The SA Health Products Regulatory Authority (SAHPRA) confirmed that another person died from Guillain-Barré syndrome (GBS) after receiving the Johnson & Johnson (J&J) Covid-19 vaccine. SAPHRA confirmed the first GBS death early last month.
In a statement released Monday, SAHPRA said the National Immunisation Safety Expert Committee (NISEC) did a causality assessment of the reported case using the World Health Organization’s (WHO) methodology. The death was classified as a vaccine product-related event.
GBS is a very rare but potentially severe neurological adverse event associated with administering various vaccines and other medicines. Some bacterial or viral infections, including SARS-CoV-2 can also trigger it, said SAHPRA.
“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 for COVID-19 Janssen vaccine.
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.
So far, 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. – Health-e News
*Reporting can be done at a health facility; by downloading the Med Safety App (https://medsafety.sahpra.org.za/), which is available for Android and iOS phones, or by calling the COVID-19 hotline at 0800 029 999.