeing such a rare side-effect only because the vaccine had been rolled out to millions.
Rees said, “We must be very careful to keep this event in proportion, We must ask what is the risk of the disease itself?”
She added that they were in discussions with the World Health Organization and other regulators and can confirm the death due to the COVID-19 vaccine to be very rare.
Dr Boitumelo Semete-Makokotlela, chief of SAHPRA said that this case was the first death linked to the COVID-19 vaccination after administering nine million doses of the vaccine.
She said the investigation was still ongoing in a number of other cases.
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Picture: SAHPRA
