SAHPRA confirms second vaccine-linked death in SA

The South African Health Products Regulatory Authority (SAHPRA) announced that a second person has died of Guillain-Barre syndrome (GBS) after receiving the Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine, in a statement on Monday, 12 September. The first fatal GBS case was publicised a little over a month ago on 4 August.

SA RECORDS SECOND VACCINE LINKED DEATH

SAHPRA said GBS is a very rare neurological adverse event, which could potentially be severe. It is associated with the administration of vaccines and other medicines. It can also be triggered by certain bacterial or viral infections, including SARS-CoV-2.

GBS symptoms range from mild to severe and may include muscle weakness, muscle pain, numbness and tingling. SAHPRA said the syndrome often resolves with no serious after-effects, however, it can cause serious or life-threatening complications in some cases.

World health regulatory authorities investigated reports of GBS associated with COVID-19 jabs in the past. It was found that the J&J vaccine may increase the risk of GBS; therefore, the syndrome is listed as a rare adverse event in the jab’s professional information.

“Recently, SAHPRA has been informed of a second fatal case of Guillain-Barré syndrome (GBS) following vaccination with the COVID-19 Vaccine Janssen.

“Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

The causality assessment and an investigation were completed and the latest fatal case was classified as “vaccine-product related event.”

SAHPRA said the events experienced by the vaccine recipient were consistent with the case definition of GBS and no other likely cause of the syndrome was identified at the time of illness.

The Regulatory Authority urged the public to take the COVID-19 vaccine as the jabs have shown to consistently prevent severe forms of disease, hospitalisation and death and based on the available evidence, the benefits of vaccination “far outweigh” the low risk of severe adverse events, including GBS.

The public is urged to report any suspected adverse events following the use of all medicines and vaccines. This can be done at a health facility, via the Med Safety App, or by calling the COVID-19 hotline at 0800-029-999.

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