South Africa has reported its second death from Guillain-Barre syndrome (GBS) following Johnson & Johnson’s (J&J) COVID-19 vaccination, the South African Health Products Regulatory Authority (SAHPRA) announced on Monday.
“The causality assessment of the reported case was carried out by the National Expert Committee on Immunization Safety (NISEC) using the World Health Organization (WHO) methodology,” explained SAHPRA.
“The case has been classified as a vaccine-related event following investigations and causality assessment. The events reported in the vaccine recipient met the case definition of GBS, and no other probable cause of GBS was identified at the time of illness.”
In August, SAHPRA confirmed the first GBS death linked to the J&J vaccine, also known as Janssen’s COVID-19 vaccine.
According to the local drug control agency, GBS is a very rare but potentially serious neurological side effect associated with the administration of various vaccines and other drugs. It can be caused by some bacterial or viral infections, including SARS-CoV-2.
Symptoms of GBS range from mild to severe, according to SAHPRA. These can include muscle weakness, muscle pain, numbness and tingling.
“In many cases, GBS goes away without serious consequences, but in some cases, GBS can cause serious or life-threatening problems.”
SAHPRA said in a statement that regulators had previously investigated reports of GBS linked to COVID-19 vaccines.
“They concluded that Janssen may increase the risk of GBS. Therefore, GBS is listed as a rare adverse event in the Professional Information (PI) for Janssen.”
Meanwhile, the investigation and causality assessment of all reported serious adverse events following immunization (AEFI) with J&J’s COVID-19 vaccine and others is ongoing, according to the regulator.
“The results of these investigations and causation assessments will be shared with the public as soon as they are complete.”
SAHPRA said it was important to note that the COVID-19 shots were consistently shown to prevent severe disease, hospitalization and death.
“Based on currently available data, SAHPRA has determined that the benefits of vaccination against COVID-19 far outweigh the very low risk of serious side effects, including GBS. The public is strongly advised not to delay vaccination against COVID-19 if it is consistent with the national vaccination program.”
In addition, SAHPRA encourages the public to report any suspected side effects after using all medicines and vaccines.
Reports can be made at a medical facility by downloading the Med Safety App https://medsafety.sahpra.org.za/, available for Android and iOS phones, or by calling the COVID-19 hotline on 0800 029 999.
More information on AEFIs reported for COVID-19 vaccines and how to report AEFIs is available on the SAHPRA website https://aefi-reporting.sahpra.org.za/. – SAnews.gov.za