The South African Health Products Regulatory Authority (SAHPRA) has confirmed a second direct link between the death of a person who took the Johnson and Johnson vaccine.
As with the first case announced last month, the second also presented with the rare neurological disorder Guillain-Barre Syndrome (GBS).
SAHPRA says the causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology.
The case was classified as a vaccine product-related event following investigations conducted and causality assessment. 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.
What is GBS
GBS is a very rare but severe adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by infections such as SARS-CoV-2. GBS is a rare condition affecting the body’s immune system. Symptoms of GBS can vary from mild to severe.
Symptoms include muscle weakness, muscle pain, numbness, and tingling and in extreme cases, it can cause paralysis, breathing problems and abnormal blood pressure or heart rate.
SAHPRA urges the public to report any suspected adverse events following the use of all medicines and vaccines.
Reporting can be done at a health facility or 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.
More information regarding AEFIs reported for the COVID-19 vaccines and how to report an AEFI is available from the SAHPRA website: https://aefi-reporting.sahpra.org.za/.
