Have any deaths been directly linked to Covid-19 vaccines?

One person in SA has died of Guillain-Barré syndrome (GBS) linked to receiving the Johnson & Johnson (J&J) Covid-19 vaccine.

The SA Health Products and Regulatory Authority (Sahpra) revealed this on Thursday, saying no patient details will be made public to protect confidentiality.

Sahpra said this is the first death in the country directly linked to the vaccine. More than 37-million vaccines have been administered, including more than 9-million J&J doses.

“Sahpra has been informed of a fatal case of GBS following vaccination with Covid-19 vaccine Janssen. A causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee using the World Health Organisation’s methodology. 

“The case was classified as a vaccine product-related event where immunisation with the Covid-19 vaccine Janssen was associated with the occurrence of GBS in the recipient. The events reported in the vaccine recipient were consistent with the case definition for GBS and no other likely cause of GBS was identified at the time of illness,” said the authority. 

According to Sahpra, GBS is a very rare but severe adverse event associated with the administration of 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 being mild to severe, and include muscle weakness, muscle pain, numbness and tingling,” it said.

“In many cases, GBS gets better with no serious after-effects, but in some cases it can become serious and cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate. 

“GBS-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.”

It said investigations and causality assessment of all severe reported adverse events following immunisation with Covid-19 vaccines are ongoing and will be shared with the public as they become available.

Last year, Reuters reported the US Food and Drug Administration added a warning to a fact sheet for the J&J Covid-19 vaccine, saying data suggested there was an increased risk of GBS in the six weeks after vaccination. It did however note the chances of getting GBS after vaccination as being “very low”.

At the time, the US had administered around 12.8-million J&J Covid-19 vaccines. It noted 100 preliminary reports of GBS in vaccine recipients, including 95 cases that led to hospitalisation and one reported death.