A second recipient of the COVID-19 Johnson & Johnson vaccine booster has died in South Africa. This has been confirmed by the South African Health Products and Regulatory Authority (SAHPRA) earlier today.
Since the start of the pandemic, this is South Africa’s second casualty out of 160 deaths investigated. SAPHRA confirmed the first GBS death early last month.
In a statement on Monday, Sahpra chief executive Dr Boitumelo Semete-Makokotlela said a second fatal case of Guillain-Barré syndrome (GBS) had been confirmed after the National Immunisation Safety Expert Committee (NISEC) did a causality assessment of the reported case using the World Health Organisation’s (WHO) methodology. The death was classified as a vaccine product-related event.
“It is with very sad hearts today that we report to you that SAHPRA has been informed of a fatal case of a syndrome called Guillain-Barre Syndrome, shortly referred to as GBS. This is a case that was noted following vaccination with the COVID-19 J&J Janssen vaccine,” said Dr Boitumelo Semete, CEO of SAHPRA.
According to Sahpra, Guillain-Barré syndrome (GBS) is a rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines.
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. As previously communicated, GBS is a very rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by some bacterial or viral infections, including SARS-CoV-2.”
It found the patient’s demise as a result of GBS can be tied to taking the Johnson & Johnson vaccine.
In many cases, the condition resolves with no serious after-effects, but in some severe instances, it can cause serious or life-threatening problems.
“Investigations and causality assessment of all reported severe AEFI 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.”
Previous investigations by regulatory authorities concluded the J&J vaccine might increase the risk of GBS. The syndrome is a rare adverse event in the professional information (PI) for COVID-19 Vaccine Janssen.
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 is strongly advised not to delay getting vaccinated against COVID-19 if eligible under the national vaccination programme. The authority also urged the public to report any suspected adverse events following the use of all medicines and vaccines.
The Janssen vaccine booster was approved last December. With 37,544,120 vaccines have been administered in South Africa. A total number of 9,210,329 J&J vaccine doses have been administered. The bulk of these was given in Gauteng Province.
~Bongani Siziba