- A second case of a rare syndrome linked to the Covid-19 vaccine has been confirmed.
- The person developed Guillain-Barré syndrome and died.
- The South African Health Products Regulatory Authority said the Covid-19 vaccination far outweighs the very low risk of severe adverse events such as GBS.
The South African Health Products Regulatory Authority (Sahpra) says a second death linked to the Covid-19 Johnson and Johnson vaccine has been confirmed.
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.
"Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organisation'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. 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."
The first GBS death related to the vaccine was reported in August.
Semete-Makokotlela said some symptoms of GBS range from mild to severe and may include muscle weakness, muscle pain, numbness and tingling.
"They concluded that Covid-19 vaccine Janssen may increase the risk of GBS. GBS is therefore listed as a rare adverse event in the professional information for Covid-19 vaccine Janssen."
Semete-Makokotlela said investigations and causality assessments of all reported severe adverse events following immunisation with the Covid-19 vaccine, Johnson and Johnson vaccine 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."
She said despite the deaths, the vaccines are still safe.
"Covid-19 vaccines have consistently been shown to prevent severe forms of disease, hospitalisation and death. 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 Covid-19 vaccination if eligible in terms of the national vaccination programme."
People who want to report suspected adverse events following the use of all medicines and vaccines can go to a health facility or download the Med Safety App. They can also call the Covid-19 hotline at 0800 029 999.